Unichem Labs API facility in Kolhapur clears CGMP surveillance by USFDA

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

The USFDA inspection of the Active Pharmaceutical Ingredients (APls) facility was conducted from September 16, 2019, to September 20, 2019.

"The Company's newly commissioned Active Pharmaceutical Ingredients (APls) facility at Kolhapur, Maharashtra was inspected by The United States Food and Drug Administration (USFDA) from September 16, 2019, to September 20, 2019," Unichem said in a filing.

The inspection was successfully completed by the U. S Food and Drug Administration (USFDA) and no observations were issued for the facility.

"The inspection was a CGMP surveillance and pre-approval inspection and was successfully concluded without any FDA form 483 issued, " Unichem added.

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.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities

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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