Brief Summary of Project

Harman Finochem Ltd. is planning to set up a new API manufacturing facility at Plot No. N-24 at Additional Industrial Area, Patalganga Taluka , Dist. Raigad . It is proposed to manufacture 17 products totaling 157.93 MT/Month as per details provided in Chapter 3 in section 3.5. This level of production will not be commenced from day one, but will commission smoothly.

The notification number S. O. 1533 promulgated on 14th September 2006 has covered these types of industries under its entry 5(f). It is stated that Synthetic Organic Chemical Industry (Bulk Drugs & Intermediates) located in a notified industrial area comes under category B. This is located notified industrial zone of MIDC Maharashtra Industrial Development Corporation. However the notification has not stated any exemption lower limit for the entry.

As such, with screening it is necessary for HFL, to approach State Experts Appraisal committee (SEAC), , Delegated Authority from Ministry of Environment and Forest (MoEF), New Delhi for environment clearance. The pre-feasibility report however is prepared for forming a framework for EIA study, scoping and finalizing the terms of Reference, as may be required.

Justification

The public health is one of the prime considerations of the government. Large funds are generally allocated to this account head in every annual budget of the State and Centre. By these Government efforts India has found an excellent outcome of lowering the death rate at birth and increasing the general length of life. The credit goes to purchasing power and also to availability of proper medicines. Indian chemical engineers are well respected in the world and the quality of their products.

Though many traditional disease and disorders are controlled or even eradicated, we are finding that due to change in way of life, never ailments are prevailing

HFL has developed these products by in-house trials, and are desirous to serve the nation by producing it here, albeit in a small scale. The proponents are very sure to receive recognition from University, National laboratories and Administration of Developed nations especially USFDA.

Justification of this project can be submitted on other ways as namely-

How this project is economically strong?

How the wastage is prevented?

How the pollution generated from this unit can be successfully management through EMP implementation?

With lower pollution potential also, this industry has a justification.

Sensitivity

Any proposed human activity is never a simple straight forward mater. When production is done, the side effect of pollution takes place through the degree may vary as per alertness of the project proponent. There are many facets of environment and which is more sensitive depends both on the industrial process involved as well as on the location characteristics. This must be considered in that hierarchy and is so considered during the scoping exercise in this particular case.

However, proponent has thoroughly examined this and has self prescribed many conditions. In this project, air component has a limited role to play as no raw material is gaseous in nature. Only Fuel in DG sets & boiler and their emissions will be participating for air pollution. The stack shall be provided as per MPCB consent conditions and monitoring platforms as per CPCB norms. Fugitive emissions shall be controlled by smooth road surfaces, closed circuit transfers, negative pressure in reactors and tree plantations. There shall be some emissions from process in the form of VOC, Acid fumes, Ammonia, SO2, Bromine etc. from various reactions and solvent handling, reactions etc. proper condensation system shall be provided to arrest the same.

To maximum extent solid waste needs attention, as it is Pharmaceutical unit, there will be hazardous waste generating like waste lubricants, solvent distillates, process residues, spent catalyst, spent mother liquor, discarded containers etc. this will be carefully stored in barrels or bins as per norms. This will be stored under roof with parapet and on raised platform. Nothing is stored for more than one month. This will be sent to Common Hazardous Waste Storage Treatment and Disposal Facility CHWTSDF at Taloja Navi Mumbai. Regular manifest system will be followed while sending the Hazardous Waste to the facility. Recycling and reuse will be done in case of Non Hazardous solid waste.

There will be no nuisance from noise. DG set will be run occasionally only for backup power supply during power failure. In this case majority input is odorless and only few with mild or characteristic odor. This will be handled carefully. No nuisance will go to surrounding industries.

3. Location

The government has a desire to improve status of this region and hence also encouraged MIDC industrial area at addl. Patalganaga. In order to have a sustainable development, the pollution generation from this industry is finally made insignificant having taken all the precautions right from raw material selection up to low or no waste generation and conversion.

The proposed project is on Plot No. N- 24 in Notified Industrial Area, MIDC, Patalganga Dist. Raigad, in Maharashtra. The geographical location of this industry is 180 52’16.57’’ N and 730 09’ 57.06’’ E with an elevation of 54ft ( 17 m.) above mean sea level (MSL). Government MIDC has provided all infrastructure like assured Electrical power, continuous water supply with purification from water works having RSF Rapid Sand Filtration and disinfection, the internal road network, external approach road and networking with CHWTSDF (Common Hazardous Waste Storage Treatment and Disposal) facility at Taloja, Navi Mumbai, Maharashtra state.

The proposed land is on Plot No. N-24 admeasuring 20,066 sq. mtrs.

List of Proposed products and Production Capacity

Sr. Product Categories Production Medicinal Use No. Quantity (MT/ Month) 1 Allopurinol 10.00 Anti Gout 2 Bisoprolol Hemifumerate 24.00 Antihypertensive 3 Chlorpheniramine Maleate 15.00 Antihistamatic 4 Divalporex Sodium 15.00 Central Nervous Stimulant 5 Fenofibrate 10.00 Lipid Regulating Drug 6 Ketamine Hydrochloride 0.83 Anesthetic 7 Lidocaine Base 10.00 Anesthetic 8 Lidocaine Hydrochloride 12.00 Anesthetic 9 Methylcobalamin 0.10 Vitamin 10 Phenytoin 10.00 Central Nervous Stimulant 11 Phenytoin Sodium 15.00 Central Nervous Stimulant 12 Propofol 8.00 Anesthetic 13 Salbutamol Sulphate 5.00 Adrenergics/ Inhalants 14 Sitagliptin Phosphate Anhydrous 2.00 Anti-Diabetic 15 Sitagliptin Phosphate Monohydrate 2.00 Anti-Diabetic 16 Valproic Acid 7.00 Central Nervous Stimulant 17 Valsartan 12.00 Antihypertensive

Total 157.93

List of Raw Materials

Sr. Name of Raw Material Category Approx. raw Solid/Liquid material No req./ton 1. Allopurinol 1 Cyanoacetamide Reactant 184.80 Solid 2 Triethyl orthoformate Reactant 358.51 Liquid 3 Morpholine Reactant 222.18 Liquid 4 CMA Solvent Solvent 87.12 Liquid 5 Hydrazine Hydrate Reactant 89.76 Liquid 6 Sulphuric acid Reactant 205.92 Liquid 7 Formamide Reactant+Solvent 741.84 Liquid 8 Liquor Ammonia Work up 221.76 Liquid 9 Catalyst 8.98 Solid Activated carbon 10 Hyflosupercel Filtration Aid 0.53 Solid 2. Bisoprolol Hemifumerate 1 Parahydroxy benzyl alcohol Reactant 1.0 Liquid 2 2-Isopropoxy ethanol Solvent 19 Liquid 3 Amberlyst -15 Reactant 1.0 4 Pottassium Carbonate Reactant 0.100 Solid 5 Chloroform Reactant 2.040 Liquid 6 Sodium Sulphate Anhydrous Reactant 0.100 Solid 7 Hyflosupercel Filtration Media 2.000 Solid 8 Epichlorohydrine Reactant 2.590 Liquid 9 Sodium Hydroxide Flakes Reactant 0.190 Solid 10 Methanol Solvent 12.0 Liquid 11 Monoisopropyl Amine Reactant 0.760 Solid 12 Acetone Solvent 20.200 Liquid 13 Fumaric Acid Work Up 0.200 Liquid 14 Activated Carbon Catalyst 0.050 Solid 3. Chlorpheniramine Maleate 1 2-(4- Chlorobenzyl) pyridine Reactant 1052.63 Liquid 2 2- chloro-N-N- Reactant 578.94 Liquid Dimethylethanamine 3 Sodium Amide Reactant 263.15 Solid 4 Ethyl Acetate Reactant 10526.31 Liquid 5 Malic Acid Work Up 547.36 Liquid 6 Ammonia Solution Work Up 1578.94 Liquid 4. Divalporex Sodium 1 Valproic acid Reactant 230.40 Liquid 2 Sodium hydroxide Reactant 32.25 Solid 3 Methanol Solvent 552.96 Liquid 4 Activated carbon Catalyst 1.92 Solid 5 Hyflosupercel Filtration Media 0.77 Solid 5. Fenofibrate 1 Fenofibric Acid Reactant 31.32 Solid 2 Sodium Hydroxide Reactant 4.5 Solid 3 Isopropyl Alcohol Solvent 234.72 Liquid 4 Methanol Solvent 198 Liquid 5 Ethyl Acetate Reactant 27.86 Liquid 6 Hyflo Super Cell Filtration Media 7.2 Solid 6 Ketamine Hydrochloride 1 Cyclopentyl chloride Reactant 1333.33 Solid 2 Diethyl Ether Reactant 2133.33 Liquid 3 O-chlorobenzonitrile Reactant 1306.66 Solid 4 Toluene Solvent 11440 Liquid 5 Magnesium Catalyst 312 Solid 6 Hydrochloric acid Work Up 2933 Liquid 7 Sulfuric acid Work Up 4533 Liquid 8 Bromine Reactant 1160 Liquid 9 Methanol Solvent 5866 Liquid 10 Potassium hydroxide Reactant 600 Solid 11 Sodium sulfate Reactant 266.66 Solid 12 Dekaline Reactant 4000 Solid 13 Acetone Solvent 1333.33 Liquid 14 Activated carbon Catalyst 80 Solid 15 Hyflow Filtration media 106.66 Solid 16 Ammonia Work Up 666.66 Liquid 17 Isopropyl alcohol Solvent 3066 Liquid 18 Isopropyl alcohol HCL Work Up 800 Liquid 19 Monomethyl amine Reactant 2133 Liquid 7 Lidocaine Base 1 2,6-Xylidine Reactant 7.20 Liquid 2 Chloroacetyl chloride Reactant 7.34 Liquid 3 Sodium carbonate Work-up 7.20 Solid 4 Toluene Solvent 12.45 Liquid 5 Diethylamine Reactant 5.18 Liquid 6 Sodium carbonate Work-up 6.55 Solid 7 Acetone Solvent 53.64 Liquid 8 Activated carbon Catalyst 0.22 Solid 9 Hyflow supercell Filtration Media 0.43 Solid 8 Lidocaine Hydrochloride 1 2,6-Xylidine Reactant 7.20 Liquid 2 Chloroacetyl chloride Reactant 7.34 Liquid 3 Sodium carbonate Work-up 7.20 Solid 4 Toluene Solvent 12.45 Liquid 5 Diethylamine Reactant 5.18 Liquid 6 Sodium carbonate Work-up 6.55 Solid 7 Acetone Solvent 53.64 Liquid 8 Hydrochloric acid Work-up 4.68 Liquid 9 Activated carbon Catalyst 0.22 Solid 10 Hyflow supercell Filtration Media 0.43 Solid

9 Methylcobalamin 1 Cyanocobalamin Reactant 0.119 Solid 2 Cobalt Chloride(II) hexahyrate Reactant 0.007 Solid 3 Dimethyl Carbonate Reactant 79.16 Solid 4 Sodium Borohydride Reactant 50.00 Solid 5 Sodium Hydroxide Reactant 5.00 Solid 6 Acetone Solvent 2380 Liquid 7 Resin Filtration Media 5952 Solid 10 Phenytoin 1 Benzil Reactant 57.60 Solid 2 Urea Reactant 29.26 Solid 3 Caustic Lye Reactant 60.00 Liquid 4 Methanol Solvent 57.60 Liquid 5 Hydrochloric Acid Work up 152.32 Liquid 6 Hyflosupercel Filtration Aid 0.77 Solid 7 Activated carbon catalyst 0.77 Solid 11. Phenytoin Sodium 1 Benzil Reactant 75.60 Solid 2 Methanol Solvent 75.60 Liquid 3 Caustic lye Reactant 6156.00 Liquid 4 Urea Reactant 38.40 Solid 5 Hydrochloric acid Work up 149.94 Liquid 6 Activated carbon Catalyst 2.02 Solid 7 Hyflosupercel Filtration Media 2.02 Solid 12. Propofol 1 p-hyroxy Benzoic acid Reactant 60 Solid 2 Isopropyl Alcohol Solvent 78.23 Liquid 3 Caustic Lye Work up 7208 Liquid 4 Conc. Sulphuric acid Work up 397.2 Liquid 5 Toluene Solvent 309.6 Liquid 6 HCl (30%) Work up 208.8 Liquid 7 Methanol Solvent 173.33 Liquid 8 Activated Carbon Catalyst 1.2 Solid 9 Hyflosupercel Filtration media 30 Solid 10 Ethylene glycol Reactant 99.6 Liquid 13 Salbutamol Sulphate 1 Salicyclic Acid Work up 2.73 Liquid 3 Sulphuric Acid Work Up 1415.38 Liquid 4 Sodium Bicarbonate Reactant 615.38 Solid 5 Ethyal Acetate Solvent 6923 Liquid 6 Anhydrous Aluminium Chloride Work Up 2307 Solid 7 Acetyl Chloride Reactant 1000 Liquid 8 Methylene Di chloride Solvent 18523 Liquid 9 Conc. Hydrochloric Acid Work Up 2215 Liquid 10 Iso Propyl Alcohol Solvent 3646 Liquid 11 Benzyl Chloride Reactant 1077 Solid 12 Pottassium Carbonate Reactant 877 Solid 13 Potassium Iodide Reactant 123 Solid 14 Liquid Ammonia Reactant 2000 Liquid 15 Dimethyl Formamide Solvent 3615 Liquid 16 Selenium Oxide Work Up 1476 Solid 17 1,4- dioxane Reactant 11892 Solid 18 Tetra Hydro Furaone Work Up 17123 Liquid 19 Tetra Butyl Amine Reactant 1953.84 Solid 20 Zinc Chloride Reactant 476.92 Solid 21 Sodium Borohydride Reactant 815.38 Solid 22 Ethyl Acetate Solvent 4923.07 Liquid 14. Sitagliptin Phosphate Anhydrous 1 Boc- Butanoic Acid Reactant 12.36 Solid 2 Pyrazine Hydrochloride Reactant 9.32 Solid 3 Dicyclohexyl Carbodimide Reactant 8.412 Solid 4 1- Hydroxybenzotriazole Reactant 5.496 Solid 5 Triethylamine Reactant 8.244 Liquid 6 Methylene Dichloride Reactant 608.16 Liquid 7 Sodium Bicarbonate Reactant 2.22 Solid 8 Methanolic HCl (13-17%) Reactant 49.44 Liquid 9 Sodium Hydroxide Reactant 7.908 Solid 10 Sodium Chloride Reactant 3.084 Solid 11 Activated Carbon Catalyst 0.612 Solid 12 Hyflow Super Cell Filtration Media 1.236 Solid 13 Ortho- Phosphoric Acid Reactant 3.36 Liquid 14 Isopropyl Alcohol Solvent 14.4 Liquid 15 Heptane Reactant 95.16 Liquid 15 Sitagliptin Phosphate Monohydrate 1 Boc- Butanoic Acid Reactant 12.36 Solid 2 Pyrazine Hydrochloride Reactant 9.324 Solid 3 Dicyclohexyl Carbodimide Reactant 8.412 Solid 4 1- Hydroxybenzotriazole Reactant 5.496 Solid 5 Triethylamine Reactant 8.244 Liquid 6 Methylene Dichloride Reactant 608.16 Liquid 7 Sodium Bicarbonate Reactant 2.22 Solid 8 Methanolic HCl (13-17%) Reactant 49.44 Liquid 9 Sodium Hydroxide Reactant 7.90 Solid 10 Sodium Chloride Reactant 3.08 Solid 11 Activated Carbon Catalyst 0.612 Solid 12 Hyflow Super Cell Filtration Media 1.236 Solid 13 Ortho- Phosphoric Acid Reactant 3.36 Liquid 14 Isopropyl Alcohol Solvent 14.4 Liquid 15 Heptane Reactant 95.16 Liquid 16 Valproic Acid 1 Di ethyl di propyl malonate Reactant 2.00 Liquid 2 Caustic Flakes Reactant 1660 Solid 3 Methanol Solvent 812 Liquid 4 Hydrochloric Acid Work Up 4620 Liquid 17 Valsartan 1 L- Valine Reactant 76.8 Solid 2 Thionyl Chloride Reactant 115.2 Liquid 3 Methanol Solvent 303.360 Liquid 4 4- (Bromomethyl) biphenyl- Reactant 145.920 Liquid 2- Carbonitrile 5 Sodium bicarbonate Reactant 207.360 Solid 6 Acetone Solvent 546.048 Liquid 7 Hydrochloric Acid Reactant+Catalyst 192 Liquid 8 Ethyl Acetate Reactant 484.8 Liquid 9 O- Xylene Reactant 1107.84 Liquid 10 Pottassium Carbonate Reactant 55.104 Solid 11 Tributyline Chloride Reactant 346.368 Liquid 12 Valery Chloride Reactant 78.720 Liquid 13 Sodium Azide Reactant 78.720 Solid 14 Sodium Hydroxide Reactant 141.696 Solid 15 Methylene Dichloride Reactant 4851.84 Liquid 16 Sodium Sulphate Reactant 47.04 Solid 17 Activated Carbon Catalyst 14.4 Solid 18 Hyflo Super Cell Filtration Media 9.6 Solid 19 Ethyl Acetate Reactant 1203.84 Liquid 20 Sodium Chloride Reactant 23.616 Solid

Land Form: Land is on plain contour, it is flat terrain.

Land Ownership: Land ownership is with proponents.

Existing Land use Pattern: The land is reserved for industrial use few trees and grasses are present at the site, which will be retained for Landscape Development.

Existing Infrastructure: Presently there is no existing infrastructure at the site. Infrastructure like water, electricity, telephone facility, roads already available, as this is an industrial area.

Other infrastructure like, hospital, school, housing entertainment, daily needs area available easily at a Rasayani village which is 6 km at North East direction from project site.

Domestic Airport located at Santacruz and Chatrapati Shivaji International Airport at which is 75 km from the project site at North East direction. Nearest Railway station is Rasayani which is 6 km from the project area. The site is very well connected by road, air and rail network.

HFL is desirous to establish new unit in this sector with proposing a 157.93 MT/Month product of synthetic organic chemicals required especially by pharmaceuticals. The daily water requirement during construction phase shall be 50 cum/day and the Daily water requirement during operation shall be 440 m3/day. It is proposed to use multifuel boiler (2 Nos) of 5 TPH capacity. The fuel proposed to be used shall be Furnace Oil- 400kgs. /hr. or Coal-650 kgs./hr. or Briquette-800 kgs./hr.

In HFL, safety and occupational health will be dealt carefully. A disciplined approach shall be natural to this industry. Safety policy will be in place. This unit shall be registered under factories act and shall be bounded by State Factory Rules. Thus, first aid trained and fire fighting trained person will be available in every shift. Safely officer will be appointed. Wherever necessary, provisions of other acts will be obeyed. Fire fighting system will be kept as per norms.

DMP (Disaster Management Plan) and off-site emergency plan will be in place. Accordingly, personal protection equipment will be given and use will be insisted. Consulting physician will be retained to attain the factory.

The industry will manufacture synthetic organic Chemicals which are in good demand for growing Medical facilities in India. This will not disturb the present land use because our area occupied will be only small % of influence zone 10 km. this land is in industrial estate. No rehabilitation is involved. There will be no any type of Hazardous or nonhazardous waste materials as all will be disposed as per CPCB norms.