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.
Read also: Lupin gets 13 observations by USFDA for its Novel Laboratories
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.
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