USFDA concludes inspection of Unichem

Agency, New Delhi
13/09/2013   0 Comments

Drug firm Unichem Laboratories on Friday said the US health regulator has concluded inspection of its Roha facility in Maharashra without making any observations.

The United States Food and Drug Administration (USFDA) conducted inspection at the company's active pharmaceutical ingredients facility at Roha from September 9-12, 2019. The inspection was a post-approval inspection and successfully concluded without any USFDA form 483 being issued, Unichem Laboratories said in a regulatory filing.

A form 483 is issued by the USFDA to notify a company's management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.

Shares of Unichem Laboratories were trading 2.63 per cent higher Rs 183.50 apiece on the BSE.


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