Lupin gets zero USFDA observations for Bioresearch Centre in Pune
Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has completed an inspection of its Bioresearch Centre in Pune, India without any observation. Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
"We are pleased to announce that the Lupin Bioresearch Centre has successfully undergone its seventh consecutive onsite inspection, reaffirming our commitment to patient safety and our superior quality and compliance standards," said Nilesh Gupta, Managing Director, Lupin.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas.