Unichem Labs successfully completes USFDA inspection of Pithampur facility

"The United States Food and Drug Administration (USFDA) conducted an inspection at the Company's Pithampur, Active Pharmaceutical Ingredients (APIs) facility from September 2, 2019, to September 5, 2019," said Unichem in a filing.

Mumbai: Drug firm Unichem Laboratories recently said the US health regulator has concluded inspection of its Active Pharmaceutical Ingredients (APIs) facility in Pithampur without making any observations.

The inspection was a post-approval inspection and was conducted from September 2, 2019, to September 5, 2019. United States Food and Drug Administration (USFDA) successfully concluded the inspection without any FDA form 483 issued.

"The United States Food and Drug Administration (USFDA) conducted an inspection at the Company's Pithampur, Active Pharmaceutical Ingredients (APIs) facility from September 2, 2019, to September 5, 2019," said Unichem in a filing.

Read Also: Unichem gets USFDA nod for Solifenacin Succinate tablets to treat overactive bladder

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.

Read Also: Ghaziabad formulations facility gets 1 USFDA observation: Unichem Laboratories