Lupin gets 13 observations by USFDA for its Novel Laboratories
Lupin Ltd on Thursday said the USFDA has issued 13 observations to its US-based wholly-owned subsidiary Novel Laboratories, Inc after an inspection.
New Delhi: Pharma major Lupin Ltd on Thursday said the USFDA has issued 13 observations to its US-based wholly-owned subsidiary Novel Laboratories, Inc after an inspection.
The USFDA (US Food and Drug Administration) has concluded an inspection at the company's wholly-owned subsidiary Novel Laboratories, Inc., based in Somerset, New Jersey. The inspection commenced on March 7, 2022 and concluded on March 30, 2022, Lupin Ltd said in a regulatory filing.
"The inspection closed with thirteen observations. We are confident of addressing these observations and will work closely with the Agency to address their concerns. We uphold quality and compliance with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all our facilities," it said.
The company does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility. The facility contributes less than 5 per cent of the company's global revenues.
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 enjoys a leadership position 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. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue in research and development in FY21.
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