Brief Summary of Project Harman Finochem Ltd. Is Planning to Set Up
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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 Panvel, Dist. Raigad Maharashtra. 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), Mumbai, 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