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PRE - FEASIBILITY REPORT

For

EXPANSION OF

EXISTING MANUFACTURING UNIT

at

Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally, Ibrahimpatnam Mandal, Krishna District, Andhra Pradesh.

by

ORCH LABORATORIES INDIA PVT. LTD

Plot No: 44, Palampally Villas, Opp. Karur Vysya Bank

Nizampet Road, Kukatpally Telangana State.

Contents

S. No. Description Page no.

1.0 Executive Summary 1

2.0 Introduction of The Proposed Project 2

2.1 Project Proponent 2

2.2 Brief description of nature of the project. 2

2.3 Need for the project and its importance to the country and or

region 2 - 3

2.4 Demand-Supply Gap. 3

2.5 Employment Generation(Direct and Indirect) due to the project 3

3.0 Project description 4

3.1 Existing Products, Proposed Products and By- Products and Production Capacity

7-8

3.2 Raw materials required and Quantities 8

3.3 Manufacturing Process 9

3.4 Resource – Utilize and Recycling 9

3.4.1 Water 9

3.4.2 Power Requirement 10

3.4.3 Fuel Requirement 10

3.5 Quantity of wastes to be generated 10

3.5.1 Waste Water Generation and utilization 10

3.5.2 Hazardous Waste, Solid waste generation and Disposal 10

3.6 Schematic representations of the feasibility drawing which give information of EIA purpose.

11

4.0 Site Analysis 12

4.1 Connectivity 12

4.2 Land Form, Land use and Land ownership. 12

4.3 Existing Infrastructure 12

4.4 Soil classification 12

4.5 Climatic data from secondary sources. 12

4.6 Social Infrastructure available. 12

5.0 Planning brief 12

6.0 Proposed infrastructure 12

6.1 Industrial Area 12

6.2 Residential Area 12

6.3 Green Belt: 13

6.4 Social Infrastructure 13

6.5 Water management 13

6.6 Sewerage System 13

6.7 Industrial Waste Management 13

S. No. Description Page no.

7.0 Rehabilitation and Resettlement (R&R) Plan 13

8.0 Project Schedule and Cost estimates 14

9.0 Analysis of project 14

LIST OF TABLES

Table No Description Page no. 2.1 Proposed Employment for expansion 4 3.1 List of Existing Products 7 3.2 Proposed Products and Quantities 7 - 8 3.3 By-Product and Quantities 8 3.4 Water Requirement Details 10 3.5 Wastewater generation and Treatment Method 10 3.6 Hazardous / Solid Waste Details generation and Disposal 10-11

LIST OF FIGURES

Figure No Description Page no.

1.1 Location Map 5 1.2 Google Earth Map Showing Orch Laboratories India Pvt. Ltd 6

LIST OF FLOW CHART

Flow Chart No Description Page no. 3.1 Generalized Flow Chart for Bulk Drug Manufacturing 9

Pre-Feasibility Report Orch Laboratories India Pvt. Ltd

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 1

1.0 EXECUTIVE SUMMARY

Orch Laboratories India Pvt. Ltd was incorporated as Private sector under

companies Act, 1956 (No.1 of 1956) situated at IDA Kondapally, Vijayawada in the

state of Andhra Pradesh, India during the year 2011-2012. The company is engaged

in the manufacturing of intermediates for supply to the domestic as well as overseas

market.

Orch Laboratories India Pvt. Ltd got Environmental Clearance for manufacturing of

Bulk Drug and Drug Intermediates vide EC letter no SEIAA/AP/SKM - /2011 - 1992

dated: 04.03.2015 and obtained certified compliance report on existing EC Vide F.

No. EP/12.1/2014-15/ SEIAA /126/AP/0726 dated: 11.05.2017

S. No Parameter Description

1 Project Location Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally, Ibrahimpatnam Mandal, Krishna District, Andhra Pradesh.

2 Category of Project as per EIA Notification & Amendments

5(f) “B”

3 Project cost 480 lakhs (proposed expansion)

4 Plot area 5226.52 Sqm

5 Proposed Product Proposed Products List is mentioned in section 3.2

6 Resources

(i)Electricity Requirement

Source of electricity APSPDCL

D. G. Sets

Existing : 125 KVA Proposed : 500 KVA

(ii)Water consumption 100.89 KL/day

Source of water IDA

Waste water generation 38.76 KL/ day

Mode of disposal CETP , Kondapalli

(iii)Boiler Coal Fired Boilers Existing : 2.00 TPH Dropped Proposed : 4.0 TPH Proposed

(iv)Fuel Coal Requirement – 10.0 MT /Day for proposed 4.0 TPH Coal fired boiler

7 Solid waste generation Mentioned in Para 3.6 of report

8 Nearest Highway

National Highway No.30 (Vijayawada – Mylavaram Road)- 0.85 KMs (E)

9 Nearest Railway Station Kondapalli Railway Station – 2.85 KMs (SSW)

10 Nearest Air Port Vijayawada Airport- 28.60 KMs (ESE)



2.0 INTRODUCTION OF THE PROJECT

M/s. Orch Laboratories India Pvt. Ltd., has its Bulk drug manufacturing plant at

Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally, Ibrahimpatnam Mandal, Krishna

District , Andhra Pradesh.

2.1 Project Proponent

Mr. P. Butchinayudamma Aged about 49 years, is a Commerce Graduate with over

25 years of experience in Commercial and Financial activities of large industrial

undertakings. Mr. Butchinayudamma is responsible for Commercial and Financial

activities of the company.

Mr. P. Madhusudhan Reddy Aged about 49 years, is a Civil Engineering Graduate,

with over 25 years of experience. He has rich experience in Industrial construction

particular Pharmaceutical industries. He has rich knowledge and expertise in

compliance with schedule M of Drugs and cosmetics Act, which became mandatory

since 2005.

Mrs. K. Usha Rani Aged about 45 years, is a Commerce Graduate with about 15

years of experience in the General Administration and HRD. She is currently on the

Board of M/s. Srimaan Industries Pvt Ltd., a company engaged in construction of

commercial and residential complex.

Mr. Y. Srinivas Rao Aged about 50 years, Mr. Y.Srinivas Rao is a with about

experience in the trading business. He is currently Director in Akhil Drugs Pvt Ltd. &

Eswar Bio Briquette India Pvt Ltd.

2.2 Brief description of nature of the project.

The proposed expansion is to manufacture Bulk Drugs and intermediates, which are

active ingredients with medicinal properties.

2.3 Need for the project and its importance to the country and or region

Active Pharmaceutical Ingredients (API) or bulk drugs are the principal ingredients

for finished pharmaceutical products. Intermediates are the compounds from which

active pharmaceutical ingredients are prepared. APIs cannot be administered

directly to the patient, and other inactive substances called excipients are added to



stabilise the mixture. This end product, which includes the API and the excipient, is

referred to as a formulation. Formulations are the pharmaceutical products

administered to patients and can take the form of tablets, capsules, syrups,

ointments, creams, injectables, etc.

The Indian pharmaceutical industry currently tops the chart amongst India's science-

based 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

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 domestic market accounts for 90% of the company’s total revenue and supplies

its products to Leading Pharma industries of domestic and international clients.

2.4 Demands-Supply Gap

There is a quite considerable gap between supply and demand for 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. 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

The Estimated employment generation for this proposed expansion is about Indirect

- 20 and direct operation after expansion – 30 employees. 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.



Table 2.1: Details of Employment for Proposed expansion

Particulars Employees for

proposed Functional Area

Key managerial staff 4 Finance, Marketing, Production,

Quality control, R&D, Logistics etc.

Administration 3 Office work

Skilled and semi

skilled 23

Production Process, Maintenance,

stores, Safety.& Un skilled workers

Total 30

3.0 Project Description

M/s. Orch Laboratories India Pvt. Ltd proposes for expansion its manufacturing

capacity and products at Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally,

Ibrahimpatnam Mandal, Krishna District, Andhra Pradesh. The Location map is

shown at Figure – 1.

The site coordinates are

Latitude: 16°39'0.53"N

Longitude: 80°33'13.82"E

The site well connected to road and rail way line. No archaeological, historical sites

located nearby. Therefore, the project site does not offer any negative impact on the

local area as because it is an expansion of existing unit in notified industrial area, but

rather has a positive impact on socio economic conditions of the habitants around it.

The plant is well connected both to National Highway No– 30 and Railway line at

Kondapalli Railway Station.



FIGURE 1.1: LOCATION MAP

Plant Site



FIGURE 1.2: GOOGLE EARTH MAP SHOWING ORCH LABORATORIES INDIA PVT LTD



3.1 Existing Products, Proposed Products and By- Products and Production Capacity

Orch Laboratories India Pvt. Ltd proposes for expansion to produce the below

mentioned shown in Table 3.1, Table 3.2. & Table 3.3

Table 3.1 List of Existing Products and Quantities

S. No. Products Name Quantity in

Kg/Day Quantity in Kg/Month

1 Omeprazole 18.33 550.00 2 Atorvastatin Calcium 23.33 700.00 3 Carvedilol 20.00 600.00 4 Ciprofloxacin 32.33 970.00 5 6-chloro-2-hexanone 32.33 970.00 6 Abacavir sulfate 30.00 900.00 7 Celecoxib 33.00 990.00 8 Clopidogrel bi sulphate 31.67 950.00 9 Di potassium hydrogen phosphate 20.00 600.00

10 2-[4-(4-Chloro-Butyryl)-phenyl ] -2-methyl -propionic acid methyl ester 33.67 1010.00

11 Lamivudine 500.00 15000.00 12 Montelukast Sodium 34.33 1030.00

13 (4-hydrazino-phenyl)-N-methyl-methanesulfonamide hydrochloride

33.33 1000.00

14 Tenofovir disoproxil fumarate 16.67 500.00 Total production at worst combination 666.66 20000.00

Note: The industry will manufacture any Six at a given point of time so that the

Maximum production capacity will not exceed 666.66 Kg/Day

Table 3.2: Proposed Products and Quantities

S. No.

Products Name Quantity

in Kg/Month

CAS Number

Therapeutic category

Group-A 1 6-Chloro-2-Hexanone 2500.00 10226-30-9 Drug Intermediate 2 Abacavir Sulphate 2500.00 136470-78-5 Antiretroviral agent

3 Celecoxib 2500.00 169590-42-5 Anti Inflammatory agent

4 Etoricoxib 2500.00 202409-33-4 Antirheumatics

5 CHE-1 (L-Menthyl glyoxilate)

30000.00 - Drug Intermediate

6

CHE-2 (5-Hydroxy-1,3-oxathiolane-2- carboxylicacid(1R,2S,5R) menthyl ester)




S. No.

Products Name Quantity

in Kg/Month

CAS Number

Therapeutic category

7 Cyclo propyl thioacetic acid


8 Ritonavir 2500.00 155213-67-5 Antiretroviral agent

Total 55000.00

Group-B

1

CHE-3 (5-(4-Amino-2-oxo-2H-Pyrimidinyl-[1,3]-oxathiolane -2-carboxylic acid-2-isopropyl-5-methyl cyclo hexyl ester)


2

FCE(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-2H- pyrimidin-1-yl)-[1,3]-oxathiolane-2- carboxylic acid,2S-Isoprpyl-5R-Methyl-1R- Cyclohexyl ester


Total (Worst Combination of either one product or combination of two products with a production capacity of 30MT/Month)

30000.00

Grand Total (Group-A + Group-B)

85000.00

Note: Industry proposes to manufacture either final Drug or Drug intermediates with

above mentioned capacities.

Table 3.3 List of By-Products

S. No

Name of the Product

Name of the By-Product

Quantity

In Kg/Day

1

5-(4-Amino-2-oxo-2H-Pyrimidinyl-[1, 3] Oxathiolane-2-carboxylic acid-2-Isopropyl-5-methyl cyclo hexyl Ester (CHE-3)

TriethylamineHydrochloride 372.02

2 Cyclopropylthioaceticacid TriethylamineHydrochloride 185.83

3

2R, 5S)-5-(4-Amino-5-Fluoro-2-Oxo-2H-Pyrimidin -1-Yl)-[1, 3]-Oxathiolane-2-Carboxylic Acid, 2S-Isopropyl-5R-Methyl-1R-Cyclohexyl Ester. (FCE)

Triethylaminehydrochloride 367.42



3.2 Raw materials required and Quantities

All the raw materials required for manufacturing of above products will be sourced

from local market. The products wise required raw materials and quantities are

enclosed.

3.3 Manufacturing Process

The manufacturing process of bulk drugs 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

3.4 Resource – Utilize & Recycling

3.4.1 Water

Water requirement of the project for domestic and industrial activity during operation

phase will be 100.89 KLD. The water requirement will be met through IDA supply.

The detailed water requirement shown in below Table 3.4



Table 3.4: WATER REQUIREMENT DETAILS

S. No Purpose Water Input in KLD

1 Process 16.87

2 Washings 5.00

3 Boiler make up 23.52

4 Cooling towers make up 45.50

5 Scrubbing system 2.00

6 Domestic 4.00

7 Gardening 4.00

Total 100.89

3.4.2 Power Requirement

Power requirement of proposed expansion project will be made available through

APSPDCL. Total power requirement after expansion will be 800 KVA.

In Addition to existing 125 KVA, 500 KVD DG set is being proposed to meet

emergency power requirement of the plant.

3.4.3 Fuel Requirement

Proposed to install 4.0 TPH coal fired Boiler for expansion by dropping existing

2.00 TPH Capacity coal fired Boiler and Total fuel requirement will be around 10.0

TPD coal after Expansion. The Coal will be procured form local sources.

3.5 Quantity of wastes to be generated

3.5.1 Waste Water Generation and utilization

Total effluent generated in the project is 38.76 KLD which is pre-treated in the plant

and sent to Kondapalli CETP for further treatment of the effluent.

Table 3.5: Wastewater generation and Treatment Method

S. No.

Purpose HTDS in KLD

LTDS in KLD

Effluent in KLD

Disposal Method

1 Process 16.23 3.61 19.85 After preliminary treatment of Effluent (HTDS & LTDS) in the plant, sent to CETP Kondapally IDA.

2 Washings 5.00 0.00 5.00 3 Boiler blow down 0.00 3.36 3.36 4 Cooling towers blow down 0.00 5.05 5.05 5 Scrubbing system 2.00 0.00 2.00 6 Domestic 0.00 3.50 3.50

Total 23.23 15.52 38.76



3.5.2 Hazardous Waste, Solid waste generation and Disposal

The types of Solid and Hazardous wastes generated from the project, method of

disposal is shown in below table 3.6.

Table 3.6: Solid & Hazardous Waste generation and Disposal

S. No. Description Quantity In Kg/Day

Method Of Disposal

1 Organic Solid Waste 312 Sent to Cement Industries 2 Inorganic Solid Waste 1313 Sent to TSDF 3 Spent Carbon 59 Sent to Cement Industries 4 ETP Sludge 50 Sent to TSDF 5 Fly ash from Boiler 3500 Sent to Brick Manufacturers

6 Solvent Distillation Residue

574 Sent to Cement Industries

7 Waste Oils & Grease 300

Ltrs/Annum SPPCB Authorized Agencies for Reprocessing/Recycling

8 Container liners 500

No’s/Month After Detoxification sent to outside agencies.

9 Used Lead Acid Batteries 2 No’s/Annum 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) “B” of the Schedule-I of EIA

Notification SO 1533.

As per the provision of the SO 1533, it is necessary to get Environmental Clearance

by applying to MoEF 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) “B” of schedule –I of the notification.



4.0Site Analysis

4.1 Connectivity

Orch Laboratories India Pvt. Ltd is having well developed road and Rail way line

Connections for transportation of raw materials and finished products.

• The nearest habitation from the site is Kattubadipalem at a distance of 0.85 Km -

NE.

• The nearest railway station is Kondapalli Railway station at a distance of 2.85

KMs – SSW from the site.

• The nearest airport is Vijayawada Airport at a distance of 28.60 KMs - SE at

Gannavaram.

• The Nearest road ways National Highway No.30 (Vijayawada - Mylavaram Road)

– 0.85 KMs - E

4.2 Land Form, Land use and Land ownership

The proposed expansion is in existing area only and located in Notified Industrial

Area. There would be no any change in Land Use, Land Cover or Topography of

plot.

4.3 Existing Infrastructure

Proposed project is an expansion within existing facility and the basic infrastructure

is already there.

4.4 Soil classification

The district is mainly covered by three types of Red loamy soils, Sandy soils, Black

soils.

4.5 Climatic data from secondary sources

Annual Temperature Maximum : 38o C

Minimum : 20o C

Normal annual rainfall 1011 mm

4.6 Social Infrastructure available

Well developed social infrastructure facilities are available at nearby Habitations.

5.0 Planning Brief

Proposed plant expansion activities will be started after getting statutory clearance

form related authorities. The project will be completed within two years.



Further proposed project activities will take care of all the rules and regulation of

statutory authority and provide the control measure and devices to achieve the

standard norms.

6.0 Proposed Infrastructure

6.1 Industrial Area

Basic infrastructure developed already and the required plant and machineries will

be installed after getting statutory clearance.

6.2 Residential Area

No residential area is involved in the proposed project. The employs are

accommodated in nearby Residential areas

6.3 Green Belt:

Area of 313.59 SQM (6 %) green area developed within the plant site, In addition to

the above Orch Laboratories Pvt Ltd got permission from Kondapalli Notified Gram

Panchayath Industrial Area Service Society to develop Green belt in an area of 4487

Sq.mts in the industrial Development Park.

6.4 Social Infrastructure:

Facilities like road and communication are good. Banks; ATM's and medical facilities

are also adequate.

Amenities:

Education- schools including middle, secondary and higher secondary schools,

social welfare hostels.

Medical and Health- Community Health Centre, & Primary Health center Are

available near villages

Power and water- All the villages are electrified and drinking water facilities are

extended to all villages.

Rail and Road- The plant site is very well connected by road through National

Highway No. 30, Kondapalli railway station.

6.5 Water management

Water requirement will be fulfilled through Industrial Development Authority.



6.6 Effluent Treatment System

An industrial effluent of 38.76 KL/ day is generated and will be sent to Kondapalli

CETP. Domestic waste water will be sent to septic tank followed by soak pit .

6.7 Industrial Waste Management:

Due to proposed expansion, the effluent from cooling and Plant/Equipment washing

will be sent to CETP Kondapalli.

7.0 Rehabilitation and Resettlement (R & R) Plan

Rehabilitation & Resettlement (R&R) plan is not applicable to proposed project.

8.0 Project Schedule & Cost Estimates

Proposed Expansion activities will be started after getting statutory clearance form

related authorities. The cost of the proposed expansion will be approximately 4.80

Crores the project will be completed within two years.

9.0 Analysis of proposal (Final Recommendations)

Proposed expansion activity will provide benefits to the local people in terms of

financial and social welfare.

� 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.

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