Panacea Biotech Shares Dip 5% as US FDA Issues Observations on Manufacturing Plant

13 Oct 2023 , 03:15 PM

Panacea Biotech shares decline by 5% intraday on October 13 due to US FDA issuing a Form 483 with nine observations on its biologics manufacturing plant in Baddi. Form 483 is given by the US drug regulator when objectionable practices are found during an inspection.

Severity of the lapses determines the classification – Official Action Indicated (OAI) for significant issues preventing drug filing or export, or Voluntary Action Indicated (VAI) for less severe problems allowing drug operations to continue.

Panacea Biotech states that it will address the identified issues within the stipulated timeframe. The company, established in 1984, engages in biotechnology, including research, development, manufacturing, and marketing of pharmaceutical products and vaccines. It holds a US FDA-approved pharmaceutical manufacturing facility in Baddi and WHO-pre-qualified facilities for vaccine production in Lalru (Punjab) and Baddi (Himachal Pradesh).

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