USFDA inspection: Lupin gets warning letter for Tarapur facility

Published On 2022-09-29 09:00 GMT | Update On 2022-09-29 09:01 GMT

Mumbai: Pharma major, Lupin, has announced that the Company has received a warning letter from the US Food and Drug Administration (USFDA) for the Company's Tarapur, Maharashtra (India) facility.

The USFDA had inspected the Lupin Tarapur site from March 22, 2022 to April 4, 2022.

"The Company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility," Lupin stated in a BSE filing.

"We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities," Lupin added.

Medical Dialogues team had earlier reported that Lupin had received four observations from the US Food and Drug Administration (USFDA) at the conclusion of an inspection at the company's Tarapur manufacturing facility.

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA inspection: Lupin gets warning letter for Tarapur facility

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