Panacea Biotech slumps 5% after US FDA issues 9 observations on Baddi facility

The USFDA inspected the unit from October 03-12.

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Shares of Panacea Biotech slumped around 5 percent intraday on October 13 after the US Food and Drug Administration slapped a Form 483 with nine observations on its biologics manufacturing plant in Baddi.

The US drug regulator issues observations when it finds objectionable practices in a facility under inspection. If the lapses are of a greater degree, the site in question may be classified as Official Action Indicated (OAI), which will prevent the company from filing or exporting any drugs from the facility.

If lapses are not so severe, the US FDA may just issue a Voluntary Action Indicated (VAI) classification, which does not block the way to file and export drugs from the unit.

However, buying from lower levels helped the stock come off its day’s low. At 12.17pm, shares of Panacea Biotech were trading 2 percent lower at Rs 168.60 on the NSE.

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The company informed exchanges that the US FDA conducted an inspection of its material wholly owned subsidiary, Panacea Biotec Pharma Limited at Baddi, Himachal Pradesh. The inspection was conducted from October 3 to 12.

The company said that it will address the issues within the stipulated time.

Panacea Biotec is biotechnology company doing research and development, manufacturing, sales, distribution and marketing of pharmaceutical products and vaccines. The company was set up in 1984 as a private company. It got publicly listed on the NSE in September 1995 as Panacea Biotec Ltd.

The company has US FDA-approved pharmaceutical manufacturing facility at Baddi, and WHO pre-qualified facilities for vaccine production at Lalru (Punjab) and Baddi (Himachal Pradesh).

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