Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance

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Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
Prefeasibility Report
Expansion of API & Intermediates chemicals
          manufacturing unit of
     M/s. Unichem Laboratories Ltd.

Plot no. 99, MIDC Dhatav, Roha, district Raigad, Maharashtra. PIN-402116

                             Prepared by,
               Sadekar Enviro Engineers Pvt. Ltd.
 QCI-NABET Accredited EIA Consultancy for Schedule 5(f), Category-A
           MoEF Recognized and NABL Accredited Laboratory
 Plot no. A-95, Wagle Industrial area, Rd. no. 16, Kisan Nagar rd. Thane,
                       Maharashtra. PIN-400604

                               October 2018
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
Table of Content

Sr.                              Title                  Page no.

  1.   Executive summary                                1

  2.   Introduction of the project                      7

  3.   Project Description                              12

  4.   Site Analysis                                    20

  5.   Planning                                         21

  6.   Proposed infrastructure                          22

  7.   Rehabilitation and resettlement                  23

  8.   Project schedule and cost estimation             23

  9.   Analysis of proposal                             24
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

   1. Executive Summary
  Sr.      Component                                           Status
  No
 1     Name of Project            Expansion of API & intermediates manufacturing unit of M/s
                                  Unichem Laboratories Limited
 2       Location                 Plot No. 99 MIDC Dhatav, Roha Dist: Raigad
                                  Maharashtra, India. PIN: 402116
 3       Product Type             APIs and Intermediate chemicals
 4       Project Type             Expansion (Brown Field Project)
 5       Schedule as per EIA      5(f)
         Notification, 2006
 6       Category of Project      ‘A’
                                  (General condition is applicable- project site is within 5 km of
                                  notified eco-sensitive area)
 7                                         Area Details (in Sq. m.)
                                         Existing           Proposed                Total
 i.      Total Plot Area                48885.00                --                48885.00
 ii.     Built-up Area                  24496.46             2691.65              27188.11
 iii.    Parking area                       650                150                   800
 iv.     Greenbelt Area                    6790               967.46               7757.46
 8                                      Production Capacity (MT/Y)
                                         Existing           Proposed                Total
         Products                         377.77              122.23                 500
         (API             and
         Intermediate
         chemicals)
         By-product                          --               660                   660
         (Spent solvents)
 9                                 Budgetary Allocation (INR in lakhs)
 i.      Project Cost             1000
         (Expansion)
 ii.     Capital EMP Cost         670
 iii.    Recurring EMP cost       65
         (per annum)
 10                               Existing       Proposed                Total
         Man power (Nos.)         550            50                      600
 11                                   Power Requirement
                                  Existing     Proposed                    Total
 i.      Connected Load (KW)      3966         1250                        5216
 ii      Power demand KVA         2550         1000                        3550
 12                                    Fuel Requirement
                            Existing             Proposed                Total
 i       Furnace Oil (L/hr)
         Boiler (4T)                 250              --                            300
         TFH-2LKcal                  80               --                            80

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                    Page 1
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

         TFH-1 LKcal                     50                      --                 50
         Boiler (5T)                      --                   300                  300
         Total                           380                   300                  680
 ii.     HSD (L/hr)
         DG 180 KVA                      40                      --                 40
         DG 750 KVA                      130                     --                 130
         DG 1250 KVA                      --                   250                  250
         DG 1250 KVA                      --                   250                  250
         Total                           170                   500                  670
         Note: The consumption of high speed diesel will depend on the actual hours of power
         failure
 13                                          Utility Capacity
                             Existing                    Proposed       Total
 i.                                                                     4 TPH boiler (Standby)
         Boiler (T/hr)       4                           5
                                                                        5 TPH boiler (Primary)
 ii                                                                     DG 180 KVA
                             180 kVA                     1250 kVA       DG 750 KVA
         D.G. Set
                             750 kVA                     1250 kVA       DG 1250 KVA
                                                                        DG 1250 KVA
 14      Water
         Consumption         350                         240            590
         (CMD)
 15                                          Scrubber Details
                           11 unit of alkali        3 units of alkali  14 units of alkali
                              scrubber               scrubbers          scrubbers
         Scrubber         
                             2 units of acidic       9 units of acid    11 units of acid scrubbers
                             scrubber                scrubbers
 16                                            Stack Details
 i.                                                                     Common stack 35 m for
         Boiler Stack        35 m                             -         existing and proposed
                                                                        boiler
 ii.                         21 m                                       21 m
         TFH stack                                            --
                             23 m                                       23 m
 iii.                                                5 m above roof     All scrubber stacks shall
         Scrubber Stack      3 m above roof
                                                                        be 5 m above roof
 iv.                                                                    All DG set stacks shall
         D.G. Set            3 above roof            3 m above roof
                                                                        be 3 m above roof

 17                                            Effluent Details
 i       Sewage (CMD)             40                     --             40
 ii      Effluent (CMD)           150                    93             243

 18                                               ETP Details
                                          Existing         Proposed               Total

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                   Page 2
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

 i.         ETP capacity
                                            300                 --                   300
            (CMD)
                                   Effluent stream segregation will be done in high load and low
                                    load streams.
                                   ETP consisting Pre-primary, Primary and secondary and
                                    tertiary treatment. In this ETP low COD and Low TDS effluent
                                    is being treated.
                                   High COD and High TDS is being treated through Strippers 2
                                    Nos., three stage Multiple effect evaporator (MEE) and
                                    Agitator thin film dryer (ATFD). MEE condensate will be
                                    mixed with low COD in aeration tank. Treated effluent from
                                    ETP will be sent to Common Effluent Treatment plant for
                                    further treatment.
 ii.        Effluent treatment     For low TDS and Low COD Main collection Tank (500M3),
                                   Neutralisation tank (50M3), Aeration Tank No. 01 (1000M3),
                                   Aeration Tank No. 02 (650M3), Aeration Tank No. 03 (650
                                    M3), and aeration tank no. 4 or Bioreactor (150M3), Clarifier
                                    No. 1 (50M3), and Clarifier No. 2 (50M3), feed tank (100M3).
                                    Pre tertiary tank (50M3), and post tertiary tank (50M3)Clarifier
                                    No. 3 (50M3),
                                   For High COD and TDS, collection Tank no. 1 (50M3),
                                    collection Tank no. 2 (50M3), primary treatment tank No. 1
                                    (15M3), tank No. 2 (15M3), and Primary treatment tank No. 3
                                    (60M3), Stripper No. 1, Stripper No.2, Multiple Effect
                                    Evaporator, (MEE) and Agitated Thin Film Drier.
                                  Sewage will be treated in septic tank and the overflow will be
 iii.       Sewage treatment
                                  mixed with process effluent in aeration tank of ETP.
                                  Treated effluent is discharged to CETP. After expansion same
 iv.        Effluent disposal
                                  practice shall be followed.
 19                                     Details of Hazardous Waste
               (vide Hazardous and Other Wastes (Management and Transboundary Movement)
                                                  Rules, 2016)
            Particulars     HW      Existing        Propose Total          Method of Disposal
                            Categ
                            ory*
            Used/spent oil 5.1      1 MT/A          2 MT/A       3 MT/A Sale to authorized
       i.                                                                  recyclers /Disposal to
                                                                           CHWTSDF,
            Distillation                            4.5          7.5       Disposal to CHWTSDF, /
      ii.                   20.3    3 MT/A
            residues                                MT/A         MT/A      Co-processing
                                                                           Recycle, reuse/sale to
            Spent                                    400         660
  iii.                      28.6    260 MT/A                               authorized recyclers
            Solvents                                MT/A         MT/A
                                                                           /Disposal to CHWTSDF
            Discarded                                                      Disposal to CHWTSDF,
                                    4000
  iv.       containers      33.1                    1000         5000      /Sale to authorized
                                    Nos./A
            barrels/liners/                                                recyclers
M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                     Page 3
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

           plastic bags/
           PPEs
           Chemical
           sludge from                                        35        Disposal to CHWTSDF, /
     v.                     35.3      18 MT/A      17 MT/A
           wastewater                                         MT/A      Co-processing
           treatment
                                                                        Co-processing/ Sale to
           Evaporator                              5500       5500
     vi.                    37.3      --                                authorized recyclers/
           residue                                 MT/A       MT/A
                                                                        Disposal to CHWTSDF,
                                                              42        Disposal to CHWTSDF, /
 vii.      Spent catalyst   28.2      20 MT/A      22 MT/A
                                                              MT/A      authorized Co-processing
           Date expired
viii.                       28.4                   1 MT/A     2 MT/A    CHWTSDF
           products
           Off                        2 MT/A
     ix.   specification    28.5                   1 MT/A     2 MT/A    CHWTSDF
           products
           Spent mother
     x.                     --        2 MT/A       --         --        CHWTSDF
           liquor
           Ash from
           incinerator
     xi.   and flue gas     37.2      1 MT/A       4 MT/A     5 MT/A    CHWTSDF
           cleaning
           residue
           Spent ion
           exchange
                                                   1.5
 xii.      resin            35.2      0.5 MT/A                2 MT/A    CHWTSDF
                                                   MT/A
           containing
           toxic metals
           Spent carbon
                                                              19.5
xiii.      or filter        36.2      0.5 MT/A     19 MT/A              CHWTSDF
                                                              MT/A
           medium
           Waste/residue
 xiv.                       5.2       1 MT/A       1 MT/A     2 MT/A    CHWTSDF
           containing oil
           Oil grease
 xv.                        35.4      --           2 MT/A     2 MT/A    CHWTSDF
           skimming
           Contaminated
           cotton rags or
 xvi.                       33.2      --           1 MT/A     1 MT/A    CHWTSDF
           other cleaning
           materials
           Residue and                                        81        CHWTSDF/ Authorized
xvii.                       28.1      15 MT/A      66 MT/A
           waste                                              MT/A      co processing company

 20                                     Details of Non-Hazardous Waste
           Particulars             Existing     Proposed Total         Method of Disposal
 I         plastic waste                                               Sale to MPCB approved
                                   -            12 MT/A    12 MT/A
           (Poly bags, HDPE                                            scrap dealers/recyclers

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                 Page 4
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

         drums, HDPE
         carboys)
 2       Glass bottles          --         500 nos.      500 nos.
 3       Fiber drums,
                                --         5000 nos.     5000 nos.
         wooden pallets
 4       Paper waste,           --         5 MT/A        5 MT/A
 5        MS/SS scrap, MS       --         50 MT/A       50 MT/A
         drums
 6       e-waste Waste
         Particulars            E Waste      Existing    Proposed    Total     Method of
                                Category                                       Disposal
 i       Personal Computers
         (Central Processing
                                ITEW2        --          20 kg/A     20 kg/A
         Unit with input and
         output devices)
                                                                               Sale to MPCB
 ii      Personal
                                                                               authorised
         Computing: Laptop
                                                                               recycler/returne
         Computers
                                ITEW3        --          10 kg/A     10 kg/A   d to
         (Central Processing
                                                                               manufacturer/su
         Unit with input and
                                                                               pplier
         output devices)
 iii     Printers including
                                ITEW6        --          3 kg/A      3 kg/A
         cartridges
 iv      Telephones             ITEW12       --          1 kg/A      1 kg/A

 21                                   Details of biomedical Waste
                    (vide Bio-Medical Waste (Management and Handling) Rules, 2016)
         Particulars               BMW         Existing Proposed Total Method of
                                   Category                                Disposal
 i       Soiled waste                                                      Disposal to
         (Items contaminated                                               CBMWTF/MPC
         with blood, body fluids                                           B authorized
         like dressings, plaster                                           processor for
                                   Yellow      --        1 MT/A   1
         casts, cotton swabs and                                           Raigad region
         bags containing residual
         or discarded blood and
         blood components)
 ii      Expired medicines
         (Pharmaceutical waste
         like antibiotics,
         cytotoxic drugs
                                   Yellow      --         1MT/A   1
         including all items
         contaminated with
         cytotoxic drugs or
         plastic ampoules)
 iii)    Microbiology,             Yellow      --        2 MT/A   2

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                Page 5
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

         Biotechnology and
         other clinical
         laboratory waste:
         Blood bags, Laboratory
         cultures, stocks or
         specimens of
         microorganisms,
         live or
         attenuated vaccines,
         human and animal cell
         cultures used in
         research, industrial
         laboratories, production
         of biological, residual
         toxins, dishes and
         devices used for
         cultures

 22                                       Details of battery Waste
                         (vide Batteries (Management and Handling) Rules, 2001)
 i       Lead batteries from                                 20      Return to supplier/MPCB
                                     --         20 Nos./A
         D.G. Sets, UPS system                               Nos./A  authorized party

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                             Page 6
Prefeasibility Report Expansion of API & Intermediates chemicals manufacturing unit of M/s. Unichem Laboratories Ltd - Environmental Clearance
M/s. Unichem Laboratories Ltd.

2.   Introduction of the project

Unichem Laboratories Ltd. was established with a vision to provide high quality Intermediates
and Active Pharmaceutical Ingredients to the global pharma industry.

The Active Pharmaceutical Ingredient (API) business requires strong infrastructure,
technological expertise, experience and capability to carry out contract manufacturing and
custom synthesis. Unichem provides customers a complete solution for API development,
starting from samples and trial quantities to regulatory assistance required for registration and
regulatory compliance.
The company’s facilities are designed to meet the highest global standards for API development
with a focus on complex APIs, controlled substances and APIs for regulated markets, all of
which are key to achieving Unichem’s strategic goals.

Roha site is located in an area 48885 m2, having multiple manufacturing plants. The site handles
many reactions such as Hydrogenation, Nitration, Ethoxylation, Grignard Reaction and various
types of unit processes

The site is also certified as per:

        OHSAS 18001:2007 for Occupational health and safety.
        ISO 14001:2015 for environmental compliance.
        USFDA
        EDQM

  The project is located in plot no. 99, MIDC-Dhatav a notified industrial area by state
government of Maharashtra. The notification is attached as annexure-I. Dhatav MIDC lies
within 5 km distance of Dhatav village which is a notified eco sensitive area. Therefore the
project holds category “A” as the general condition is applicable to the expansion project.
However public hearing is exempted due to existence of the project in notified industrial area.

2.1 Expansion Details
As Unichem is 100% catering to the International markets, with increase in the demand in the
international markets company has planned capacity enhancement of the Roha unit. Expansion
of this project is for API and intermediates. The Existing Production Capacity is 377.77 MT/A
and Proposed Production Capacity after expansion shall be 500 MT/A. The industry expands
with the increase in capacity and proposed for the new products.(Total Capacity – 500 MT/A ;
660 MT/A byproducts)

2.2 Need of the Project and its importance to the country:

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                   Page 7
M/s. Unichem Laboratories Ltd.

     Proposal to enhance the manufacturing capacities of the existing plants and set up 01
      independent plant for API intermediates which will be built as per cGMP requirements and
      shall meet international standards set in by major regulatory authorities such as US FDA,
      EDQM , TGA-Australia and others
     Proposed enhancement is outcome of increase demand of API in the international markets /
      internal consumers. Intermediates facility is being set up to cater the increase internal
      demand of the same plant because of increase in API capacities as well as to reduce the
      dependability from the external parties for intermediates.
     Total Installed capacity of the plant will be 500 metric tons per Annum for all the plants put
      together.
     Facility shall comply with Gas Cylinder Rules & Petroleum storage Rules.
     Fire alarm and gas/smoke detection system and escape routes shall be installed to meet the
      requirements of relevant National Standards together with portable fire extinguishers as
      necessary.
2.3         Demand supply gap:

International as well as Domestic demand of the various products proposed to be manufactured
by the company & the proposed installed capacity is as under

Sr. No.           Product Name      Production Qty. in     International         Domestic Demand
                                    MT/A                   Demand in MT          in MT
      1.      Amlodipine Besylate            11                     Y                   Y
      2.      Amlodipine Maleate              2                     Y                   Y
      3.          Apixaban                    1                     N                   Y
      4.         Aripiprazole                0.3                    Y                   Y
                                             0.5                    N                   Y
      5.            Baclofen

      6.      Bendroflumethiazide             2                     Y                    Y
      7.      Bisoprolol Fumarate            10                     Y                    Y
                 Buprenorphine               0.5                    Y                    Y
      8.
                 Hydrochloride
                   Clonidine                 0.5                    Y                    Y
      9.
                 Hydrochloride
                   Donepezil                 0.5                    Y                    Y
      10.
                 Hydrochloride
      11.     Doxazosin Mesylate             1                      N                    Y
      12.     Hydrochlorothiazide           130                     Y                    Y

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                      Page 8
M/s. Unichem Laboratories Ltd.

                 Labetalol                 5                     N                Y
    13.
               Hydrochloride
    14.          Lacidipine               0.5                    Y                Y
    15.         Meloxicam                  12                    Y                Y
    16.        Metronidazole              250                    Y                Y
    17.         Paliperidone              0.5                    Y                Y
    18.          Piroxicam                0.5                    Y                Y
                Pramipexole               0.2                    Y                Y
    19.       dihydrochloride
               monohydrate
                 Prasugrel                0.5                    Y                Y
    20.
               Hydrochloride
    21.         Rivaroxaban                1                     Y                Y
    22.    Rizatriptan Benzoate           0.5                    N                Y
    23.    Solifenacin succinate.         0.2                    N                Y
    24.           Tadalafil               0.5                    N                Y
                Tamsulosin                0.5                    N                Y
    25.
               Hydrochloride
                Teneligliptin             0.5                    N                Y
    26.
              Hydrobromide
    27.        Teriflunomide              0.5                    Y                Y
                 Tigagibine               0.5                    N                Y
    28.
               Hydrochloride
                 Tizanidine               0.2                    Y                Y
    29.
               hydrochloride
    30.     Tofacitinib citrate.          0.5                    N                Y
    31.     Tolterodine Tartrate          0.2                    N                Y
                Vortioxetine              0.5                    N                Y
    32.
              Hydrobromide
    33.         Zolmitriptan              0.2                    N                Y
           4-( 4-fluorobenzoyl )          60                     Y                N
            butyric acid ( Keto
    34.
                   Acid )

                IDN(Taxol)                0.5                    Y                N
    35.
              R & D Product               5.0                    Y                Y
    36.

Imports vs. Indigenous Product:

The raw material is imported as well as purchased indigenously. The major raw materials are
domestically purchased some of the specialty chemicals required as raw material are imported
due to manufacturing shortfall in the domestic market.

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                               Page 9
M/s. Unichem Laboratories Ltd.

Export possibility: Regulated market like US, EU & RoW

Expected Sales out of the above products-
The estimated sales out of the above products are given hereunder: (Rs. In crs)
Sr.No.    Name Of Products                                                        Name Of Products

   1.     Amlodipine Besylate

   2.     Amlodipine Maleate

   3.     Bisoprolol Fumarate

   4.     Clonidine Hydrochloride

   5.     Doxazosin Mesylate

   6.     Labetalol Hydrochloride

   7.     Lacidipine

   8.     Bendroflumethiazide

   9.     Hydrochlorothiazide

   10.    Aripiprazole

   11.    Paliperidone

   12.    Tigabine Hydrochloride                                                   Rs.140 Crores
   13.    Apixaban

   14.    Rivaroxaban

   15.    Baclofen

   16.    Buprenorphine Hydrochloride

   17.    Donepezil Hydrochloride

   18.    Piroxicam

   19.    Meloxicam

   20.    Metronidazole

   21.    Pramipexole dihydrochloride monohydrate

   22.    Prasugrel Hydrochloride

   23.    Zolmitriptan

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                    Page 10
M/s. Unichem Laboratories Ltd.

   24.    Rizatriptan Benzoate

   25.    Solifenacin succinate.

   26.    Tadalafil

   27.    Tamsulosin Hydrochloride

   28.    Teneligliptin Hydrobromide

   29.    Teriflunomide

   30.    Tizanidine hydrochloride

   31.    Tofacitinib citrate.

   32.    Tolterodine Tartrate

   33.    Vortioxetine Hydrobromide

   34.    4-( 4-fluorobenzoyl ) butyric acid ( Keto Acid )

   35.    IDN(Taxol)

   36.    R & D Products

                                                              Total           Rs. 140 Crores

Employment generation:

The proposed expansion will generate employment for skilled as well as non-skilled labour.

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                 Page 11
M/s. Unichem Laboratories Ltd.

3. Project Description

(I) Non-violation of EIA notification, 2006

The existing API and intermediates manufacturing project is located in the notified industrial
area-MIDC, Dhatav. Valid consent to operate : ‘Formate 1.0/ BO/CAC-Cell/ EIC No RD-3222-
16/14th CAC/3317’ dated 08.03.2016 valid up to 30.04.2020. Existing API and intermediates
manufacturing capacity of the production unit is 377.77 MT/A. The valid CTO is attached as
annexure V. Existing unit is established in 1994. therefore the unit does not hold prior EC. The
manufacturing capacity of the plant is unchanged since 2006. The CTO of the plant of
21.04.2004 is attached as annexure VI .

The existing unit complies with the applicability of EIA notification, 2006 and does not comes
under violation of EIA notification, 2006.

The Proposed Expansion is in the existing plant so no alternate site is considered.

(II) Size or Magnitude of Operation:

Sr        Product Name           Therapeutic       Existing (MT/A) as        Proposed     Total
No.                               Category             per consent            (MT/A)     (MT/A)
                                                     1.0/BO/CAC-
                                                   Cell/EIC No. RD-
                                                      3222-16/14th
                                                       CAC/3317

1.         Amlodipine                                      20.0                  -9         11
            Besylate
2.         Amlodipine                                                            -1          2
            Maleate
                                                             3

3.         Bisoprolol                                      8.00                  2          10
            Fumarate               Anti-
                                Hypertensive
4.         Clonidine                                       0.25                 0.25       0.50
          Hydrochloride
5.         Doxazosin                                         0                   1           1
            Mesylate
6.          Labetalol                                        5                   0           5
          Hydrochloride
7.         Lacidipine                                      0.02                 0.48        0.5

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                 Page 12
M/s. Unichem Laboratories Ltd.

8.      Bendroflumethiazi          Anti-              2             0          2
               de               Hypertensive,
9.      Hydrochlorothiazi         Diuretic            60            70        130
               de
10.       Aripiprazole                                0.2           0.3       0.5

11.        Paliperidone       Anti-psychotic          00            0.5       0.5

12.         Tigabine                                 0.02          0.48      0.50
          Hydrochloride
13.         Apixaban            Anticoagulant         0             1          1

14.        Rivaroxaban                                0             1          1

15.          Baclofen          muscle relaxant        0             0.5       0.5
                               and antispastic.
16.     Buprenorphine           Post operative       0.02          0.48      0.50
        Hydrochloride             analgesic
17.    0 Donepezil             Anti Alzheimer        0.08          0.42       0.5
        Hydrochloride          (In treatment of
                                  Nootropic)
18.         Piroxicam                Anti             0             0.5       0.5
                                Inflammatory
19.         Meloxicam                Anti             5             7         12
                                Inflammatory
20.       Metronidazole        Anti Protozoal,       269           -19.0      250
                                Anti Amoebic
21.        Pramipexole               Anti-           0.02          0.18       0.2
         dihydrochloride         Parkinsonian
          monohydrate
22.         Prasugrel           Antithrombotic        0             0.5       0.5
          Hydrochloride        and Antiembolic
                                agents, Platelet
                                 Aggregation
                                  Inhibitors
23.        Zolmitriptan          Anti migraine       0.02          0.18       0.2

24.         Rizatriptan                              0.01          0.49       0.5
             Benzoate
25.         Solifenacin          Treatment of         0             0.2       0.2
             succinate.            overactive
                               bladder in adults
                                with symptoms
                                of urge urinary
                                 incontinence,
                               urinary urgency

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                    Page 13
M/s. Unichem Laboratories Ltd.

                                 and urinary
                                 frequency.
26.          Tadalafil             Erectile              0            0.5        0.5
                                 Dysfunction
27.        Tamsulosin          In treatment of         0.01           0.49       0.5
          Hydrochloride        benign prostatic
                                hypertrophy.
28.        Teneligliptin         Antidiabetic            0            0.5        0.5
          Hydrobromide
29.       Teriflunomide            Multiple              0            0.5        0.5
                               sclerosis (MS)-
                                 pyrimidine
                                  synthesis
                                  inhibition
30.        Tizanidine          Muscle relaxant         0.05           0.15      0.20
          hydrochloride
31.     Tofacitinib citrate.    Rheumatoid               0            0.5        0.5
                                   arthritis
32.         Tolterodine        Anti-muscarinic         0.05           0.15       0.2
              Tartrate
33.         Vortioxetine       Antidepressant            0            0.5        0.5
          Hydrobromide
34.            4-( 4-                                    0            60         60
          fluorobenzoyl )
           butyric acid (
            Keto Acid )

35.        IDN(Taxol)                                    0            0.5        0.5

36.       R & D Product                                  0            5.0        5.0

37.        Brimonidine         Anti-Glaucoma           0.02            0          0
             tartrate

38.         Finofibrate          Anti-Hyper              5             0          0
                                  lipidemic
        Total production                              377.77         127.25      500

           By-products

1.         Spent solvent                                --            660        660

(III) Manufacturing process details of Processes with flow charts:

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                       Page 14
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The manufacturing process with material balance of major product is attached as Annexure II.

(IV) List of the Raw Material with Quantity & Import Local Details:

List of raw materials with quantity required for manufacturing all products are attached as
Annexure III

(V) Resource optimization/recycling and reused envisaged in the project, if, should be
briefly outlined.

Maximum focus will be given during the project to ensure optimization of resources and reuse
wherever possible. Following are few initiatives which are planned during the project:

         Solvent recovery system – Solvent recovery system is being set up to recover the solvents
          used in the process so that it can be reused. This will help in terms of reduction in the
          hazardous waste as well as reduction in VOC emissions.
         Salt sale as by product – Salts generated during the process is planned to sell to other
          industries that can use it as raw material. This will help in terms of reduction in
          hazardous waste quantities as well ensure use of the resource.
         Steam condensate recovery – Steam condensate recovery to planned to implement which
          can help in terms of reduction in water consumption, reuse of the energy and their by
          reduction in fuel consumption.
         Co processing of hazardous waste – It is planned to send the hazardous waste generated
          during the processed to authorized co processing companies e.g. Cement Industries who
          can use it as fuel. This will help to reduce the burden on the environment as well as
          conservation of resource

(VI) Water Requirement-Source: MIDC
   Existing Water Requirement: 350 CMD
   Proposed Water Requirement: 590 CMD

          Water Budget:
Sr.       Activity/Process             Existing Project                  After expansion
No.
                               Quantity      Loss     Effluent   Quantity      Loss   Effluent     Recycle
                               of Water                          of Water
                               Required                          Required
                               in CMD                            in CMD

  1           Domestic           50           10          40       50           10         40
  2            Process           180          62          118      130         0.2         141
              scrubber                                              15          3          12
  3       Industrial cooling     80           48          32       245         210         35

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                          Page 15
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             Boiler feed                                             100       25         55        20
  4          Green belt             40            40                  50       50          0
               TOTAL               350           160         190     590      298.2       283       20

       Power Requirement-Source: MSEB.
          Connected Load:                  4000 + KW (Existing) +    2000      KW (Proposed )
          Existing Power Demand            2550 KVA + Proposed Power Demand: 1500 KVA
           Utility details
          Alternate Source for Power: DG SET
      1. Capacity : 750 KW x 1 nos (Existing)
                      : 180 KW x 1 nos (Existing)
                             1500 KW x 2 nos (Proposed)
           Fuel requirement – 670 liter / hr.
      2. Fuel Type: HSD
      3. Consumption: HSD : 3000 L/day (D.G. Set will only be operational during power
           failure)
      1. Characteristics of the effluent

      Parameters           Inlet effluent          Outlet effluent   Effluent Discharge
      (pH, BOD,                                    Characteristic    Standards (CPCB/MPCB)
                           Charact-eristic
      COD, etc.)

      pH                         2.5 to 3                5.5 to 9

      BOD                      7000 mg/L               < 100 mg/L
M/s. Unichem Laboratories Ltd.

Design of Existing Effluent Treatment Plant: Biological Treatment Plant

          Sr. No     Unit                      Quantity     Capacity     MOC
          1          Screen Chamber            1              0.5 Kl     RCC
          2          Oil trap                  2              1 Kl       RCC

          3          Main Equalization Tank    1             500 Kl      RCC

          4          Primary Tank              1              40 Kl      RCC

          5          Feed Balance Tank         1             100 Kl      RCC

          6          Aerator                   1             1000 Kl     RCC

          7          Aerator                   2            650 Kl x 2   RCC

          8          Clarifier                 1              50 Kl      RCC

          9          Clarifier                 2            40 Kl x 2    RCC

          10         Treated Water Tank        2            50 Kl x 2    RCC

          11         Pressure sand Filter      2             5 M3/hr     RCC

          12         Activated Carbon Filter   2             5 M3/hr     RCC

          13         Sludge Drying bed         6                         RCC

          14         V-Notch                   1              0.5 Kl     RCC

         15       BR Tank                      3              50 kl      RCC
        Proposed MEE / ATFD Plant

          Sr.no Description                  Quantity     Capacity       MOC
            1   High TDS collection             2            50KL         RCC
                tank
            2   Neutralization tank             3            15 Kl        RCC
            3   Feed Balance tank               2             1 Kl        MS

               4   Stripper Column              2                          MS
               5   Solvent collection tank      1             1Kl          MS
               6   MEE Feed Tank                1             1Kl          MS
               5   MEE Effect                   3            40 M3       SS316 Ti
               6   ATFD                         2                          MS

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                             Page 17
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            7     ATFD Main collection    2       32 Kl     RCC
                  Tank
            8     ATFD feed balance       1       0.8 Kl     MS
                  Tank
            9     Process condensate      1       15 Kl      MS
                  Tank
            10    Seal Cooling Tank       1       1 Kl       Ms
            11    CIP Tank                1       7 Kl       MS

M/s. Sadekar Enviro Engineers Pvt. Ltd.                               Page 18
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  (X) Schematic Representation of the Feasibility Drawing of EIA

       RESOURCE CONSUMPTION                                  POWER CONSUMPTION

                (WATER)

                                            RAW MATERIAL

                                      PRODUCTION ACTIVITY

           WASTE GENERATION
                                                            FINISHED PRODUCTS

                          Hazardous Waste
Emission     Effluent
   s
                                CHWTDSF
Scrubber
                                 TALOJA
           Proposed ETP
                                                                     MARKET
             25 CMD

                                       EMPLOYMENT

   POLLUTION ABATEMENT

           ABATEMENT

                                                                     ECONOMY

  M/s. Sadekar Enviro Engineers Pvt. Ltd.                                        Page 19
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4. Site Analysis

This industry is located in Dhatav MIDC Roha

  I.       Connectivity: Distance from Industrial Area
          Nearest railway station : Roha 05 Km
          Nearest Airport: 120 km. Mumbai Airport.

           Location and Access

           The industrial area is centrally located and easily accessible through all modes of
           transport

          Road: The entire industrial area is well connected by internal roads Available Road
           Network: State Highway No.17 –Mumbai-Goa within 10 km from the site.
          Railway: Roha Railway Station is in close proximity, situated about 5 Km. away from
           area.
          Air: Mumbai Air Port is located, around 120 Km away from the site.

 II.       Land Form, Land use and Land Ownership: The Project location is in the notified
           industrial zone i.e. MIDC Dhatav Roha.

Topography: The location of industry is in notified Area. The land is developed by MIDC and
infrastructure provided by MIDC.

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                          Page 20
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        2. Latitude : 18°43'16.10"N
        3. Longitude : 73°15'20.94"E
        4. Location : Plot No. 99 MIDC Dhatav Roha 402116.
        5. Elevation above Mean Sea Level (meters): 582 meters
 III.      Existing project and proposed project are in the same premises located in Dhatav
           Roha 402116.
 IV.       Existing Infrastructure:
           The industry is having the facilities like canteen, lavatory and assembly hall, utility

           Department, Garden etc.

  V.       The Attached Plant Lay out - Annexure IV
 VI.       Soil Classification
             The physical setting of the Raigad district is divided into three main parts namely
           Eastern ranges, Central ranges and Southern ranges. Eastern and Central ranges have
           black soil formed from 'lava' and at some places it has large tracks of fertile land. The
           western ranges are mostly hilly and have red soil. The majority area in the west is under
           thick forest coverage.

          Climatic data (Secondary source)

VII.       Raigad climate is a blend of coastal and inland elements common to Maharashtra. The
           temperature has a relatively narrow range between 10 °C to 35 °C. Summer in Raigad is
           comparatively hot, but much more humid, than neighbouring inland cities. Maximum
           temperatures rarely exceed 40 °C and typically range between 33 and 35 °C. Lows during
           this season are around 24 °C to 26 °C. The year is divided into four seasons; the summer
           – March to May, the rainy – June to September, the post monsoon – October to
           November & the winter - December to February

VIII.      Social Infrastructure available:
           Hotels, Motels, sports ground, public ground, public garden, petrol pumps, school,
           hospital, roads, railway station is available around the project location.

 M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                         Page 21
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5. Planning Brief

The total Plot area is 48885 sq. m. The green belt area will be 6790 sq. m. New infrastructure
will be erected. Power supply will be taken from MSEB and water supply will be provided by
MIDC. In the industry premises demarcated storage area will available for the raw material and
finished product. The industry will have lavatory and garden etc. In the industry all necessary
safety and firefighting equipment’s like Hydrant, Sprinkler, Detector System, Fire Extinguishers.

6. Proposed Infrastructure

(i)   Industrial Area: MIDC, Dhatav, Roha, Raigad – 402116 - Maharashtra state.

(ii) Residential Area: Not applicable.

(iii) Green Belt: Nil.

(IV) Social Infrastructure and (V) Connectivity

          Road: MIDC has provided asphalt roads with widths varying from 3.75 to 16 m; these
           are mainly two lane roads with a central verge of bougainvillea
          Water: MIDC supply.
           consumption of water would be 350 CMD, (Existing –350 & Proposed – 240 )
          Electricity:
          Existing: -   Connected load:    3996 kW

                         Maximum Demand: 2550 KVA

          Proposed: -    Connected load:        2000 kW

                         Maximum Demand:        1500 KVA

          Streetlights: MIDC has provided street lighting facility in the area;
          Telecommunication Facility / Connectivity: Fax, telex, email and Internet facilities
           are available. A telephone exchange is located in the area.
          Fire Station: A fire station is 1 KM distance.

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                   Page 22
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            Common Effluent Disposal Facility: MIDC has constructed a common effluent
             treatment plant of capacity 22 MLD
(VI) Source of the Water will be MIDC. The daily water requirement will be 350 CMD

            (Existing – 350 & Proposed – 240)

(VII)       Domestic Waste water will be treated in the effluent treatment plant

(VIII) The Industrial Waste will be disposed of to CHWTSDF Taloja.

(IX) The non-hazardous Solid Waste generated like empty drums will be returned to
manufacturer.

(X) The Power Requirement:

            Existing: -      Connected load: 3996 kW
                             Maximum Demand: 2550 KVA

            Proposed: -      Connected load:    2000 kW
                             Maximum Demand: 1500 KVA
7. Rehabilitation & Resettlement (R & R) Plan: Not Applicable. The expansion project shall
be executed on the existing plot located in notified industrial area MIDC-Dhatav.

8. Project Schedule & Cost Estimates

1. The proposed schedule for approval and implementation.

             Sr.          Description                                Time          Cost in %
             No.
               1. Obtaining all statutory permission with        7 Months 2%
                  respect to industry
           2.     Design and Engineering Plan                    3 Months 15%
           3.     Factory Set Up                                 8 Months 70%
           4.     Testing and Commissioning                      1 Months 13%
           5.     Actual Starting                                1 Months --
Estimated project cost along with analysis of economic viability of the project.

The infrastructure already exists but for implementation of the new project the minor
Construction will be required.

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                        Page 23
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9. Analysis of proposal (Final Recommendations)

       The project will provide employment opportunities to local people and it will increase the
living standard. As the industry has the export market it will add to the net foreign exchange
earning of the country. In view of the above points it is concluded that the project proposal will
not have any negative impact on the environment and people on the other hand will have positive
impact by improving the socio economic aspects with employment generation.

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                   Page 24
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                Annexure I- Notified Industrial Area MIDC –Dhatav Gazette

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                               Annexure II- Manufacturing details

1. Metronidazole

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                               Annexure III- Raw material Details

Sr.                    Raw Material                     Existing    Proposed    Imported
No.                                                      Qty.         Qty.       /Local
   1   Methanol                                            180643      744690   LOCAL
   2   (IDN-IV) (IDN 6003)                                      0       485.0   LOCAL
   3   (S) -4- (4 Amniobenzyl)-2-Oxazolidinone              38.07      380.71   IMPORT
   4   (R)-(+) α-Methyl Benzylamine                         29.21      1460.5   LOCAL
   5   (S)-(+ )-glycidyl pthalimide                             0      1602.9   LOCAL
   6   (S)tetrahydroisoquinolineTartrate SLF -I                 0       297.5   LOCAL
   7   (R)-(-)-3-Quinuclidinol                                  0       108.5   LOCAL
   8   10% Palladium on Charcoal                            12.33      428.30   LOCAL
   9   1-methyl-3-phenylpropylamine (MPPA)               25249.60    25249.60   IMPORT
  10   1-Bromo-4-Chlorobutane                              926.47     2316.18   LOCAL
  11   1-(2,3-Dichlorophenyl) Piperazine                   344.49      861.21   LOCAL
  12   10% Palladium on Carbon (Type 39K Paste)              7.79       389.5   LOCAL
  13   2-(2-Ethoxyphenoxy) Ethyl Bromide                    14.33      716.36   LOCAL
  14   2,2-Azobisisobutyronitrile                               0        24.8   LOCAL
  15   1,2-Dichloro benzene                                     0      3950.3   LOCAL
  16   2-Amino-5-Methyl thiazole                          2094.41     5026.60   LOCAL
  17   2,6-Dichloroaniline                                 452.24      904.49   IMPORT
  18   2,4-Dinitroaniline                                   65.15       65.15   LOCAL
  19   2-Bromobenzaldehyde                                  12.29      614.49   IMPORT
  20   2,4-Dimethoxy Benzaldehyde                               0      279.02   IMPORT
  21   2-Amino pyridine                                         0       295.7   LOCAL
  22   2,6-di-tert-butyl-4-methyl phenol (BHT)                  0        14.9   LOCAL
  23   2,4-Dimethyl thiophenol (DMTP)                           0       870.3   LOCAL
  24   2-Methyl Imidazole (Crude) Stage-I               815717.35   758101.85   LOCAL
  25   2-METHYL IMIDAZOLE -IV(PURE)                     489430.41   454861.11   LOCAL
  26   2-MNI (Crude)                                    927800.65   862268.51   LOCAL
  27   3-(2-methoxy-5-methylphenyl)-3-phenylpro            193.30       773.2   IMPORT
  28   2-Nitrophenyl Sulphenyl Chlo. (IDN 5954)                 0       280.1   LOCAL
       3-(2-chloroethyl)-6,7,8,9-tetrahydro-2-methyl-
       9-hydroxy-4H-pyrido[1,2-a ]pyrimidine-4-one
  29   (CMHTP)                                                  0       735.8   IMPORT
  30   2-Oxothienopyridine                                      0      1061.1   LOCAL
  31   2-Chloro nitro benzene (CNB)                             0       992.2   LOCAL
  32   2-butanol                                                0     21648.4   LOCAL
  33   2-Phenylethyl amine (PEA)                                0        300    LOCAL
  34   4-Hydroxy Benzaldehyde                             7285.97     9107.47   IMPORT
  35   4-Amino-5-Chloro-2,1,3-Benzothiadiazole             180.79       723.2   LOCAL

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                                    Page 36
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  36   5,6-Dimethoxy-1-Indanone                      80.39       502.45   LOCAL
  37   5-Chloro Acetyl Salicylamide (5-CAS)        7234.84      7234.84   LOCAL
  38   5-Acetonyl-2-Methoxy Benzene Sulfonamide      58.42       2921.1   LOCAL
  39   5% Platinum on Carbon (Type 18K Paste)         2.60        129.8   LOCAL
  40   4-Amino-6-Chloro-1,3-Benzene               73972.60    160273.97   LOCAL
  41   4-Trifluoromethyl Aniline (ForTRF)                0        457.4   IMPORT
  42   4-hydroxycoumarin                                 0                LOCAL
  43   4-(4-aminophenyl) morpholine-3-one                0       1367.4   LOCAL
  44   Acetaldehyde                               535509.1    497685.18   LOCAL
  45   Acetone                                      101100       220316   IMPORT
                                                                          80 %
                                                                          LOCAL 20
                                                                          %
  46 Acetonitrile                                     495        50471    LOCAL
  47 7-Hydroxy-3,4-Dihydrocarbostyril               294.12       735.29   LOCAL
  48 Acetice acid                                        0        57.75   LOCAL
       6-Fluoro-3-piperidino-1,2-benzisoxazole
  49   hydrochloride (FBIP. HCL)                          0       677.5   IMPROT
  50   Acetic Anhydride                                   0      1140.5   LOCAL
  51   5-Methylisoxazole-4-carboxylic acid                0       328.0   IMPORT
  52   5-chlorothiophene-2-carboxylic acid                0       813.3   LOCAL
  53   Activated Charcoal (Neutral)                  12461      85084.0   LOCAL
  54    Alcohol with 5% Acetone                     993.89     24847.32   LOCAL
  55   Acetyl Chloride                                    0    67769.90   LOCAL
  56   Amberlyst-15 (Cation Exchange Resin )       6338.80      7923.50   IMPORT
  57   AMB-I                                      21717.00     12271.00   INHOUSE
  58   Ammonium Thiocyanate                            376       992.00   LOCAL
  59   AML-II                                     22717.39     12494.57   INHOUSE
  60   Aluminium Oxide Neutral                         643      4020.00   LOCAL
  61   Ammonium Chloride                               537     13439.00   LOCAL
  62   Ammonium carbamate                             18.22      910.74   LOCAL
  63   Aluminium Chloride Anhydrous                       0   117352.25   LOCAL
  64   AlFuzsoin Hydrochloride                            0       660.8   LOCAL
  65   Aqueous Monomethylamine (40%) (AMA)          140832     79583.00   LOCAL
  66   Anhydrous Sodium Bicarbonate                    578                LOCAL
  67   Anhdyrous Sodium Carbonate                         9     4047.00   LOCAL
  68   Anhydrous Sodium Bicarbonate                 570.31      2214.90   LOCAL
  69   Anhydrous Sodium Sulphate                      64.16     3153.60   LOCAL
  70   APX-I                                              0      1688.5   INHOUSE
  71   APX-II                                             0      1213.1   INHOUSE
  72   Aripiprazole Stage-I                         391.18       977.94   INHOUSE
  73   Aripiprazole Stage-II (Crude)                587.50      1468.75   INHOUSE

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                              Page 37
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 74   BCL-I                                              0       1344.4   INHOUSE
 75   BCL-II                                             0       645.31   INHOUSE
 76   BDCP                                               0        759.5   INHOUSE
 77   Bendro Amide                                 1714.29      1714.29   LOCAL
 78   Bendroflumethiazide Crude (BNZ-Stage I)      2666.67      2666.67   LOCAL
 79   Benzene Sulphonic Acid                       8804.35      4842.39   LOCAL
 80   BFU-I                                        6338.80      7923.50   INHOUSE
 81   BFU -II                                      7992.71      9990.89   INHOUSE
 82   Benzeneamine derivative                        38.46       1923.1   LOCAL
 83   Benzoic acid                                   14.00        700.0   LOCAL
 84   beta picoline                                      0       455.38   LOCAL
 85   Benzoyl Chloride                              641.00      2015.50   LOCAL
 86   Bisoprolol Fumarate (BFU-III)(Crude) EU      9500.91     11876.14   LOCAL
 87   Bis(2-chloro ethyl) amine hydrochloride            0        940.8   LOCAL
 88   Boron Trifluoride Etherate                    751.94      3842.80   LOCAL
 89   Brimonidine Tartarate Stage I                  55.37        55.37   INHOUSE
 90   Brimonidine Tartarate Stage II                 34.92        34.92   INHOUSE
 91   Brimonidine Tartarate StageIII                 34.92        34.92   INHOUSE
 92   Brimonidine Tartarate StageIV                  33.16        33.16   INHOUSE
 93   Bromobenzene                                  634.53       634.53   LOCAL
 94   Brimonidine Tartarate Stage - V                19.41        19.41   INHOUSE
 95   Brimonidine Tartarate Stage VI                 14.92        14.92   INHOUSE
 96   Buprenorphine Hydrochloride Stage-II          194.50      4862.42   INHOUSE
 97   Buprenorphine Hydrochloride Stage-III         171.14      4278.52   INHOUSE
 98   Buprenorphine Hydrochloride Stage-V            61.61      1540.27   INHOUSE
 99   Buprenorphine Hydrochloride Stage-VI           53.89      1347.32   INHOUSE
100   Buprenorphine Hydrochloride Stage-VII          42.62      1065.44   INHOUSE
101   Buprenorphine Hydrochloride Stage-VIII         37.52       937.92   INHOUSE
102   Buprenorphine Hydrochloride Stage-IX           26.64       666.11   INHOUSE
103   Butylated Hydroxytoluene (BHT)                 17.00        45.00   LOCAL
104   Calcium Chloride                               61.58      1088.42   LOCAL
105   Caustic Lye-46%                           1274893.00   1273758.00   LOCAL
106   Cetrimide                                      54.76       135.10   LOCAL
107   Chloroacetyl chloride (CAC)                        0        554.3   LOCAL
108   Chloroform                                  65733.00    140511.00   LOCAL
109   Citric Acid Monohydrate                            0        463.8   LOCAL
110   Clonidine Hydrochloride Stage-I               493.85       987.70   INHOUSE
111   Clonidine Hydrochloride Stage-II              469.07       938.13   INHOUSE
112   Conc. Nitric Acid                          446589.88    415046.29   LOCAL
113   Conc.HCL                                       39.22      4146.74   LOCAL
114   Conc.Hydrochloric acid                             0      1124.14   LOCAL

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115   Cyanogen Bromide                             22.15      553.69   LOCAL
116   Cyclohexane                                 219.19     5479.87   LOCAL
117   Cyclopropyl Methyl Bromide                   16.71      417.79   IMPORT
118   Cyclopropyl-2-fluorobenzylketone                 0       992.1   LOCAL
119   D (-) Mandelic Acid                          16.88       843.9   LOCAL
120   D(-) Tartaric acid                               0        370    IMPORT
121   Denatured Ethyl Alcohol                    1143.62    28590.60   LOCAL
122   Denatured Ethyl Alcohol with 5% Acetone    1534.90    38372.48   LOCAL
123   Di Isopropyl Ether                         2161.57     13509.8   LOCAL
124   Diazo bicyclo Undacane                           0       518.3   LOCAL
125   Diazo Bicyclo Undacane (DBU)                     0       332.6   LOCAL
126   Diethylene Glycol                          1390.20    34755.03   LOCAL
127   Dimethyl Sulphate                           560.56      1412.6   LOCAL
128   Diisopropylamine                            289.95      1159.8   LOCAL
129   Dimethyl Glutarate                               0    67769.90   IMPORT
130   Dimethyl formamide                               0     10704.9   LOCAL
131   Donepezil Hydrochloride Stage-I             140.71      879.41   INHOUSE
132   Donepezil Hydrochloride Stage-II            120.63      753.92   INHOUSE
133   Donepezil Hydrochloride Stage-III           108.78      679.90   INHOUSE
134   DMN -IV                                      77.24     1544.72   LOCAL
135   Epichlorohydrine                          25355.19    31693.99   IMPORT
                                                                       80 %&
                                                                       LOCAL 20
                                                                       %
136   EDPTSA SALT                                1516.08     3742.00   LOCAL
137   DXZ-I                                            0      1025.3   INHOUSE
138   D-Tryptophan methyl ester hcl (DTME)             0       833.3   IMPORT
139   Ethanol (for TNL)                                0      4234.1   LOCAL
140   Ethanol Anhydrous                         78122.06    162358.0   LOCAL
141   Ether (Diethyl Ether)                       768.72    19218.12   LOCAL
142   Ethyl Acetate                             14899.25    376151.0   LOCAL
143   Ethyl Acetate (Hyflow Preparation )         733.33    14666.67   LOCAL
144   Ethyl Acetoacetate                           25.31     1265.21   LOCAL
145   Ethyl chloroformate                              0        595    LOCAL
146   Ethyl cyano acetate (ECA)                        0       659.9   LOCAL
      ETHYL-3-AMINO CROTONATE (FOR
147   LACIDIPINE)                                  21.51     1075.36   LOCAL
148   Ethylene Diamine                            647.31     1555.90   LOCAL
149   Ethylene Oxide                            420312.5   390625.00   LOCAL
150   Fluorobenzene                                    0   344302.60   LOCAL
151   Formic Acid 99%                               7.91      395.46   LOCAL
152   Fumaric acid                               1623.85     2217.64   IMPORT

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                           Page 39
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153   Glacial Acetic Acid                     597781.00     623816.00   LOCAL
154   Glacial Acetic Acid (21.0-31.5 KG )        148.31         593.2   LOCAL
155   Glyoxal 40%                             1731064.3    1608796.29   LOCAL
156   Glyoxal Sodium Bisulphite                  124.23        124.23   LOCAL
157   Hydrazonyl Chloride                              0       1770.5   LOCAL
158   Hydrobromic Acid                          1654.64        9096.4   LOCAL
159   Hydrochloric Acid (Commercial)           42045.95     284681.11   LOCAL
160   Hydrochlorothiazide Crude (HCT-I)        72945.21     158047.95   INHOUSE
161   Hydrogen Gas                               108.39       2164.51   LOCAL
162   Hydroquinone                                  7.87         15.1   LOCAL
163   Hyflow Supercell                           3892.6      12676.23   LOCAL
164   Iodine Crystals                               0.43        10.74   LOCAL
165   Isopropyl Alcohol                          398237        267584   LOCAL
166   Isoamyl Alcohol                           5005.43      10010.85   LOCAL
167   Isopropanolic HCl (25%) (IPA.HCl)             99.2       3757.7   LOCAL
168   Isopropyl Amine                          16626.59      20783.24   LOCAL
169   Keto acid (KTD-I)                                0     44917.26   INHOUSE
170   Keto Acid Stage-II                               0     80000.00   INHOUSE
171   KSM-I                                            0       1131.2   INHOUSE
172    L (+) Tartaric acid                       144.59       1700.32   LOCAL
173   LABETALOL HYDROCHLORIDE (LBL-I)           7596.59       7596.59   INHOUSE
174   LABETALOL HYDROCHLORIDE (LBL-II)          6190.86       6190.86   INHOUSE
175   Lacidipine Stage-I (Br-DHP)                  18.12       906.21   INHOUSE
176   Lacidipine Stage-II                          10.87       543.34   INHOUSE
177   Liquid Bromine                               38.44        38.44   LOCAL
178   Liquor Ammonia (25%)                   6491579.00    6073924.00   LOCAL
179   Magnesium Turnings                           39.36       984.06   LOCAL
180   Maleic acid                                875.27        583.51   LOCAL
181   malonic acid                                     0      1100.69   LOCAL
182   MDC                                              0     16993.00   LOCAL
183   Metane sulphonic acid                            0        251.9   LOCAL
184   Methanolic Ammonia                               0      13819.7   LOCAL
185   Methelene chloride                          14318     533057.00   LOCAL
186   Methyl benzothiazine Isopropyl Ester      5551.86      14106.00   LOCAL
187   Metronidazole (Crude) Stage-I           358666.67     333333.33   INHOUSE
188   MNI Crude Stage-III (DRY)               747222.22     694444.44   INHOUSE
189   Morpholine Dilactam                              0       1639.3   LOCAL
190   MTZ-II                                  286933.33     266666.67   INHOUSE
191   MTZ-III                                    269000     250000.00   INHOUSE
192   MXM-I                                     5884.31      14122.34   INHOUSE
193   N,N-Dimethylformamide                       20117      28559.46   LOCAL

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194   N.N-Dimethyl-4-Aminobutanal Diethyl Acet        107.9      3110.90    LOCAL
195   N-Benzylpiperidine-4-Carboxaldehyde            100.47       627.94    LOCAL
196   N-Bromosuccinimide                                  0       1091.3    LOCAL
197   n-Butanol                                           0     24020.00    LOCAL
198   Neutral Alumina                               7992.71      9990.89    LOCAL
199   n-Heptane                                      551.55       2206.2    LOCAL
200   n-Hexane (Petroleum Fraction)                 5271.00     33133.00    LOCAL
201   Nitrogen Gas                                  1352.00     41298.00    LOCAL
202   Nitromethane                                        0       3065.2    LOCAL
203   Oleum 65%                                  1855601.85   1724537.03    LOCAL
204   O-Xylene                                     33204.79     88721.00    LOCAL
205   Palladium Acetate                                0.36        18.11    LOCAL
206   Palladium on Carbon - 5%                         2.42        53.90    LOCAL
207   Paraformaldehyde                              8835.62     19143.84    LOCAL
208   Perchloric acid 70%                                 0       1642.1    LOCAL
209   Phenylacetaldehyde Dimethylacetal             1485.71      1485.71    LOCAL
210   Phosphorus Oxychloride                              0          570    LOCAL
211   Phosphorus Pentoxide (P2O5)                         0          270    LOCAL
212   Phthaloyl Amlodipine                           31214        17639     LOCAL
213   piperidine                                          0       138.44    LOCAL
214   Piperonal (PPN)                                     0        521.0    LOCAL
215   Piroxicam crude (PRC-I)                             0        703.7    INHOUSE
216   PLP-I                                               0        609.8    INHOUSE
217   Polyethylene Glycol 400                        360.29       900.74    LOCAL
218   Potassium Carbonate                              911        9741.0    LOCAL
219   Potassium Hydroxide                            116.78       4062.0    LOCAL
220   Potassium Iodide                                 1.69        175.5    LOCAL
221    Pra chloro benzaldehyde                            0     1144.167    LOCAL
222   Pramipexole Stage-I (PRM-I)                     21.63       432.52    INHOUSE
223   Pramipexole Stage-II                            22.68       453.66    INHOUSE
224   Pramipexole Stage-III                           15.85       317.07    INHOUSE
225   Pramipexole Stage-IV                            11.14       222.76    INHOUSE
226   Propionic Anhydride                             16.67       333.33    LOCAL
227   PRS-I                                               0       1388.9    INHOUSE
228   PRS-II                                              0        625.4    INHOUSE
229   PRS-III for seeding                                 0           1.6   INHOUSE
230   p-Toluene Sulphonic Acid                       1879.7       4642.2    LOCAL
231   Pure 2-Isopropoxy Ethanol                    87333.33    109166.67    LOCAL
232   Raney Nikel Catylst                                 0        458.0    LOCAL
233   Rivaroxaban Stage I (RVR-I)                         0       2359.1    INHOUSE
234   Rivaroxaban Stage II (RVR-II)                       0       1946.5    INHOUSE

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235   Rivaroxaban Stage III (RVR-III)                    0      1367.4   INHOUSE
236   Rivaroxaban Stage IV (RVR-IV)                      0      1332.9   INHOUSE
237   Rizatriptan benzoate crude (RZT-I)             15.38       769.2   INHOUSE
238   Silica gel                                       488     23607.0   LOCAL
239   Sodium Acetate Trihydrate                      51.01       51.01   LOCAL
240    Sodium Bicarbonate                             9.93       347.6   LOCAL
241   Sodium Bisulphate                                  0       492.7   LOCAL
242   Sodium Borohydride                           2205.39      3115.0   LOCAL
243   Sodium Chloride                              6491.00     21997.0   LOCAL
244   Sodium dithionite                                  0       38.90   LOCAL
245   Sodium Hydroxide                            15025.00     25042.0   LOCAL
246   Sodium Iodide                                 289.71      724.26   LOCAL
247   Sodium Methoxide (Solid)                       26.12       272.3   LOCAL
248   Sodium Nitrite                                 32.45      967.55   LOCAL
249   Sodium Sulphite                                69.62      3480.8   LOCAL
250   Sodium Thiosulphate Pentahydrate                   0        61.9   LOCAL
251   Sodium Triacetoxy borohydride                      0       520.8   LOCAL
252   Stannous Chloride Dihydrate                   183.20     1831.98   LOCAL
253   Succinic acid                                      0          98   LOCAL
254   Sulphuric Acid - 97%                         1579836   1510752.0   LOCAL
255   Tadalafil (TDL-I)                                          1000    INHOUSE
256   Tamsulosin Hydrochloride Stage-I               55.18      2758.8   INHOUSE
      Tamsulosin Hydrochloride Stage-II For
257   seeding                                         0.32        16.2   INHOUSE
258   Tamsulosin Hydrochloride Stage-II              38.95      1947.4   INHOUSE
259   Tamsulosin Hydrochloride Stage-III             22.69     1134.50   INHOUSE
260   TEA                                                0      1770.5   LOCAL
261   Teneligliptin Hydrobromide Pure (TNL-II)           0         1.0   INHOUSE
262   Teneligliptin Hydrobromide Crude (TNL-I)           0        625    INHOUSE
263   Tert Butyl Chloride                           195.10     4877.52   LOCAL
264   Terta Butyl Acrylate                           15.85      792.37   LOCAL
265   Tertiary Butyl Alcohol                        189.46      189.46   LOCAL
266   Tetrabutyl ammonium bromide                        0        40.0   LOCAL
267   Tetra-Butyl Ammonium Hydrogen Sulphate          7.82        7.82   LOCAL
268   Tetrahydrofuran                            350090.00   901659.00   LOCAL
269   TFC-I                                              0      1018.1   INHOUSE
270   Thebain                                       201.34     5033.56   LOCAL
271   Thebaine - Pure                               185.23     4630.87   LOCAL
272   Thionyl Chloride                              103.09     1639.30   LOCAL
273   Tizanidine Base Crude (TIZ-STAGE III)         112.99       452.0   INHOUSE
274   Tizanidine Base -Pure (TIZ-STAGE IV)           62.15       248.6   INHOUSE
275   Tizanidine Hydrochloride Stage-I              192.09       768.4   INHOUSE

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276   Tizanidine Hydrochloride Stage-II      158.19      632.8   INHOUSE
277   TLT-I                                  207.86      831.4   INHOUSE
278   TLT-II                                 228.61      914.4   INHOUSE
279   TLT-III                                175.39      701.5   INHOUSE
280   TNL Piperazine derivative                   0      297.6   LOCAL
281   TNL Pyrrolidine derivative                  0      386.9   LOCAL
282   Tofacitinib Citrate - II (TFC - II)         0     1131.2   INHOUSE
283   Tofacitinib citrate - III (TFC-III)         0      678.7   INHOUSE
284   Tofacitinib Citrate - IV (TFC-IV)           0      356.7   INHOUSE
285   Tofacitinib citrate - V (TFC- V)            0      588.2   INHOUSE
286   Toluene                                84042    182665.0   LOCAL
287   Tributyl Amine                          17.02     851.23   LOCAL
288   Triethylamine                           15.85     2337.0   LOCAL
289   Trifluoroacetic Acid                    15.39     769.73   LOCAL
290   Trimethyl Orthoformate                      0     270.61   LOCAL
291   Triphenyl Phosphine                      1.81      90.56   LOCAL
292   Triphosgene                                 0      781.2   LOCAL
293   TXS Stage-I(IDN 6116)                       0      339.5   INHOUSE
294   TXS Stage-II (IDN 6007)                     0      384.6   INHOUSE
295   TXS Stage-VI                                0      261.6   INHOUSE
296   Vortioxetine hydrobromide Stage-I           0     1262.0   INHOUSE
297   Vortioxetine hydrobromide Stage-II          0     1009.6   INHOUSE
298   Vortioxetine hydrobromide Stage-III         0      833.3   INHOUSE

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                    Page 43
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                                     Annexure IV-Plot layout

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                                     Annexure V: valid CTO

M/s. Sadekar Enviro Engineers Pvt. Ltd.                                     Page 45
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M/s. Sadekar Enviro Engineers Pvt. Ltd.                           Page 55
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                                Annexure VI: CTO prior to 2006

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M/s. Sadekar Enviro Engineers Pvt. Ltd.                           Page 60
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