United States Food and Drug Administration (USFDA) has classified Lupin's Pithampur Unit-2 manufacturing facility inspection as Official Action Indicated (OAI). The Company is working with the USFDA to satisfactorily resolve the compliance issues and is committed to be compliant with CGMP standards at all its manufacturing facilities.
The inspection was undertaken by USFDA at Lupin’s Pithampur Unit-2 manufacturing facility from July 8 to July 17, 2025, wherein the inspection was closed with the issuance of a Form-483 with four observations.
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.
