An active pharmaceutical ingredient is a component of a drug or biological product. The term is also used to describe a bulk active substance. In pharmaceuticals, active ingredients are often referred to as the “active” part of the formula. These compounds are also known as “biologically active substances” or “active substances.” However, there are differences between biologically active products and pharmaceuticals. To understand the differences between natural products and biologics, let’s look at some of the common uses of active ingredients.
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APIs are usually made from several different chemicals, such as amines and glucuronides. The production of APIs is governed by Good Manufacturing Practices (GMPs). The ICH Q7 Guideline, established by the International Conference on Harmonization, sets minimum standards for the manufacture of active ingredients.
The India active pharmaceutical ingredients market is estimated to be valued at US$ 19,993.2 million in 2021 and is expected to exhibit a CAGR of 8.3% during the forecast period (2021-2028).
Government initiatives to boost production of APIs is expected to propel growth of India active pharmaceutical ingredients market. For instance, in June 2021, Government of India approved four waitlisted firms under the Production Linked Incentive scheme for domestic manufacturing of bulk drugs and Active Pharmaceutical Ingredients (APIs).
Stringent regulatory scenario is expected to restrain growth of India active pharmaceutical ingredients market. With increasing demand for generic drugs, the European Union had updated their policies for import of APIs. According to the new policies, API exporters must comply with the good manufacturing practice (GMP) standards used by the EU, as stipulated by the International Conference for Harmonisation (ICH Q7).
Major players operating in India active pharmaceutical ingredient market, include Aurobindo Pharma Limited, ASolution Pharmaceuticals Pvt. Ltd., Aarti Drugs Ltd., Century Pharmaceuticals Ltd., Chiral Drugs Pvt Ltd., Divi’s Laboratories Ltd., Hikal Ltd., Neuland Labs, Proventus Life Sciences Pvt Ltd, Dr. Reddy’s Laboratories, Lupin Limited, Sun Pharmaceutical Industries Limited, Solara, Teva Pharmaceutical Industries Ltd., and USV Private Limited.
Major players operating in India active pharmaceutical ingredient market are focused on adopting merger and acquisition strategies to expand their product portfolio. For example, PAG, a private equity company, and its grouping partners CX Partners and Samara Capital, in October 2020, agreed to buy a controlling position in Anjan Drug Pvt. Ltd., a maker of APIs.
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By Product Type:
- Low Potent APIs
- High Potent APIs
By Molecule Type:
- Dextromethorphan Hydrobromide
- Afatinib dimaleate
- Bosentan Monohydrate
- Atorvastin Calcium
- Atorvastin Calcium
- Oseltamivir – Process A
- Lanthanum Carbonate Octa
- Sevelamer Carbonate
- Succinyl Choline Chloride
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Table of Content
Chapter 1 Industry Overview
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 India Active Pharmaceutical Ingredients Market Size Analysis from 2022 to 2028
11.6 COVID-19 Outbreak: India Active Pharmaceutical Ingredients Industry Impact
Chapter 2 India Active Pharmaceutical Ingredients Competition by Types, Applications, and Top Regions and Countries
2.1 India Active Pharmaceutical Ingredients (Volume and Value) by Type
2.3 India Active Pharmaceutical Ingredients (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 India Active Pharmaceutical Ingredients Sales, Consumption, Export, Import by Regions (2017-2022)
Chapter 5 Company Profiles and Key Figures in India Active Pharmaceutical Ingredients Business
Chapter 6 Global India Active Pharmaceutical Ingredients Market Forecast (2022-2028)
Chapter 7 Conclusions
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