Lupin announced that the United States Food and Drug Administration (USFDA) has completed its inspection of the company’s injectable facility in Nagpur, India, with zero observations. The inspection, conducted from June 10 to June 13, 2024, concluded without any Form 483 observations, indicating full compliance with regulatory standards.
A Form 483 is issued by the USFDA to firm management when investigators observe conditions that may constitute violations of the Food, Drug, and Cosmetic Act and other regulations. The absence of such observations at Lupin’s Nagpur facility highlights the company’s adherence to stringent quality and compliance protocols.
In a regulatory filing on the Bombay Stock Exchange (BSE), Lupin shared the successful outcome of the inspection. Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the results, stating, “This reflects our dedication to upholding the highest quality and compliance standards across our facilities.”
The positive inspection at the Nagpur facility comes shortly after the USFDA issued a Form 483 with six observations following a pre-approval inspection of Lupin’s manufacturing facility in Somerset, New Jersey, in May 2024. Additionally, in April, the USFDA conducted a Good Manufacturing Practices (GMP) inspection of Lupin’s active pharmaceutical ingredients (API) manufacturing facility in Dabhasa.
Lupin, the third-largest pharmaceutical company in the US by prescription volume, invested 7.8 percent of its revenue in research and development in FY24. The company operates fifteen manufacturing sites and seven research centers worldwide, developing and commercializing a wide range of branded and generic formulations, biotechnology products, and APIs.
With operations spanning over 100 markets, including the United States, India, South Africa, the Asia-Pacific (APAC) region, Latin America (LATAM), Europe, and the Middle East, Lupin continues to expand its global footprint while maintaining high standards of quality and compliance.
