Lupin Mandideep facility successfully concludes USFDA inspection

Published On 2023-08-14 05:59 GMT   |   Update On 2023-08-14 14:50 GMT

MumbaiGlobal pharma major Lupin Limited has announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U.S. FDA).

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.

“We are pleased to announce that the U.S. FDA inspection of our Mandideep Unit-2 facility concluded with no observations. This further reaffirms our commitment to superior quality and compliance standards,” said Nilesh Gupta, Managing Director, Lupin.

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

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, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centres.
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