Lupin says FDA raises concerns over plant in central India

Indian drugmaker Lupin Ltd said on Monday that the U.S. Food and Drug Administration (FDA) has raised concerns over production processes at the company's Pithampur plant in central India. The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement, without giving details. Lupin said it has received one drug approval and two site-transfer approvals from the same plant since the FDA audit.



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