Lupin gets 4 USFDA observations for Tarapur facility

Written by Ruchika Sharma Published On 2022-04-06T11:16:59+05:30 | Updated On 6 April 2022 11:16 AM IST

Lupin gets 4 USFDA observations for Tarapur facility

Mumbai: Drugmaker, Lupin, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with four observations at the company's Tarapur manufacturing facility.

The inspection was carried out between March 22, 2022 and April 4, 2022.

"We are confident of addressing the observations to the U.S. FDA's satisfaction. We are committed to adherence and full compliance with CGMP regulations and uphold the highest quality standards across our manufacturing sites," the company said in a BSE filing.

Lupin had earlier received 13 observations from the USFDA after an inspection at its US-based wholly-owned subsidiary Novel Laboratories, Inc.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions.

The company spacializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.

Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Read also: Lupin joins hands with Alvion to commercialize Cardiometabolic medicines in Southeast Asia

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751