United States Food and Drug Administration (USFDA) has inspected Lupin’s Mandideep Unit-1 facility from November 14, 2022 to November 23, 2022. The inspection of the facility closed with issuance of a Form 483 with eight observations each for the drug product facility and API facility at the site.
The company is committed to addressing the observations and will work with the USFDA to resolve these issues at the earliest. The company is uphold quality and compliance issues with utmost importance and remain committed to be compliant with cGMP quality standards across all our 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.
