Lupin gets 17 USFDA observations for Pune facility
"The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility," Lupin stated.
Mumbai: Drugmaker, Lupin, has recently announced that the US Food and Drug Administration (USFDA) has conducted a Prior-Approval Inspection at the company's Biotech manufacturing facility in Pune, India in October 2022.
The inspection concluded with the issuance of a Form 483 with seventeen observations.
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.
"We are committed to addressing the concerns raised by the U.S. FDA expeditiously," the company said in a recent BSE filing.
"The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility," Lupin stated.
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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.
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