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USFDA for voluntary action by Sun Pharma’s on Halol plant observations


USFDA for voluntary action by Sun Pharma’s on Halol plant observations

New Delhi: US health regulator USFDA has said it found objectionable conditions at Sun Pharmaceutical Industries’ Halol plant in Gujarat but did not recommend any action against the company.

The development led to a surge in the share price of the pharma major, which closed 8.13 percent higher at Rs 528.20 on BSE.

In a notification on its website, the US Food and Drug Administration said it has issued Voluntary Action Indicated (VAI) status to the company’s plant.

According to the USFDA, VAI means “Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action…”

In February, the USFDA had issued three observations after inspecting the facility. The company had said it was preparing the response to the observations.

Sun Pharma had received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat in end of 2015.

This followed the inspection of the facility in September 2014 by FDA inspectors.



Source: PTI
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