FDA Gives Lupin Clean Bill of Health After Facility Inspection

 Lupin is a leading pharmaceutical company globally, reported that the United States Food and Drug Administration (USFDA) conducted an inspection of its injectable facility in Nagpur. The inspection concluded with no observations, as per the company's filing on the BSE, i.e., Bombay Stock Exchange (BSE).

The USFDA issues a Form 483 to company management after inspections when inspectors identify conditions that they believe may violate the Food, Drug, and Cosmetic Act or other regulations. These observations indicate possible significant regulatory violations. From June 10 to June 13, 2024, the Nagpur facility underwent inspection by the US drug regulator from June 10 to June 13, 2024.The Nagpur inspection follows the issuance of a Form 483 by the USFDA, which included six observations. This occurred subsequent to a pre-approval inspection of Lupin's Somerset, New Jersey manufacturing facility in May 2024. In April of the same year, the USFDA also conducted a good manufacturing practices (GMP) inspection at Lupin's API manufacturing facility in Dabhasa.

Nilesh Gupta, managing director of Lupin, expressed satisfaction with the successful USFDA inspection at their Nagpur injectable facility, noting there were no observations. He said in a statement “This reflects our dedication to upholding the highest quality and compliance standards across our facilities.” Lupin ranks as the third-largest pharmaceutical company in the United States based on prescription volume. In the fiscal year 2024, the company allocated 7.8% of its revenue towards research and development.

Currently, the company operates fifteen manufacturing sites and seven research centers globally. It develops and sells various branded and generic drugs, biotechnology products, and APIs in more than 100 markets spanning the United States, India, South Africa, Asia-Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.