Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd)

Transcription

1 PRE - FEASIBILITY REPORT For EXPANSION OF EXISTING BULK DRUG & INTERMEDIATES MANUFACTURING UNIT at Survey No: 29, Tupakulagudem (Village), Tallapudi (Mandal), West Godavari (Dist.), Andhra Pradesh By Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) Office address: Duplex No: 29, Lakshmi Gayatri Enclave, Aditya Nagar, KPHB, Kukatpally, Hyderabad November

2 Contents S. No. Description Page no. 1.0 Executive Summary Introduction of the Proposed Project Project Proponent Brief description of the project Need for the project and its importance to the country and or region Demand-Supply Gap Employment Generation(Direct and Indirect) due to the project Project description Product and Production Capacity Raw materials required and Quantities Manufacturing Process Resource Utilize and Recycling Water Power Requirement Fuel Requirement Quantity of wastes generated Waste Water Generation and utilization Solid waste generation and Disposal Schematic representations of the feasibility drawing which give information of EIA purpose Site Analysis Connectivity Land Form, Land use and Land ownership Existing Infrastructure Soil classification Climatic data from secondary sources Social Infrastructure available Planning in brief Proposed infrastructure Industrial Area Residential Area Green Belt Social Infrastructure Water management Sewerage System Industrial Waste Management Rehabilitation and Resettlement (R&R) Plan 17

3 8.0 Project Schedule and Cost estimate Analysis of project 17 LIST OF TABLES Table No Description Page no. 3.1 Proposed Products and Existing Products and their 8-10 Production Capacities 3.2 List of By-Products Water Requirement Details Wastewater generation and Treatment Method Solid and hazardous waste generation and Disposal LIST OF FIGURES Figure No Description Page no. 1.1 Location Map Google Earth Map Showing Tagoor Laboratories Private Limited 7 LIST OF FLOW CHART Flow Chart No 3.1 Description Page no. Generalized Flow Chart for Bulk Drug Manufacturing 11

4 1.0 EXECUTIVE SUMMARY Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) is a partnership firm and it is registered office at Duplex No: 29, Lakshmi Gayatri Enclave, Aditya Nagar, KPHB, Kukatpally, Hyderabad Telangana State. S. No Parameter Description 1 Project Location 2 Category of Project as per EIA Notification & 5(f) A Amendments 3 Project cost 42 Crores Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.), Andhra Pradesh 4 Plot area Acres ( Sq.m) 5 Proposed Products 6 Resources (I)Electricity Requirement 7 Source of electricity D. G. Sets (II)Water consumption Proposed Products List is mentioned in section KVA Andhra Pradesh Southern Power Distribution Company Limited (APSPDCL) Existing: 250 KVA (Continued) Proposed: 500 KVA KL/day 8 Source of water Ground Water Waste water generation (III)Boiler KL/ day Existing: 6.0 TPH Coal fired/ Agro waste fired Boiler, 2,00,000 kcal/hr. Thermo pack Boiler (Continued); Proposed: 4.0 TPH Coal fired/ Agro waste fired Boiler 9 (IV)Fuel Coal Requirement TPD for proposed & Existing boilers and Thermo pack Boiler, 10 Mode of disposal Zero Liquid Discharge System 11 Solid waste generation Mentioned in Para of report 12 Nearest Highway National Highway NH - 16: 26 KMs (SE) (Rajahmundry Anakapalle) 13 Nearest Railway Station Kovvuru Railway station 22.0 KMs (SE) 14 Nearest Airport Rajahmundry Airport KMs (ESE) Page 1

5 2.0 INTRODUCTION OF THE PROJECT The objective of this pre- feasibility study is to provide information on proposed to Expansion of Existing Bulk Drug & Intermediate manufacturing unit of Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) located at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.), Andhra Pradesh. 2.1 Project Proponent Mr. Penmetsa Subramanyam Raju, Managing partner of the company is young and energetic personality with vast experience in pharmaceutical industry Mr. Subramanya Raju has work experience of more than 18 years in bulk drugs industry. He has worked in senior position as Director-manufacturing in Vasudha group of industries and helped to emerge as one of the leading group in bulk drug industry. During his tenure in Vasudha Pharma Chem Limited, he had managed 3 units situated in jeedimetla, kazipally, and Visakhapatnam looking after production, research and development, packing, dispatch of the finished intermediates and APIs at right time, conforming to the specifications. Added to this, he is actively involved in discussing with the customers for extracting business by increasing the yields and reducing production cost to meet the demand of the customers. He has visited many countries in Europe & Asia for exhibiting the bulk drug products. Mr. Subramanyam Raju is also Managing Partner of Sri Venkateswara Industries which manufactures the intermediates & bulk drugs, situated in Hyderabad. Considering his skills and abilities, M/s Shree Jaya Laboratories Pvt Ltd., have offered him the post of Director during February 2012 and he assumed charge of the Director during February 2012 and has taken charge as Chairman during April 2013 looking after the entire production, research and development activities of the organization. He has improved the turnover of the company from 28 crores to 120 crores within a short span of one year. Mr. Subramanyam Raju is experienced in manufacturing, process development, project management, scale up to operations, quality systems and the aqua culturing technically. Page 2

6 Mr. Subramanyam Raju was also awarded Hon. Doctorate by the international university in Colombo during November He has also acquired more than 20acres of land in west Godavari district of Tallapudi Mandal for establishment of Vensar and Vensub laboratories for manufacturing APIs. All the relevant licenses for commencement of the units were obtained and the land is made ready for construction works. Dr. Pericherla Kasiviswanadharaju, the partner of the company is technically qualified person, having rich experience in organic synthesis. He recently finished his Ph. D from prestigious institute BITS Pilani, Rajasthan and his technical background is an additional asset to the industry. Presently, he is involved in purchase, marketing and research and development departments. 2.2 Brief description of the project. Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) is proposed to expansion of Existing Bulk Drug & Intermediate manufacturing unit at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.), Andhra Pradesh. 2.3 Need for the project and its importance to the country and region Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) is proposed to expansion of existing Bulk Drug & Intermediate manufacturing unit at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.), Andhra Pradesh. Availability of the well-connected road and railway network for easy transportation of the construction equipments and materials, Raw materials and finished products. Easy availability of skilled and unskilled labor for construction of Plant and its operation. The Indian pharmaceutical industry currently tops the chart amongst India's sciencebased industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high amongst all the third world countries, in terms of Page 3

7 technology, quality and the vast range of medicines that are manufactured. It ranges from simple headache pills to sophisticated antibiotics and complex cardiac compounds; almost every type of medicine is now made in the Indian pharmaceutical industry. The Indian pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The Pharmaceutical and Chemical industry in India is an extremely fragmented market with severe price competition and government price control The Pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals, and injectibles. There are approximately 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). The Indian pharma industry, which is expected to grow over 16 per cent per annum between 2017 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period!. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated Indian Ambassador to the US. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). India has also maintained its lead over China in pharmaceutical exports with a yearon-year growth of per cent to US$ billion in FY , according to data from the Ministry of Commerce and Industry. Imports of pharmaceutical products rose marginally by 0.80 per cent year-on-year to US$ 1, million. Overall drug approvals given by the US Food and Drug Administration (USFDA) to Indian companies have nearly doubled to 201 in FY from 109 in FY The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ billion US generics market. 2.4 Demand-Supply Gap. There is a quite considerable gap between supply and demand for, fine chemicals, bulk drugs and intermediates. Very few players are in the market who can offer continuous supply. The company wants to bridge this gap between demand and supply by expanding the production capacity and thereby, making good business. Page 4

8 Company's marketing edge comes from its direct and close contact with the customers. Their products are major strength of their customers. Each stage of their product is been monitored /checked for their quality to ensure quality product reaches their customer. They plan to launch new products every year to satisfy the need of their customers as per the market demand. 2.5 Employment Generation (Direct and Indirect) due to the project Approximate employment generation due to proposed unit is 118. Apart from this there will be significant non estimated employment generation at the supplier firms and service industry providing services to the company. Company shall be giving preference to people from economically weaker sections for employment in various semi-skilled/unskilled jobs thereby contributing to their upliftment. 3.0 Project Description Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) is proposing the Expansion of existing Bulk Drug and Intermediates Manufacturing Unit with production capacity of TPM The Location map is shown at Figure and Google earth map showing Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) plant is shown at Figure The site central GPS - coordinates are Latitude: North Longitude: East. The project site does not offer any negative impact on the local area, but rather it has a positive impact on socio economic conditions of the habitants around it because of employment to locals. The Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) is 26 kms away from National Highway NH 16 and 22 kms from Kovvuru Railway station. Page 5

9 FIGURE 1.1: LOCATION MAP Project Site Page 6

10 FIGURE 1.2: GOOGLE EARTH MAP SHOWING TAGOOR LABORATORIES PRIVATE LIMITED Page 7

11 3.1 Proposed Products and Existing Products and their Production Capacities Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) is proposing to Expansion of existing Bulk Drug and Intermediates Manufacturing Unit Capacity of TPM and the list of proposed products and Existing Products are shown in Table 3.1 & 3.2. S. No. Product Name Table 3.1: Proposed Products and Quantities Production Capacity Kg/ Month CAS No. Therapeutic category 1 Abacavir sulfate Anti HIV 2 Amitriptyline Antidepressant 3 Atrovastatin Calcium Hypercholesterolemia 4 Bupropion Anti depressant 5 carisoprodol Muscle Relaxant 6 Clopidogrelbisulfate Antithrombotic 7 Cyclobenzaprine HCl Muscle relaxant 8 Cyproheptadine HCl Anti allergic 9 Desloratadine Antihistamine 10 Domperidone Anti emetic 11 Domperidone maleate Anti emetic 12 Donepezil HCl Alzheimer s disease 13 Ebastine Anti allergic 14 Esomeprazole Sodium Anti ulcerative Esomeprazole Anti ulcerative 15 Magnesium trihydrate Fexofenadine Anti histamine Hydrochloride 17 Haloperidol Antipsychotic 18 Itopride Hydrochloride Antispasmodics 19 Itraconazole Antifungal 20 Ketrolac Tromethane Anti Inflammatory 21 Lansoprazole Ant ulcerative Loperamide Anti diarrhea agent 22 Hydrochloride Losartan Potassium Anti Hypertensive 24 Nebivolol HCl Anti Hypertensive 25 Nortriptyline HCl Anti depressant 26 Omeprazole Anti ulcerative 27 Omeprazole Sodium Ant ulcerative Omeprazole Magnesium Ant ulcerative Dihydrate Page 8

12 S. No. Product Name Production Capacity Kg/ Month CAS No. Therapeutic category 29 Oxatomide Antihistamine Pantoprazole Sodium Ant ulcerative 30 Sesqui Hydrate Pimozide Antipsychotic 32 Pregabalin Epileptic Quetiapine Antipsychotic Hemifumarate 34 Rabeprazole Sodium Ant ulcerative 35 Rupatadine fumarate Antihistamine 36 Telmisartan Anti Hypertensive 47 Terbinafine Anti fungal 37 hydrochloride Valsartan Anti Hypertensive 39 1-Benzy-4-piperidone Drug Intermediate 1-Benzyl Drug Intermediate chloropiperidine 41 1-Benzylpiperidin-4-ol Drug Intermediate 1-Methylpiperidin Drug Intermediate amine 43 4-Aminopiperidine Drug Intermediate 44 4-Hydroxy piperidine Drug Intermediate 45 4-Phenylpiperidine Drug Intermediate 46 4-piperidinopiperidine Drug Intermediate N-tert-Butoxycarbonyl hydroxy piperidine Total ( Worst Combination of any 12 Products at any given point of time) Drug Intermediate Note: The above Listed Products, we will manufacture either Finished Product or any Intermediate stage of finished Product as per given quantity by not increasing the production capacity of 140 MT/Month. Page 9

13 S. No Product Name 1 5-(Difluromethoxy )-2- mercapto -1Hbenzimidazole(BZL) Existing Products - CAS Number Therapeutic category / Application Drug Intermediate Quantity In Kgs/Month Niacin Anti hyper lipidimic N-Methyl-4- Drug piperldone(nmp) Intermediate Paracetamol-API Sodium methoxide (SMO) Antineoplastic Total (Worst combination of any two products on campaign basis only) S. No. Name of Product Table 3.2. List of By-Products Name of the By- Product Quantity in Kg/Day Clopidogrel Bisulphate 1 Omeprazole Magnesium Dihydrate Ammonium Sulphate Cyclobenzaprine HCl Itrazconazole Sodium Bromide Cyclobenzaprine HCl 3 Cyproheptadine HCl Desloratadine Pantoprazole Sodium Sesquihydrate Magnesium Chloride Desloratadine 4 Ebastine Terbinafine HCl Potassium Chloride Desloratadine Aluminum Chloride Domperidone Maleate 6 Pantoprazole Sodium Sesquihydrate Rabeprazole Sodium Sodium acetate Itopride HCl Itraconazole TEA HCl Telmisartan 8 Valsartan Potassium Bromide Itraconazole Page 10

14 S. No. Name of Product Name of the By- Product Quantity in Kg/Day 9 Itraconazole Sodium Benzoate Losartan Potassium Trityl alcohol Pregabalin Potassium acetate Ebastine Hydrogen Chloride Note: The By-Products will be produced according to the combination of required products manufacturing. 3.2 Raw materials required and Quantities All the raw materials required for manufacturing of above products will be sourced from local market. 3.3 Manufacturing Process The manufacturing process of bulk drugs and Intermediates consists of chemical synthesis extending to stages of processing involving different type of chemical reactions. The generalized Flow chart for bulk drug manufacturing is shown in Flow chart 3.1. Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing Page 11

15 3.4 Resource Utilize & Recycling Water Water requirement of the project for domestic and industrial activity during operation phase will be KLD. The water requirement will be met through ground water sources. The detailed water requirement shown in below Table 3.3 Table 3.3: WATER CONSUMPTION DETAILS S.No Purpose Water consumption In KLD 1 Process Washings Boiler make up Cooling towers make up Scrubbing system Domestic Gardening 5.00 Total Power Requirement Power requirement of proposed project will be made available through Andhra Pradesh Southern Power Distribution Company Limited (APSPDCL). The total power requirement for the unit is 800 KVA respectively D.G. sets of Existing 250 KVA (Continued) and 500 KVA is proposed to install to meet the emergency power requirement of the plant Fuel Requirement The existing 6.0 TPH Coal fired/ Agro waste fired Boiler, 2,00,000 kcal/hr. Thermo pack Boiler (Continued) proposed to install 4.0 TPH Coal fired/ Agro waste fired Boiler and total fuel requirement of coal will be around MT /Day and it will be procured from local sources. 3.5 Quantity of wastes to be generated Waste Water Generation and utilization Total effluent will generate in the project is KLD. The treated water will be reused for plant operations. Page 12

16 The HTDS waste water from Process after neutralization taken for treatment in stripper followed by MEE and ATFD, vapor condensate collected and transferred to Biological Treatment. LTDS waste water including domestic sewage, floor Washes, Utilities waste water taken along with Vapour Condensate from MEE & ATFD for Biological Treatment. Treated effluent from BTP sent to RO, RO permeate collected and RO rejects are sent to MEE followed by ATFD for evaporation and separation of salts. Evaporation salts collected and sent to TSDF. MEE & ATFD vapour condensates collected & reused along with RO permeate in plant operations. Table 3.4: Waste water generation and Treatment Method Unit HTDS KLD LTDS KLD Effluent Generation in KLD Treatment Method Process Washings HTDS effluent sent to ETP with MEE System Boiler Blow down Cooling towers Blow down Scrubbing system Domestic Total LTDS effluents treated in ETP RO Plant / RO Rejects to MEE System and RO permeate to reuse, Condensate from MEE to reuse and MEE residue to ATFD. Septic tank followed by soak pit Proposed Solid and Hazardous waste generation and Disposal The types of Solid and Hazardous wastes generated from the project, method of disposal is shown in below table 3.5. Table 3.5: Proposed Solid / Hazardous waste generation and Disposal S. No Name of the Quantity Hazardous Waste Disposal Method 1 Organic waste (Process 1743 Residue) Kg/Day Sent to Cement Industries 2 Spent Carbon 167 Kg/Day Sent to Cement Industries 3 Solvent Distillation Residue 1123 Kg/Day Sent to Cement Industries 4 Inorganic Waste 1216 Sent to TSDF Page 13

17 S. No Name of the Hazardous Waste 5 Spent Mixed Solvents 6 ETP Sludge 7 MEE Salts 8 Organic Evaporative Liquid ( from MEE Stripper) Quantity Kg/Day 2465 Kg/Day Kg/Day 4387 Kg/Day 0.82KLD 9 Used Oils 500L/Annum Disposal Method Sent to authorized recyclers/cement Industries Sent to TSDF Sent to TSDF Sent to Cement Industry SPCB Authorized Agencies for Reprocessing/Recycling After Detoxification sent to 600 No s / Detoxified Containers 10 Month outside agencies. 4 No s/ 11 Used Lead Acid Batteries Annum Solid waste generation and Disposal Ash from boilers (Existing: 6.0 TPH Coal fired/ Agro waste fired Boiler, Thermo pack Boiler Sent to Brick 12 2,00,000 kcal / hr. and Kg/Day Manufacturers Proposed: 4.0 TPH Coal fired/ Agro waste fired Boiler) Send back to suppliers for buyback of New Batteries 3.6 Schematic representations of the feasibility drawing which give information of EIA purpose. The applicability of the S.O.1533 for the proposed project was explored by considering different possibilities & provision made in the said notification. Considering the products & project location of the proposed project it is noticed that the proposed project falls under Category 5 (f) A of the Schedule-I of EIA Notification S.O As per the provision of the SO 1533, it is necessary to get Environmental Clearance by applying to MoEF&CC along with the Environmental Impacts Assessment Study Report for the proposed project prior to commissioning of the project activities. Therefore the EIA is required to conduct to comply with provisions of SO 1533 made for Category 5 (f) A of schedule I of the notification. Page 14

18 4.0. Site Analysis 4.1 Connectivity Tagoor Laboratories Private Limited (Formerly known as Vensub Laboratories Pvt Ltd) located at Survey No: 29, Tupakulagudem (V) Tallapudi (M), West Godavari (Dist.), Andhra Pradesh. Gopavaram village is at a distance of 1.43 KMs in N Direction from the site. Kovvur is a Town; it is at a distance of 20 KMs in SE side from the project site. Site is at a distance of 24 KMs from Rajahmundry in SE direction. Nearest State Highway from the site is SH-42 (Koyyalagudem- Nallajerla) at a distance of 17 KMs in W side from the project site. Nearest National Highway from the site is NH-5 (Rajahmundry - Anakapalle) at a distance of 26 KMs in SE side from the project site. 4.2 Land Form, Land use and Land ownership. The land use of the Area of 11.8 Acres ( Sq.m) will be permanently changed to industrial purpose. 4.3 Existing Infrastructure. The Proposed project proposed to Expansion of existing Bulk Drug and Intermediates Manufacturing Unit which is 26 kms away from NH-17 and Mandal head quarter Tallapudi is 8.50 kms (ESE) from the project site. 4.4 Soil classification The predominant soils in the district are Sandy loams, black cotton soils and coastal sands. 4.5 Climatic data from secondary sources. Annual Max Temp is C Annual Min Temp is C Normal Annual Rainfall is 1078 mm Page 15

19 4.6 Social Infrastructure available. Well developed social infrastructure facilities are available at nearby Habitations. 5.0 Planning Brief Proposed plant activities will be started after getting statutory clearance form related authorities. The project will be completed within two years. Further project management will take care of all the rules and regulation of statutory authority and provide all necessary control measures 6.0 Proposed Infrastructure 6.1 Industrial Area The infrastructure and other facilities are already well developed in Tallapudi, which is a Mandal head quarter. 6.2 Residential Area The employees who will work in the industry are from nearby villages and hence no proposal for residential area for employees. 6.3 Green Belt: SQM (34.50 %) of Green Belt will be developed and maintained. 6.4 Social Infrastructure: Facilities like roads, communication, Banks, ATM's and medical facilities are available. Amenities: Education Schools including middle, secondary and higher secondary schools, social welfare hostels Medical and Health Community Health Centre & Primary Health center are available in Tallapudi which is 8.50 kms ESE of proposed project site. Power and water- All the villages are electrified and drinking water facilities are extended to all villages. Rail and Road- The project site is very well connected by road through National Page 16

20 Highway No. 16 and nearest railway station is Kovvur. 6.5 Water management Water requirement will be met through ground water. 6.6 Sewerage System: There will be no discharge of industrial effluent as company proposing Zero Liquid Discharge (ZLD) system. The treated effluent will be reused. 6.7 Industrial Waste Management: Due to proposed project, the effluent from cooling and Plant/Equipment washing will be generated and treated in the well designed Effluent Treatment Plant. The treated effluent will be reused. 7.0 Rehabilitation and Resettlement (R & R) Plan Rehabilitation & Resettlement (R & R) plan is not applicable to this proposed project. 8.0 Project Schedule & Cost Estimates Proposed project activities will be started after getting statutory clearance form related authorities. The project will be completed within two years. The project cost for proposed Project is 4200 Lakhs (42 Crores) will be used for constructing additional building, Equipments & misc. 9.0 Analysis of Benefits to proposal Local people will get direct financial benefit by way of employment. Local people will get some contracts of supply and services to get indirect income. Company will contribute in improving education and health facilities in nearby area. Page 17