The US Food and Drug Administration (USFDA) inspected the drug maker's Somerset, New Jersey, U.S.A. manufacturing facility from 2 January to 13 January 2023.
The inspection closed with issuance of a Form-483 with two observations, the pharmaceutical company said.
We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance with utmost importance and are committed to be compliant with current good manufacturing practice (CGMP) standards across all our facilities, Lupin stated in the press release.
Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It 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.
On consolidated basis, Lupin reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as against Rs 4,003.42 crore in Q2 FY22.
Shares of Lupin were down 0.11% to Rs 754.75 on the BSE.
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