Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 1. Introduction M/s. Sreepathi Pharmaceuticals Ltd. is located at Plot No. 163, Phase - V, IDA Jeedimetla, RangaReddy District in Andhra Pradesh. Sreepathi Pharmaceuticals Ltd. was established in 1986 and obtained Environmental Clearance from MOEF vide Order Post Ex facto No J-11011/145/2005-IA II (I), Dated August 11, 2005 to produce bulk drugs with a capacity of 13.5 TPM. The unit obtained change of product mix from state Pollution Control Board in the year December 2010 with a vide letter No: APPCB/HYD/JDM/289/CFE/HO-2010-2244. In order to meet the market demand it is proposed to expand its capacity from the current 13.5 TPM to 150 TPM using existing infrastructure. A copy of the environmental clearance obtained from MOEF, Government of India in 2005 and certified copy of compliance report obtained MOEF, Government of India, Bangalore Regional office is enclosed at AnnexureI 1 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 2. Introduction of the Project The salient features of the project are described in table below TABLE 1 Salient Features of the Project Location Longitude and latitude Year of establishment Product category Project category as per EIA notification Proposed Activity Total investment on the plant Total Investment on Environmental Infrastructure Total area of the plant Total area of green belt Water requirement Source of water Nearest habitation and distance from the site Nearest surface water bodies Nearest reserve forest Environmentally sensitive areas within 10 km radius Any national parks, wild life sanctuaries within 10 km radius Nearest air port and distance Nearest railway station and distance Industrial Estates/Clusters in 10 KM radius Nearest National Highway Plot No. 163, Phase - V, IDA Jeedimetla, RangaReddy District Andhra Pradesh. 17031’25.0” N Latitude and 78027’03.1” E Longitude 1986 and taken over the unit in 2006 5(F) Bulk Drugs & Intermediates Category A (As the unit is located in 10Km radius of Bollaram and Patancheru clusted which is notified under CEPI) Capacity expansion from 13.5 TPM to 150TPM Current - Rs. 36.5 Crores & Proposed – Rs.10.0 Crores Current - Rs.1.5 crores Proposed - Rs. 2.15 Crores 10668.06 Sq.mts 3520.46 Sq. Mts Total water requirement after expansion 190.79 KLD Fresh water Requirement- 145.79 KLD Recycled water- 45.0 KLD Purchased from outside source through tankers Shapurnagar(V) at a distance of 1.0 Km (SW) Fox sagar – 1.27(E), Hussain sagar – 9.35 Kms(S) Dulapalli reserve forest at a distance of 1.0Kms in North direction None None Rajiv Gandhi International Airport,Shamshabad is nearly 40 Kms from the plant Bharatnagar at a distance of 7.0Kms from the plant Chintal,Jeedimetla,Kajipalli NH-7 3.11 Kms(E) NH- 9 6.04 Kms(S) 2 Pre-Feasibility Report i) Sreepathi Pharmaceuticals Limited Introduction of the company and proponent Sreepathi Pharmaceuticals Ltd. was established in 1986 engaged in manufacturing, developing and marketing of Bulk API'S (Bulk Active Pharma Ingredients), Intermediates, The management at Sreepathi Pharmaceuticals Ltd consists of highly qualified and experienced personnel who have given the company the edge in terms of quality, consistency, timely delivery and with cost effective consciousness. The company is headed by Mr. Srinivas Isola Managing Director, who has taken over the company in the year of 2006. He is a Commerce graduate and he is associated with his Father who is having enormous experience in Chemical and process Industry more than 35 years. Under his able management the company has seen enormous growth and development and has continued to strive to enhance the Productivity. The day-to-day operations at Sreepathi Pharmaceuticals are managed by highly Qualified and Experienced Professionals with perfect blend for zeal and commitment. The Technical Team including Research and Development activities are looked by technically experts with rich experience in R&D and related activities 3 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited About the unit M/s Sreepathi Pharmaceuticals Ltd. had taken over the existing unit in 2006 and obtained Environmental clearance from Ministry of Environment to manufacture Bulk Drugs with a capacity of 13.5 TPM in the year 2005. Quality Management: Strict Manufacturing Practices’ manufacturing process to (GMP) ensure Quality are strict control integrated adherence measures, Good throughout to the the Quality parameters for both in-process and finished products. Manufacturing Facilities inspected and approved by Local Drug authorities. COS has been approved by EDQM. WHO – GMP certification for Active Pharmaceutical Ingredients. 4 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 3. Project Description 3.1 Production Capacity Currently the unit is permitted to manufacture 7 drugs in two groups with a total capacity of 13.5 TPM any one group at a given point of time as detailed below TABLE 2 LIST OF EXISTING PRODUCTS S.No Name of the Product Quantities in TPM 1. Group- A Ciprofloxacin HCL 11.75 2. Quinapyramine Sulphate 0.125 3. Quinapyramine Chloride 0.125 4. Enrofloxacin TOTAL Group- A 1.5 13.5 Group - B 1. Ciprofloxacin HCL 4.5 2. Quinapyramine Sulphate 0.25 3. Quinapyramine Chloride 0.25 4. Enrofloxacin 1.5 5. Norflaxacin 2.0 6. Ofloxacin 3.0 7. Sparfloxacin 2.0 TOTAL Group- B 13.5 Worst case scenario 13.5 5 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 3.1.1 Proposed expansion: It is now proposed to expand the production capacity of the existing 7 products. Below Table provides list of products and proposed capacities. TABLE 3 PROPOSED PRODUCTS & CAPACITY Product Name Production Capacity TPM Product Description Drug/Intermediate /Multipurpose chemicals 1 Ciprofloxacin HCl 110.0 Bulk Drug 2 Enrofloxacin 25.0 Bulk Drug 3 Ofloxacin 3.0 Bulk Drug 4 Norfloxacin 5.0 5 Sparfloxacin 5.0 Bulk Drug 6 Quinapyramine Sulphate 1.0 Bulk Drug 7 Quinapyramine Chloride 1.0 Bulk Drug S.No Total Bulk Drug 150.0 3.2 Manufacturing Process Brief process description and process flow charts are given at Annexure III 3.3 Raw Materials List of raw material product wise is given at Annexure II 6 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 3.4 Water Requirement The water requirement will be met from private suppliers through tankers. The requirement for water in this unit is for process and domestic purposes. The water balance for daily consumption is presented below. TABLE 4.0 Water Balance– Current & Proposed S. No Stream 1. Process 2 Washings Water requirement in KLD Waste Water discharge in KLD Current After Expansi on 5.879 55.79 Current After Expans ion 5.696 45.95 1.5 17.0 1.5 17.0 3 Boiler 4.0 65.0 1.15 6.5 4 Cooling tower 4.0 25.0 1.0 0.5 5 DM Softener -- 2.0 -- 2.0 6 RO Back washes - 14.0 - 14.0 7 Domestic 2.0 5.0 1.5 4.0 8 Gardening 7.0 7.0 -- -- 24.379 190.79 10.846 89.95 Total Proposed Method of Treatment and Disposal MEE followed by ATFD. (Condensate to ETP & RO) ETP and RO and re-use. RO rejects to MEE ETP and RO 7 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 3.5 Wastes generation and control systems 3.5.1 Liquid Effluents As detailed in table 4.0 waste water generation after expansion would be 89.95 KLD. It is proposed to segregate effluents into high COD and High TDS stream and Low COD and Low TDS streams High TDS and High COD stream would be treated in stripper followed by MEE and ATFD. The resultant sludge would be disposed to TSDF, Hyderabad. The Low TDS stream would be treated along with MEE/ATFD condensates in biological ETP followed by RO. The RO rejects would be fed back to MEE. The Permeate from RO would be used for cooling tower make up. Thus the treatment system proposed is based on “Zero Liquid Discharge” (ZLD) Concept The schematic diagrams of ETP proposed are given in Figure 1.1 and Figure 1.2 below 8 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Fig 1.1 Schematic treatment scheme of high TDS effluents Effluent from Process and Equalization Tank washings , Scrubber R&D Neutralization Tank Setting Tank Stripper Aq. Distillate to plants/TSDF Recovery Cement RO Reject To TSDF MEE ATFD Condensate to Biological Treatment Condensate to Biological Treatment SludgeTo TSDF 9 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Fig 1.2 Low TDS Effluent Treatment System Domestic effluent Screen Chamber Effluents from utilities & MEE condensate Screen Chamber Equalization Tank Neutralization Tank Clarifier 1 Aeration Tank1 Aeration Tank2 Clarifier 2 Holding Tank Sludge Holding Tank Sludge to TSDF Sand filter Carbon Filter Filter Press Sludge Cake Permeate for re-use RO Ultra filtration Rejects to MEE 10 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 3.5.2 Solid wastes management Hazardous and non - hazardous wastes generated from the proposed expansion project are detailed below. Mode of disposal are also identified and listed. Adequate storage of hazardous waste is ensured at the site TABLE 5.0 Solid Wastes and Disposal Quantity S.N o Description 1 Spent Carbon 2 Distillation bottom Residue / organic residue 0.188 25.4 3 Inorganic Residue -- 102.4 4 Evaporation salts 2.750 159.0 As per CFO TPM 0.382 After Expansion TPM Remarks 4.23 5 ETP Sludge 0.250 0.350 6 Spent paraffin 0.185 17.06 7 Spent Piperazine ML 373.68 KL/Annum 6181.2 KL/Annum 8 Spent N- Ethyl piperazine ML - 1443.6 KL/Annum 9 Detoxified Container and container 30Nos/ Month 100 Nos/Month Sent to TSDF or Cement Plants for co-processing Sent to TSDF, Dundigal Sent to TSDF, Dundigal Authorized re-cyclers/ re-processors Authorized re-cyclers for recovery Authorized re-cyclers for recovery After Complete detoxification it shall be disposed to the outside 11 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited liners agencies 10 Spent lubricating oil 10 LPM 50LPM 11 Ash from boiler 1.0 TPD 11.4 TPD Authorized re-cyclers/ re-processors Sold to manufactures Brick TSDF facility is about 12.0 KM from the site in Ranga Reddy District which is created for catering the industries in this area. Transport of Hazardous wastes to TSDF is done by the Ramkey. In case other hazardous wastes, authorized recyclers will transport the wastes 4. Site Analysis 4.1 Plant Location M/S Sreepathi Pharmaceuticals Ltd. is located at Plot No. 163, Phase - V, IDA Jeedimetla, Ranga Reddy District in Andhra Pradesh. The site is situated at 17031’25.0” N Latitude and 78027’03.1” E Longitude. The land area of the plant is 1.113 acres. The nearest habitation from the site is Shapurnagar(V) at a distance of 1.0 km. The nearest railway station located at Bharatnagar at a distance of 7.0Kms from the Plant. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site. The site is surrounded by other industries of IDA Jeedimetla. Following are the surroundings of the site North – Natural Health Products South – Road and Vijaya Industries East – Road and Substation West - Naala and Vacant land 12 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Following 8 reserve Forests are there within 10 KM radius of the site Table 6.0 Reserve Forests in the study area S.No Reserve Forest 1 2 3 4 5 6 7 8 Dulapalli GajulaRamaram Suraram Bowrampet Pochampalli Goudavalli Dundigal Kajipalli Direction Distance from the from the site site N 1.0 NW 3.07 NW 4.12 NW 4.9 N 5.2 N 6.7 NW 9.0 NW 12.0 Topo graphic features of the site and 10 KM study area and base map are given at Fig 1.3 & 1.4. Plant Photographs are given at Fig. 1.5 Site lay out map is given at Fig 1.6 13 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Fig 1.3 Topo Sheet of the 10 KM study area 14 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Fig 1.4 Base map of the study area 15 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Fig 1.5 Plant & Green Belt Photographs 16 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Fig 1.6 Site lay out plan 17 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 5.0 Planning in Brief The project is envisaged to be completed by December 2014, and the production shall be initiated thereon. Consultants are identified for preparing the detailed project report. 6. Resource requirements 6.1 Power Requirement and Supply/Source The total power requirement is 1250 KVA. It shall be sourced from APCPDCL and D.G sets as alternative to Power failure. 6.2 Production facilities , Utilities and effluent handling facilities Apart from the existing facilities it is proposed to add additional production facilities, utilities and effluents treatment infrastructure with an additional investment of Rs. 10.0 Cores. The details are outlined in the below table TABLE 7.0 Production facilities/Utilities/ETP – Existing & Proposed S.NO Details Capacity/ No After Current Additions expansion Production facilities 1 2 Production BlocksPharma/ Clean rooms Utilities Nos Nos 3 4 5 6 8 9 10 11 12 Boiler ( coal Fired) TPH 4 DG sets KVA 1 X 320 Cooling tower TR 1700 Softner/DM plant M3/hour 5 Effluent handling & treatment facilities collection tanks KL 35 Effluent storage tanks KL 15 Neutralisation tanks KL 15 Stripper ,MEE,ATFD KLD -Biological treatment KLD -- 13 RO plant KL/ Hr 3 2 -- 1 1 4 3 8 2 X 500 500 5 12 1320 2200 10.0 50 50 50 2 X 60 100 85 65 65 120 100.0 5.0 5.0 18 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 6.3 Land Requirement The unit currently has 2.63 acres of land and out of which 3520.46 Sq. mtrs of green belt is developed. The land requirement for proposed expansion activities will be 1954.94 Square Meters which can be met from existing open area. Below table provides the land statement. Detailed site lay out plan outlining current and proposed expansion activities is given at Figure 1.5 Table 8.0 Land Statement S.NO 1 2 3 4 5 Purpose Built up area Roads area Green belt Open area Total Area required for Proposed expansion Units Sq.M Sq.M Sq.M Sq.M Sq.M Sq M Extent 3054.14 2138.52 3520.46 1954.94 10668.06 1954.94 7.0 Air Pollution The Sources of air emissions from the plant are 4 TPH coal fired boiler & proposed 8TPH coal fired boiler and additional DG sets The process emissions from the second phase contain 2 No’s of scrubbers are scrubbed with caustic lye and HCl separately and scrubbed waste send to MEE. The other gases expected in the process are Carbon dioxide, which are let out into atmosphere. Below Table gives current proposed emission sources from the plant 19 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Table 9.0 Emission Source – Current & Proposed S.No Parameter Capacity Fuel Anticipated emissions 1 Existing Process --- -- 2 Boiler stack 4 TPH Coal 3 DG sets 1x 320 KVA Diesel SPM,SO2 &NOx 1 Proposed (additions) Boiler 8TPH Coal SPM,SO2 &NOx 2 DG set 2x 500 KVA diesel SPM, SO2, NOX 3 Process -- -- HCl, DMA, SO2 HCl, DMA, SO2 SPM,SO2 &NOx Control system Scrubbed with caustic lye/HCl Stack Ht 30 meters, Cyclone separator Stack Ht 3.5 mts, Acoustic enclosures Bag filter &Stack Ht 30 meters Stack height of 4.5 meters & acoustic enclosure Scrubbed with caustic lye/HCl 8.0 Bulk Chemical Storages: Following bulk chemical storage facilities are proposed for expansion activity Table No 10.0 Storage facilities of bulk chemicals (Existing) Sr No 1 2 3 4 5 6 7 8 Capacity (KL) 20 27 35 60 20 20 20 10 Name of the solvent Acetic acid Dil. Acetic acid HCl Methanol DMS Toluene CS lye N- Butanol MOC PP FRP PP FRP PP FRP M.S M.S M.S M.S M.S 20 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited 9.0. Project Financial The estimated cost of the expansion project is approximately 10.0 Crores. Out of this Rs. 2.15 Crores will be for effluents treatment facilities and rest for other process equipment and safety equipment Project cost Rs. In Crore 3.0 cr 2.8 cr Total 5.8 cr Plant& machinery + AHU+ Boiler Civil & structural Pipe lines & insulation Electricals & instrumentation Erection & commissioning & painting Safety & Environment Furniture, fixtures, computers, lighting etc 20% on plant & machinery 10% on plant & machinery 8% on plant & machinery and structures 0.60 cr 0.50 cr 0.40cr 2.15cr Total Contingencies & pre-operative expenses Project cost 0.10 cr 9.55 cr 0.45 cr 10.0 cr 21 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Annexure I Copy of EC & Certified Compliance report from MOEF, Bangalore 22 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Annexure II List of Raw Materials 23 Pre-Feasibility Report Sreepathi Pharmaceuticals Limited Annexure III Typical Process description and flow sheets 24