The USFDA has inspected Lupin’s Nagpur Unit-2 injectable manufacturing facility from October 17, 2022 to October 29, 2022. 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 U.S.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.