active pharma ingredients (api) trityl chloride 20 tons/month

ACTIVE PHARMA INGREDIENTS (API) [TTCL]

[EIRI/EDPR/4571] J.C.: 2788XL 

INTRODUCTION

The Indian pharmaceutical industry has been on an upward trajectory over the past few decades, contributing around 1.72 per cent of the GDP of the nation. The Indian pharma industry is anticipated to reach $ 65 bn by 2024 and $ 130 bn by 2030. This growth is driven by the increasing demand for affordable and high-quality medicines, both domestically and internationally. Currently, India is the 3rd largest producer by volume and 14th largest by value worldwide. Indian pharma exports witnessed a growth of 103 per cent since 2013-14 – from INR 90, 415 Crores in 2013-14 to INR 1,83,422 Crores in 2021-22. About 20% of the global exports in generic drugs are met by India, thereby making India “Pharmacy of the World”.

India’s API Industry

Active Pharmaceutical Ingredient (or API) is a crucial segment of the pharma industry, contributing to around 35 per cent of the market. API is the biologically active component of a drug that causes an intended medical effect. According to World Health Organization, API is any substance or combination of substances used in a finished pharmaceutical product (or FPP) intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to have an immediate impact in restoring, correcting, or modifying physiological functions in human beings.

India is the 3rd largest producer of API accounting for an 8 per cent share of the Global API Industry. 500+ different APIs are manufactured in India, and it contributes 57 per cent of APIs to prequalified list of the WHO. The Indian API market is anticipated to increase at a CAGR of 13.7 per cent during the first four years – about 8 per cent higher than the generic API industry. The Indian API space has become lucrative for several investors and venture capitalists. India’s robust domestic market, advanced chemical industry, skilled workforce, stringent quality and manufacturing standards, and low costs (about 40 per cent less than that in the West) for setting up and operating a modern plant give an added advantage.

The growing antagonism between the West and China has also pushed the global pharma majors to source more from countries other than China. India’s emergence as the alternate source of bulk drugs has been quite remarkable. 

Some of the major players operating in the India active pharmaceutical ingredient market include Solara, Aurobindo Pharma Limited, Dr. Reddy's Laboratories, Lupin Limited, Sun Pharmaceutical Industries Limited, Divi’s Laboratories Ltd., Aarti Drugs Ltd., Neuland Labs, Century Pharmaceuticals Ltd., and Proventus Life Sciences Pvt Ltd. among others.

Government of India’s Schemes and Initiatives

To capitalize on its API potential, India is building a holistic and conducive ecosystem. In 2020, the government approved INR 6,940 crore for a production-linked incentive (PLI) scheme for the promotion of domestic manufacturing of Key Starting Materials (KSMs)/Drug Intermediaries (DIs), and APIs. Manufacturing of 35 active pharmaceutical ingredients – representing about 67 per cent of APIs for which India has 90 per cent import dependence – has already started in India under the PLI scheme. The Department of Pharmaceuticals has also given "in-principle" approval to proposals from the states of Himachal Pradesh, Gujarat, and Andhra Pradesh under the "Promotion of Bulk Drug Parks" scheme. This is a crucial initiative to support bulk drug manufacturing in India. The scheme, with a budget of INR 3000 crores, provides financial aid to these three states for the creation of bulk drug parks with the objective of reducing the cost of manufacturing bulk drugs by establishing world-class common infrastructure facilities and increasing the competitiveness of the domestic bulk drug industry. The Government of Assam has also proposed a Pharmaceutical Park in Chaygaon, Kamrup Rural on a land area of 100 acres with an estimated project cost of INR 153.64 crores.

Furthermore, to promote innovation within the industry, various measures have been proposed such as raising the limit for foreign direct investment (up to 100 per cent, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects) and implementing a new strategy for protecting intellectual property rights.

In 2022, India's pharmaceutical business underwent a tremendous transformation, moving from being a volume producer to a valued supplier. Post-COVID-19, the Indian pharma sector has gained momentum as a key player in the global markets. India sets to double its API market in the next 3 years, says Saurabh Mukherjee, Founder and Chief Investment Officer of Marcellus Investment Managers. Cutting-edge research and development in the production of generic APIs would only be possible with the proper regulatory support—through PLI schemes and other incentives—combined with trained, high-skilled individuals. With the ongoing efforts, India is well-positioned to become a global leader in the pharmaceutical industry.

COST ESTIMATION

Plant Capacity            0.8 MT/Day  

Land & Building (4000 sq.mt.)    Rs. 1.89 Cr    

Plant & Machinery                    Rs. 3.05 Cr 

Working Capital for 1 Months    Rs. 1.65 Cr 

Total Capital Investment          Rs. 7.01 Cr 

Rate of Return                          31%

Break Even Point                      59%

CONTENTS

INTRODUCTION

INDIA’S API INDUSTRY

GOVERNMENT OF INDIA’S SCHEMES AND INITIATIVES

ALPHA-LIPOIC ACID

AZITHROMYCIN

KETOPROFEN

PREGABALIN

PROPERTIES AND APPLICATION OF TRITYL CHLORIDE

CHEMISTRY AND MANUFACTURERS OF API

CHEMISTRY

MANUFACTURERS

CARBIDOPA API

DILTIAZEM

PRECAUTIONS

GEMFIBROZIL API

THERAPEUTIC EFFECTS

PRECAUTIONS AND TOXICITIES

DRUG INTERACTIONS

AZITHROMYCIN API

TREATMENT

MECHANISM OF ACTION

SIDE EFFECTS

ACTIVE PHARMA INGREDIENTS

APIS ARE GENERALLY MANUFACTURED THROUGH A VARIETY OF PROCESSES THAT INCLUDE:

MARKET OVERVIEW OF TRITYL CHLORIDE

KEY TAKEAWAYS

API MARKET ANALYSIS

INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET ANALYSIS

INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) INDUSTRY SEGMENTATION

INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET GROWTH

ONCOLOGY SEGMENT EXPECTS TO REGISTER A HIGH CAGR

INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) INDUSTRY BULLISH INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET KEY LEADERS INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET NEWS 

CURRENT SITUATION OF API IN INDIA

KEY INTERMEDIATES/ KSMS FROM CHINA HAVING HIGH DEMAND IN INDIA

CHALLENGES FACED BY THE INDIAN API INDUSTRY

STRICTER IMPLEMENTATION OF POLLUTION CONTROL NORMS:

INTERPRETATION OF DPCO, 2013

NO TAX INCENTIVES, HIGHER UTILITIES AND BORROWING COST

LACK OF MEGA BULK DRUG PARKS

ISSUES FACED BY FERMENTATION INDUSTRY

HIGH DEPENDENCE ON A SINGLE SOURCE CAN HAVE A CASCADING EFFECT RECOMMENDATIONS TO REVIVE THE INDIAN API INDUSTRY

RECOMMENDATIONS

IMMEDIATE

LONG TERM

RECOMMENDATIONS – IMMEDIATE

1. FASTER ENVIRONMENT CLEARANCE

2. ENCOURAGE MANUFACTURING BY PROVIDING A FISCAL STIMULUS

FOR APIS AND INTERMEDIATES

FOR FERMENTATION PRODUCTS

3. ACCOMMODATIVE PRICING POLICY UNDER DPCO, 2013

4. FINANCIAL INCENTIVES

RECOMMENDATIONS – LONG TERM

1. DEVELOP LARGE CLUSTERS AND PROVIDE PLUG-AND-PLAY INFRASTRUCTURAL SUPPORT IN DEDICATED ZONES FOR MANUFACTURING APIS

2. INDUSTRY–ACADEMIA INITIATIVES

3. FACILITATE ALTERNATIVE SOURCES OF IMPORT

GLOBAL OVERVIEW OF API

USES AND APPLICATION OF NAPROXEN

PEOPLE USE NAPROXEN FOR THE FOLLOWING CONDITIONS:

DOSAGE AND FORM OF NAPROXEN

MILD TO MODERATE PAIN

OSTEOARTHRITIS, RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS

ACUTE GOUT ATTACKS

JUVENILE RHEUMATOID ARTHRITIS

HEADACHES

BRIEF DESCRIPTION OF PROCESSES INVOLVED IN API

MANUFACTURING PROCESS OF TTCL [TRITYL CHLORIDE]

RAW MATERIAL REQUIRED/MONTH

MANUFACTURING PROCESS OF AZITHROMYCIN

CHEMICAL REACTION

MATERIAL OR MASS BALANCE

MANUFACTURING PROCESS OF PREGABALIN

STAGE- I

STAGE-II

STAGE-III

PROCESS FLOW DIAGRAM

MATERIAL BALANCE OF PREGABALIN

STAGE-I

STAGE-II

STAGE-III

MANUFACTURING PROCESS OF NAPROXEN

STAGE-I

STAGE-II

STAGE-III

STAGE-IV

STAGE-V

STAGE-VI

STAGE-VII

PROCESS FLOW DIAGRAM

RAW MATERIALS

MANUFACTURING PROCESS OF ALPHA LIPOIC ACID

STAGE-1

STAGE-II

STAGE-III

MANUFACTURING PROCESS OF KETOPROFEN

STEP-I

STEP-II

OTHER PROCESS OF API MANUFACTURE

MANUFACTURING PROCESS OF M-BROMO ANISOLE

REACTION

PROCESS FLOW DIAGRAM OF M-BROMO ANISOLE (BATCH 400 KGS)

MANUFACTURING PROCESS OF ETHYL TRIPHENYL PHOSPHONIUM BROMIDE (BATCH 135 KG)

PROCESS FLOW DIAGRAM (BATCH 135 KG)

MANUFACTURING PROCESS OF CINNAMYLALDEHYDE (BATCH 560 KG)

PROCESS FLOW DIAGRAM

MANUFACTURING PROCESS OF M-PHENOXY BENZYL ALCOHOL (BATCH 175 KG)

PROCESS FLOW DIAGRAM BATCH-175 KG

MANUFACTURING OF BENZYL ALCOHOL BATCH- 187 KGS

PROCESS FLOW DIAGRAM

MATERIAL BALANCE

DISTILLATORY

MANUFACTURING PROCESS OF ALPRAZOLAM

PROCESS FLOW DIAGRAM

MANUFACTURING PROCESS OF METHYLPHENIDATE

PROCESS FLOW DIAGRAM

GOVERNMENT APPROVAL REQUIREMENTS FOR API

EFFLUENT TREATMENT IN API

ENVIRONMENT, HEALTH AND SAFETY (EHS):

THE FOLLOWING TRAININGS SHALL BE THE IMPARTED TO EACH AND EVERY EMPLOYEE:

PRESENT MANUFACTURES OF API (TTCL)

PRINCIPLES OF PLANT LAYOUT

STORAGE LAYOUT:

EQUIPMENT LAYOUT:

SAFETY:

PLANT EXPANSION:

FLOOR SPACE:

UTILITIES SERVICING:

BUILDING:

MATERIAL-HANDLING EQUIPMENT:

RAILROADS AND ROADS:

MAJOR PROVISIONS IN ROAD PLANNING FOR MULTIPURPOSE SERVICE ARE:

PLANT LOCATION FACTORS

PRIMARY FACTORS

1. RAW-MATERIAL SUPPLY:

2. MARKETS:

3. POWER AND FUEL SUPPLY:

4. WATER SUPPLY:

5. CLIMATE:

SPECIFIC FACTORS

6. TRANSPORTATION:

A. AVAILABILITY OF VARIOUS SERVICES AND PROJECTED RATES

7. WASTE DISPOSAL:

8. LABOR:

9. REGULATORY LAWS:

10. TAXES:

11. SITE CHARACTERISTICS:

12. COMMUNITY FACTORS:

13. VULNERABILITY TO WARTIME ATTACK:

14. FLOOD AND FIRE CONTROL:

EXPLANATION OF TERMS USED IN THE PROJECT REPORT

1. DEPRECIATION:

2. FIXED ASSETS:

3. WORKING CAPITAL:

4. BREAK-EVEN POINT:

5. OTHER FIXED EXPENSES:

6. MARGIN MONEY:

7. TOTAL LOAD:

8. LAND AREA/MAN POWER RATIO:

PROJECT IMPLEMENTATION SCHEDULES

INTRODUCTION

PROJECT HANDLING

PROJECT SCHEDULING

PROJECT CONSTRUCTION SCHEDULE

TIME SCHEDULE

ADDRESSES OF RAW MATERIAL SUPPLIERS

ADDRESSES OF PLANT AND MACHINERY SUPPLIERS

APPENDIX – A:

01. PLANT ECONOMICS

02. LAND & BUILDING

03. PLANT AND MACHINERY

04. OTHER FIXED ASSESTS

05. FIXED CAPITAL

06. RAW MATERIAL

07. SALARY AND WAGES

08. UTILITIES AND OVERHEADS

09. TOTAL WORKING CAPITAL

10. TOTAL CAPITAL INVESTMENT

11. COST OF PRODUCTION

12. TURN OVER/ANNUM

13. BREAK EVEN POINT

14. RESOURCES FOR FINANCE

15. INSTALMENT PAYABLE IN 5 YEARS

16. DEPRECIATION CHART FOR 5 YEARS

17. PROFIT ANALYSIS FOR 5 YEARS

18. PROJECTED BALANCE SHEET FOR (5 YEARS)