United States Food and Drug Administration (USFDA) has inspected Lupin’s Pithampur Unit-2 manufacturing facility from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations.
The company is addressing the observations comprehensively and will work with the USFDA to resolve these issues at the earliest. The company has uphold quality and compliance with utmost importance across all its facilities.
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.