Wednesday, 7 December 2016

Sun Pharma says US finds more concerns at Halol plant

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Sun Pharmaceutical Industries Ltd , India's largest drugmaker, said on Wednesday the US health regulator has informed the company of more concerns found at its Halol manufacturing plant after a recent inspection. The approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plant in the western Indian state of Gujarat. A warning letter issued by the US Food and Drug Administration (FDA) last year over violations found at the plant has already been hurting the company's sales. 

The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on Dec. 1, the company said. Such a notice is issued when the FDA finds that conditions at a drug plant violate US rules. It is unclear what violations the FDA found. Sun did not disclose them, and the FDA does not typically make such findings public.

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