Shilpa Medicare continues to fall despite US FDA relief for Hyderabad unit

This was the second US FDA inspection of the facility, which tests drugs, raw material and packing materials, within a year

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Shilpa Medicare was trading lower for the third consecutive session on May 22 even after the US Food and Drug Administration’s voluntary action indicated (VAI) status for the pharma company’s Hyderabad facility.

The VAI inspection classification indicates that the US health regular will not take or recommend regulatory or enforcement action.

“The US Food and Drug Administration (US FDA) GMP (good manufacturing practice) inspection performed on company’s analytical services division in Unit 7 in Nacharam at Hyderabad has been cleared with a status of ‘voluntary action indicated (VAI)’,” Shilpa Medicare said in its filing to exchanges. The inspection was held from March 8 to 10, 2023, with the issuance of two observations.

This was the second US FDA GMP inspection of the facility within a year. The facility is identified as the testing laboratory in numerous ANDAs (abbreviated new drug applications) filed by the company and its agreed parties.

It is involved in analytical testing of drug products, drug substances, raw materials and packing materials, the company said. This unit has started the testing of US, EU & other market commercial batches.

At 2.14 pm, the stock was trading at Rs 245.60 on the NSE, down 1.6 percent, down 4 percent in three days.