Lupin gets 5 USFDA observations for Pune biotech facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-10-07 06:00 GMT | Update On 2024-10-07 06:00 GMT
Mumbai: Lupin has announced that the US Food and Drug Administration (U.S. FDA) has completed a Pre-Approval Inspection with five observations at the Company's Biotech facility located in Pune, India.
The inspection was carried out from September 25, 2024 to October 4, 2024.
"The Company is addressing the observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe," Lupin stated in a BSE filing.
Lupin Limited is a global pharmaceutical company 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 enjoys a strong position 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, along with a dedicated workforce of over 22,000 professionals.
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