Lupin announces resolution of USFDA warning letter for Goa, Pithampur facilities

Mumbai: Global pharma major Lupin Limited has announced that it has received correspondence from the US FDA that it has now addressed the concerns raised in the Warning Letter for its facilities in Goa and Pithampur Unit-2, Indore.

This is after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter that was issued on November 6, 2017.

“We are pleased to be informed by the US FDA that we have addressed the concerns through our corrective actions related to the November 2017 Warning Letter. We are committed to being compliant with good manufacturing practices, and to uphold global quality standards and ensuring the quality of our products,” said Nilesh Gupta, Managing Director, Lupin.

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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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The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

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