USFDA issues three observations each on API, Finished Product side of Lupin Pithampur facility
Mumbai: Lupin has announced that the United States Food and Drug Administration (USFDA) has issued three observations each on the API and Finished Product side of the Company's Pithampur facility.
The facility was inspection from September 16 to September 27, 2024.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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