By: IPP Bureau
Last updated : October 31, 2022 10:31 am
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
USFDA has inspected Lupin Limited Nagpur Unit-2 injectable manufacturing facility from October 17, 2022 to October 29, 2022 and issued Form-483.
The inspection was a Pre-Approval Inspection of the injectable facility. The inspection closed with issuance of a Form-483 with five observations.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US.
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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally.