Lupin gets 6 USFDA observations for Somerset facility
Mumbai: Lupin has announced that the US Food and Drug Administration (U.S. FDA) has concluded a Pre Approval Inspection with an issuance of a Form-483 with six observations at the Company’s Somerset, New Jersey manufacturing facility.
The inspection was conducted from May 7, 2024 to May 17, 2024.
"We are addressing the observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe," the Company stated.
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.
Read also: Lupin bags USFDA nod for Midostaurin Capsules for Leukemia treatment
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 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin bags USFDA nod for Midostaurin Capsules for Leukemia treatment
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