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PRE FEASIBILITY REPORT

FOR

EXPANSION OF EXISTING BULK DRUG INTERMEDIATE MANUFACTURING UNIT

M/S. ORTIN LABORATORIES LTD., UNIT-II

At

Sy No: Parts of 300 & 301, Malkapur (V), Choutuppal (M), Nalgonda (Dt), Telangana State

Contents

S. No. Description Page no. 1.0 Executive Summary 1 2.0 Introduction of The 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

2.4 Demand-Supply Gap 3

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

3.0 Project description 4 -6 3.1 Product and Production Capacity 7 3.2 Raw materials required and Quantities 7 3.3 Manufacturing Process 7 3.4 Resource – Utilize and Recycling 8

3.4.1 Water 8

3.4.2 Power Requirement 9 3.4.3 Fuel Requirement 9 3.5 Quantity of wastes to be generated 9

3.5.1 Waste Water Generation and utilization 9 3.5.2 Solid waste generation and Disposal 10

3.6 Schematic representations of the feasibility drawing which give information of EIA purpose. 10

4.0 Site Analysis 11 4.1 Connectivity 11 4.2 Land Form, Land use and Land ownership. 11 4.3 Existing Infrastructure 11 4.4 Soil classification 11 4.5 Climatic data from secondary sources. 11 4.6 Social Infrastructure available. 11 5.0 Planning brief 12 6.0 Proposed infrastructure 12 6.1 Industrial Area 12 6.2 Residential Area 12 6.3 Green Belt: 12 6.4 Social Infrastructure 12 6.5 Water management 13

6.6 Sewerage System 13 6.7 Industrial Waste Management 13 7.0 Rehabilitation and Resettlement (R&R) Plan 13 8.0 Project Schedule and Cost estimates 13 9.0 Analysis of project 13

LIST OF TABLES

Table No Description Page no. 2.1 Total Employment 3 3.1 Proposed Products and Quantities 7 3.2 Water Requirement Details 9 3.3 Wastewater generation and Treatment Method 9 3.4 Solid and hazardous waste generation and Disposal 10 8.1 Project Cost 13

LIST OF FIGURES

Figure No Description Page no. 1.1 Location Map 5 1.2 Google Earth Map Showing Ortin Laboratories Ltd 6

LIST OF FLOW CHART

Flow Chart No Description Page no.

3.1 Generalized Flow Chart for Synthetic organic chemicals Manufacturing

8


M/s. Ortin Laboratories Ltd., Unit-II Page 1

1.0 EXECUTIVE SUMMARY

M/s. Ortin Laboratories Ltd is a limited company established in the year 1986 to

offer quality Drugs and Medicines to the suffering mankind. Vineet Laboratories is an

established Drug Intermediates manufacturing unit, majorly involved in the

preparations of intermediates for Anti-Retro Virals and Lipid Lowering Agents having

manufacturing unit at Choutuppal, Nalgonda District.

In the year 2011, M/s Vineet Laboratories Pvt Ltd has been merged with Ortin Laboratories Ltd.

S. No Parameter Description

1 Project Location Sy No: Parts of 300 & 301, Malkapur (V), Choutuppal (M), Nalgonda (Dt), Telangana State

2 Category of Project as per EIA Notification & Amendments

5 F(A)

3 Project cost 20.0 Crores

4 Plot area 6.725 Acres

5 Proposed Products List of proposed products are Enclosed

6 Resources

(I)Electricity Requirement 750 HP

Source of electricity TSSPDCL

D. G. Sets Existing : 380 KVA & 500 KVA Continued Proposed : 500 KVA

(II)Water consumption 130.22 KLD

Source of water Ground Water

Waste water generation 59.60 KLD

7 Solid waste generation

Organic Residue – 748 Kg/Day Inorganic waste – 405 Kg/Day MEE salts – 1805.00 Kg/Day Spent carbon – 103 Kg/Day Coal ash from Boiler – 7050 Kg/Day ETP Sludge – 30 Kg/Day Solvent Distillation Residue – 117 Kg/Day

8 Nearest Highway NH 9 – 1.9 KMs SSW 9 Nearest Railway Station Bibinagar Railway Station - 19.8 Km

10 Nearest Air Port Rajiv Gandhi International Airport - 41.0 KM



2.0 INTRODUCTION OF THE PROJECT

The objective of this pre- feasibility study is to provide information for the expansion

of unit of M/s. Ortin Laboratories Ltd., Unit-II Sy No: Parts of 300 & 301, Malkapur

(V), Choutuppal (M), Nalgonda (Dt), Telangana State

2.1 Project Proponent Mr. G. Venkata Ramana is Director of the Company. He has been in the bulk drug

manufacturing industry more than two decades and gained experience in API’s

process developments and commercialization.

Mr. K. Murali Mohan is Director of the Company. He has been in the bulk drug

industry more than 20 years.

2.2 Brief description of nature of the project. M/s. Ortin Laboratories Ltd., Unit- II is an established Drug Intermediates

manufacturing unit, majorly involved in the preparations of intermediates for Anti-

Retro Virals and Lipid Lowering Agents, at Malkapur (V), Choutuppal (M),

Nalgonda (Dt), Telangana State

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

We have collaborations with exporters who want high quality formulations for export

to other countries. We are interested in having our Products registered in various

countries. We require agency representations from different countries in the world.

We are also interested in manufacturing and exporting the Drug API Intermediates

as per the customer’s requirements in addition to our existing ranger products of

Retro-virals, Lipid lowering agents etc.



Promoters of Ortin bring many years of technical experience to the business with a

commitment to marketing and growth. The company believes that it is well positioned

to capitalize on a very large, rapidly growing and lucrative market.

2.4 Demand-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 unit has 40 permanent and 20 contractual employees. Apart from this there will

be significant indirect 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. The details of total

employment in this unit shown in below Table 2.1.

TABLE 2.1: TOTAL EMPLOYMENT AFTER EXPANSION

Particulars No. of employees

Functional Area

Key managerial staff 15 Finance, Marketing, Production,

Quality control, R&D, Logistics etc.

Administration 8 Office work

Skilled and semi

skilled 47

Manufacturing, Maintenance, Stores

& Un skilled workers and contractors

Total 70



3.0 Project Description

M/s. Ortin Laboratories Ltd., Unit - II is an established Drug Intermediates

manufacturing unit, majorly involved in the preparations of intermediates for Anti-

Retro Virals and Lipid Lowering Agents, at Malkapur (V), Choutuppal (M),

Nalgonda (Dt), Telangana State.

The Location map is shown at Figure -3.1 and Google earth map showing Ortin

Laboratories Ltd. plant is shown at Figure -3.2 .

The site central coordinates are Latitude : 17°17'32.41"N Longitude : 78°49'8.92"E

There are no archaeological, historical sites located nearby. Therefore, the project

site does not offer any negative impact on the local area, but rather has a positive

impact on socio economic conditions of the habitants around it.

The Ortin Laboratories Ltd., Unit - II is 1.9 Km away from NH 9 and 19.8 Kms. from

Bibinagar Railway Station.



FIGURE 3.1: LOCATION MAP

Ortin Laboratories Ltd., Unit -II Sy No: Parts of 300 & 301, Malkapur (V), Choutuppal (M), Nalgonda (Dt), Telangana State



FIGURE 3.2: GOOGLE EARTH MAP SHOWING ORTIN LABORATORIES LTD., UNIT-II



3.1 Product and Production Capacity

M/s. Ortin Laboratories Ltd., Unit - II is proposes to produce below mentioned

products with Manufacturing Capacity 660.02 MT/Month and the list of product is

shown in Table3.1.

Table3.1: Proposed Products and Quantity

S. No Name of the Product CAS

Number Therapeutic

Category Quantity

In MT/Month

1 Amitriptyline hydrochloride 549-18-8 Antidepressant. 1.62

2 Ciprofloxacin Hydrochloride 86483-48-9 Anti-infective 3.00

3 Cisapride mono hydrate 260779-88-2 Gastroprokinetic agent 1.40

4 Domperidone 57808-66-9 Antiemetic 2.00 5 Fexofenadine Hydrochloride 153439-40-8 Antihistamine 3.00 6 Fluconazole 86386-73-4 Antifungal 3.00

7 Lopinavir 19275-17-0 Antiretroviral Agent. 2.00

8 Nadolol 42200-33-9 Cardiovascular Agent. 1.00

9 n-Butyl Lithium 109-72-8 Organolithium Reagent 35.00

10 Pantoprazole sodium 138786-67-1 Proton pump inhibitor 2.00

11 Pregabalin 148553-50-8 Neuropathic Pain Agent 2.00

12 Ritonavir 155213-67-5 Antiretroviral Agent 2.00

13 Sildenafil Citrate 171599-83-0 Anti-erectile dysfunction agent. 2.00

Total 660.02

3.2 Raw materials required and Quantities All the raw materials required for manufacturing of above products will be sourced

from local/Non local market. The required raw materials and quantities are enclosed

as Annexure.

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 synthetic organic chemicals manufacturing is shown in

Flow chart 3.1.



FLOW CHART 3.1: GENERALIZED FLOW CHART FOR SYNTHETIC ORGANIC CHEMICALS 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 130.22 KLD. The water requirement will be met through ground water.

The detailed water requirement shown in below Table 3.2.

Table 3.2: WATER REQUIREMENT DETAILS

S. No Purpose Water Requirement In KLD

1 Process 31.22 2 Washings 2.00 3 Boiler Daily Make up 35.00 4 Cooling Towers Daily Make up 51.00 5 DM Plant 2.00 6 Scrubbing system 2.00 7 Domestic Usage 2.00 8 Gardening 5.00 Total 130.22



3.4.2 Power Requirement Power requirement of proposed project will be made available through TSPCPDCL.

The total power requirement for the unit after expansion is 750 Hp respectively.

Proposing to Install 500 KVA DG set In addition to existing 380 KVA & 500 KVA DG

Sets to meet the emergency power requirement of the plant for the proposed

Expansion.

3.5 Quantity of wastes to be generated

3.5.1 Waste Water Generation and utilization

Total effluent generated in the project is 59.57 KLD. The process waste water from

Process, floor Washes, scrubbers, DM Plant, boilers and Cooling towers are

evaporated in MEE with stripper and ATFD after neutralization. The condensate from

MEE and ATFD will be collected and treated in effluents treatment plant along with

effluents from utilities followed by RO. RO rejects will be send back to MEE and RO

Permeate will be re-used back.

To treat the sewage generated due to domestic activities will be disposed through

septic tank following by soak pit.

Table3.3: WASTEWATER GENERATION

S. No Unit HTDS

KLD LTDS KLD

Effluent Generation in KLD

Treatment Method

1 Process 31.67 1.90 33.57 HTDS Effluent after neutralization, filtration sent to MEE. LTDS effluents along with MEE condensate will be sent to Biological treatment and finally to RO system RO Rejects to MEE system and RO permeate to reuse; MEE residue to ATFD for drying.

2 Washings 0.00 2.00 2.00 3 Boiler Blow down 5.00 0.00 5.00 4 Cooling towers Blow down 0.00 13.00 13.00 5 DM Plant Regeneration 2.00 0.00 2.00

6 Scrubbing system 2.00 0.00 2.00

7 Domestic 0.00 2.00 2.00 Septic tank followed by soak pit

Total 40.67 18.90 59.57

3.5.2 Solid waste generation and Disposal

The types of Hazardous and non Hazardous wastes generated from the project,

method of disposal is shown in below table -3.4.



Table 3.4: Solid & Hazardous waste generation and Disposal S. No

Name of the Hazardous Waste

Quantity Kg/Day Disposal Method

1 Organic waste 748.00 Sent to Cement Industries 2 Spent Carbon 103.00 Sent to Cement Industries 3 Solvent Distillation Residue 117.00 Sent to Cement Industries 4 Inorganic Waste 405.00 Sent to TSDF 5 MEE Salts 1805.00 Sent to TSDF 6 ETP Sludge 30.00 Sent to TSDF 7 Used Oils 500 L/Annum SPCB Authorized Agencies

for Reprocessing/Recycling 8

Detoxified Containers 500 No’s / Month

After Detoxification sent back to suppliers/SPCB Authorized Parties

9 Used Lead Acid Batteries 4 No’s/ Annum Send back to suppliers for buyback of New Batteries

Solid Waste Details 10 Coal ash from boiler 7050.00 Sent to Brick Manufacturers

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 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) “A” of schedule –I of the notification.



4.0 Site Analysis

4.1 Connectivity

Ortin Laboratories Ltd., Unit- II is located at Sy No: Parts of 300 & 301, Malkapur

(V), Choutuppal (M), Nalgonda (Dt), Telangana State

The nearest habitation from the site is Hyderpur ( Shivanenipadu) at a

distance of 1.6 Km (N).

The nearest railway station is Bibinagar Railway Station at a distance of 19.8

KMs from the site (N).

The nearest airport is Rajiv Gandhi International Airport at a distance of 41.00

KM.

The Nearest road ways NH 9 – 1.9 Km.

4.2 Land Form, Land use and Land ownership.

Ortin laboratories Ltd is an existing unit. There would be no any change in Land Use,

Land Cover or Topography of plot. Green belt will be developed in 33 % area.

4.3 Existing Infrastructure. Project is a located very nearer to NH 9 ( NH 9 – 1.9 KM) and the city is located (i.e

Hyderabad -35.00 Kms) and the basic infrastructure is already there. The plant is

well connected with Road and Railway facilities

4.4 Soil classification

The soil comprises of red soil, black soil, alkaline soil and alluvium. The red soil

constitutes 85 % of the area. Black soil is found over the limestone area, in the

southeastern part of the area. Alkaline soil occurs as limited patches in the central

part. Alluvial soil occurs along Alair, Musi and Kargal rivers.

4.5 Climatic data from secondary sources.

Temperature Maximum: 39.5o C Minimum: 11.6 o C

Normal annual rainfall 674.00 mm 4.6 Social Infrastructure available.

Well developed social infrastructure facilities are available at nearby Habitations.



5.0 Planning Brief

Proposed expansion activities will be started after getting statutory clearance form

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

Further 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

The infrastructure and other facilities are already well developed in nearby Mandal

head quarter and other villages.

6.2 Residential Area

The employees who will work in the industry will be living in nearby Choutuppal or

Hyderabad & there no proposal for creating residential area for employees.

6.3 Green Belt: 33 % of Green Belt will be developed and it will be maintained. 6.4 Social Infrastructure: Facilities like road and communication are good; Banks, ATM's and medical facilities are also adequate in the area. Amenities: Education- schools including middle, secondary and higher secondary schools,

social welfare hostels are available and technical education colleges are plenty in the

nearby areas.

Medical and Health- Community Health Centre, & Primary Health center Are available near village and also there is a ESI dispensary in nearby Village. 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 NH9, South Central railways etc.



6.5 Water management

Water requirement will be met through Ground water . 6.6 Sewerage System:

Domestic waste water will be disposed off through soak pit system.

6.7 Industrial Waste Management: The Hazardous waste sent to TSDF.

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

Expansion activities will be started after getting statutory clearance from concerned

authorities. The project will be completed within two years.

This Expansion will provide benefits to the local people in terms of sustainable

development in terms of economical and social welfare.

The project cost for proposed Project is 20.00 Crores will be used for constructing

additional building, Equipments, Machinery, ZLD System and Air pollution control

Equipments.

TABLE 8.1: PROJECT COST

S. No Particulars Rs. Crores

1 Land 0

3 Plant & Machinery 18.00

4 Working Capital Margin 2.00

Total 20.00

9.0 Analysis of proposal (Final Recommendations)

Local people will get direct employment. which will in turn develop all the

stakeholders.

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 areas under CSR activities.

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