Lupin gets 2 USFDA observations for Aurangabad facility
Lupin gets 2 USFDA observations for Aurangabad facility Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-09-06T11:21:10+05:30 | Updated On 6 Sept 2025 11:21 AM ISTMumbai: Lupin has received two observations from the U.S. Food and Drug Administration (USFDA) at the closure of an inspection at the Company's Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility.The product-specific Pre-Approval Inspection (PAI) was held from September 01 to September 05, 2025."We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities," the company stated in a BSE filing.Read also: Lupin wins USFDA nod for Risperidone for extended-release injectable suspension for schizophreniaLupin 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 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. Read also: Lupin Gets Expert Committee Nod To Conduct Phase I Trial of Certolizumab Pegol, IGRA TB Test Made Mandatorylupinlupin newsUSFDAUSFDA inspectionRuchika SharmaRuchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751Dr. Kamal Kant KohliDr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751Show Full ArticleNext Story