Ghaziabad formulations facility gets 1 USFDA observation: Unichem Laboratories

Unichem said it will provide the response and corrective action plan within the next 15 working days to address the USFDA observation for its formulations facility at Ghaziabad.

New Delhi: Drug firm Unichem Laboratories on Monday said the US health regulator has issued one observation after the inspection of its formulations facility at Ghaziabad.

"The United States Food and Drug Administration (USFDA) conducted an inspection at the company's Ghaziabad formulation facility between August 19, 2019, to August 23, 2019. The inspection was a routine Good manufacturing practice (GMP) surveillance," Unichem said in a regulatory filing.

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"At the end of the inspection, the facility received one observation which is not a repeat observation and is procedural in nature," the company added.

Unichem said it will provide the response and corrective action plan within the next 15 working days to address the USFDA observation.

Founded in 1944 by Padmabhushan Amrut V Mody, Unichem Labs is currently active in Finished Formulations, APIs, Contract Manufacturing, Custom Synthesis etc. Their RnD Site at Goa has expertise in product development, process chemistry and developing complex APIs for the global market.

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