Piramal Pharma falls 5% after FDA lists 3 observations on US facility

Shares of Piramal Pharma Limited traded 5 percent lower at Rs 132 in morning trade on February 8 after the company announced that its Riverview facility in the US underwent inspection by the Food and Drug Administration (US FDA) from January 29 to February 6.

“On conclusion of the inspection, a Form-483 was issued with three observations. The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity. The company is preparing a detailed response to the observations, which will be submitted to the US FDA within stipulated timelines,” the company said in a regulatory filing.

At 9:40am, the stock was trading at Rs 137, down 1.2 percent from the previous close on the NSE. The counter has gained almost 20 percent in the last three months.

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Despite the regulatory inspection, Piramal Pharma reassured stakeholders that the observations were classified under the Voluntary Action Indicated (VAI) category and did not involve issues related to data integrity. “We remain committed to maintaining the highest standards of compliance and will work with the agency to comprehensively address all the observations,” it said.

The Form 483 observations function as a regulatory tool for the US FDA to convey concerns related to adherence to good manufacturing practices (GMP) at pharmaceutical facilities.

For the October-December quarter, the company turned profitable by posting a consolidated net profit of Rs 10 crore for the third quarter ending December 2023. In the same period of the previous fiscal year, the Mumbai-based pharmaceutical firm had reported a net loss of Rs 90 crore.

Its revenue from operations increased to Rs 1,959 crore for the third quarter, compared to Rs 1,716 crore a year back, according to Piramal Pharma’s regulatory filing.

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