Unichem Labs receives zero USFDA observations for Roha facility

The inspection of the active pharmaceutical ingredients facility at Roha was conducted from September 9 to September 12 2019 by the United States Food and Drug Administration (USFDA).

New Delhi: Drug firm Unichem Laboratories recently said the US health regulator has concluded inspection of its Roha facility in Maharashtra without making any observations.

The inspection of the active pharmaceutical ingredients facility at Roha was conducted from September 9 to September 12, 2019, by the United States Food and Drug Administration (USFDA).

"The inspection was a post-approval inspection and successfully concluded without any FDA form 483 issued," Unichem said in a filing.

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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.

Unichem Labs manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. The Company has skills in product development, process chemistry and manufacturing complex API as well as dosage forms.

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