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    Biocon shares fall as USFDA issues Form 483 for Bengaluru facility

    Synopsis

    Biocon said that the observations are procedural in nature.

    Pharma 1 - GettyGetty Images
    “We remain committed to global standards of quality and compliance,” the company’s spokesperson said in the statement.
    Biocon shares fell 1.49 percent to Rs 294.24 on the BSE after observations were issued by the US regulatory authority for its API facility in Bengaluru.

    The United States Food and Drug Administration (USFDA) issued a Form 483 with two observations to Biocon’ Bengaluru API facility.

    Biocon said that the observations are procedural in nature.

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

    The company said that they are confident of addressing it expeditiously and 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.

    Earlier USFDA issued five observations to Biocon’s another facility after the drug regulatory authority conducted a Pre-Approval Inspection (PAI) and GMP inspection of Biocon’s API manufacturing facility in Bengaluru from January 20 to January 24.



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    (What's moving Sensex and Nifty Track latest market news, stock tips and expert advice, on ETMarkets. Also, ETMarkets.com is now on Telegram. For fastest news alerts on financial markets, investment strategies and stocks alerts, subscribe to our Telegram feeds .)

    Download The Economic Times News App to get Daily Market Updates & Live Business News.

    Subscribe to The Economic Times Prime and read the Economic Times ePaper Online.and Sensex Today.

    Top Trending Stocks: SBI Share Price, Axis Bank Share Price, HDFC Bank Share Price, Infosys Share Price, Wipro Share Price, NTPC Share Price

    ...more
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