Active Pharmaceutical Ingredient

An active pharmaceutical ingredient (API) is the substance in a medicine that produces the intended therapeutic effect. APIs—whether chemically synthesised or biologically derived—must comply with Good Manufacturing Practice (GMP) and are regulated by authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Central Drugs Standard Control Organisation (CDSCO) in India. Because APIs determine a drug’s efficacy, quality failures or supply interruptions can trigger global shortages of finished medicines. Quotes Regulatory definitions “Ensuring the health and competitiveness of the API industry is vital to U.S. public health security.” — Thea D. Rozman Kendler, Assistant Secretary of Commerce for Export Administration, press statement announcing a federal assessment of the U.S. API industrial base (9 July 2024).BIS To Conduct Assessment Of U.S. Active Pharmaceutical Ingredient Industrial Base U.S. Department of Commerce, Bureau of Industry and Security 9 July 2024 https://www.bis.gov/press-release/bis-conduct-assessment-u.s.-active-pharmaceutical-ingredient-industrial-base 21 May 2025 Bureau of Industry and Security “We have a significant capacity for medications like Metformin and Clopidogrel and we definitely want to grow our market presence of other APIs.” — Dr. Sanjay Chaturvedi, CEO of IOL Chemicals & Pharmaceuticals, interview with The Financial Express on India’s API supply strategy (15 October 2022).Sushmita Panda 70–80 % of APIs are imported from China; we are working towards filling this gap: Dr. Sanjay Chaturvedi The Financial Express 15 October 2022 https://www.financialexpress.com/business/healthcare-70-80-of-the-apis-are-imported-from-china-we-are-working-towards-changing-this-sanjay-chaturvedi-ceo-iol-chemicals-and-pharmaceuticals-2713038/ 21 May 2025 The Financial Express “The foreign establishments and the domestic establishments are held to the same standards… they are held to the same high standards of FDA requirements.” — Dr. Judith McMeekin, Associate Commissioner for Regulatory Affairs, FDA, in testimony before the U.S. Senate Finance Committee hearing “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process” (2 June 2020).COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process https://www.congress.gov/116/chrg/CHRG-116shrg45640/CHRG-116shrg45640.pdf U.S. Congress Senate Committee on Finance 2 June 2020 21 May 2025 Industry and scientific commentary “Businesses like this don't often come on the market. So I do believe this will affect a significant amount of interest.” — **Richard Francis**, CEO, Teva Pharmaceutical Industries, on plans to divest Teva’s API division (Reuters interview, 20 Feb 2024).Teva Pharm to stay as unified drugmaker, sees big interest in API business, says CEO Steven Scheer Reuters 20 February 2024 https://www.reuters.com/business/healthcare-pharmaceuticals/teva-pharm-stay-unified-generics-branded-drugmaker-ceo-says-2024-02-20/ 21 May 2025 “Shortages adversely impact patients, health care professionals, and health systems. An entire generation of clinicians has never practiced during a time without shortages.” — **Erin Fox**, Senior Director of Drug Information, University of Utah Health, speaking to U.S. lawmakers on drug shortages (ABC News, 22 Mar 2023).Patients, health care providers face shortages of critical drugs, Senate report finds Allison Pecorin & Sony Salzman ABC News 22 March 2023 https://abcnews.go.com/Politics/patients-health-care-providers-face-shortages-critical-drugs/story?id=98018805 21 May 2025 “Our R&D team is dedicated to staying ahead of industry trends by continuously developing innovative solutions like liposomal APIs. This commitment enables us to deliver products that improve patient outcomes and set new benchmarks in the pharmaceutical industry.” — added **Sunil Kumar Agarwal**, Managing Director, West Bengal Chemical Industries Limited (press release, 7 March 2025). https://www.biospace.com/press-releases/wbcil-pioneers-liposomal-apis-transforming-drug-delivery-in-life-sciences See also Pharmaceutical industry References