Last Updated on December 31, 2023 by The Health Master
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.
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