Lupin gets one USFDA observation for Aurangabad facility
Mumbai: Lupin has announced that the Company received Form-483 with one observation from the US Food and Drug Administration (USFDA) at the conclusion of the inspection at the manufacturing facility in Aurangabad.The facility was inspected from March 6 to March 15, 2024."The inspection closed with the issuance of a Form-483 with one (1) observation. We are confident of addressing the...
Mumbai: Lupin has announced that the Company received Form-483 with one observation from the US Food and Drug Administration (USFDA) at the conclusion of the inspection at the manufacturing facility in Aurangabad.
The facility was inspected from March 6 to March 15, 2024.
"The inspection closed with the issuance of a Form-483 with one (1) observation. We are confident of addressing the concern raised by the U.S. FDA and will resolve the same at the earliest. We uphold quality and compliance with utmost importance and are committed to comply with CGMP quality standards across all our facilities," Lupin stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
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