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    Biocon receives 2 USFDA observations for API unit in Bengaluru

    Biocon receives 2 USFDA observations for API unit in Bengaluru

    Biocon receives 2 USFDA observations for API unit in Bengaluru
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    By CNBC-TV18  IST (Published)

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    The drug regulator conducted a post-approval and GMP inspection of the company’s small molecules API manufacturing facility in Bengaluru between February 20 and 26, 2020.

    The United States Food and Drug Administration (USFDA) has issued a Form 483 with two observations to Biocon’ Bengaluru API facility.
    The drug regulator conducted a post-approval and GMP inspection of the company’s small molecules API manufacturing facility in Bengaluru between February 20 and 26, 2020.
    “At the conclusion of the inspection the agency issued a Form 483, with two observations, which are procedural in nature,” Biocon said in a regulatory filing on Thursday.
    The company said that it would respond to the drug regulator with a corrective and preventive action plan in a timely manner.
    “We remain committed to global standards of quality and compliance,” the company’s spokesperson said in the statement.
    The shares of Biocon fell 1.49 percent to Rs 294.24 on the BSE at 9:20 am.
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