The US Food and Drug Administration (USFDA) inspected the drug maker's Nagpur Unit-2 injectable manufacturing facility from 17th to 29th October 2022.
The inspection was a Pre-Approval Inspection of the injectable facility. The inspection closed with issuance of a Form-483 with five observations."We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S," Lupin said in a statement.
Mumbai-based Lupin 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 net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.
Shares of Lupin fell 0.95% to Rs 696.40 on Friday, 28 October 2022.
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