Lupin's Mandideep Unit-1 facility gets USFDA observations

The United States Food and Drug Administration (USFDA) inspected the drug maker's Mandideep Unit-1 facility from 14 November to 23 November 2022.

The inspection closed with issuance of a Form 483 with eight observations each for the drug product facility and API facility at the site.

The pharmaceutical company said We are committed to addressing the observations and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with current good manufacturing practice (cGMP) quality standards across all our facilities.

Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The drug maker reported a consolidated net profit of Rs 129.7 crore in Q2 FY23 as against a net loss of Rs 2,098 crore recorded in Q2 FY22. Net sales rose by 2.2% year on year to Rs 4,091.2 crore during the quarter.

Shares of Lupin were down 0.11% to end at Rs 718 on the BSE.

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