USFDA issues 6 observations for Jubilant Pharmova Roorkee facility

Noida: Jubilant Pharmova Limited has announced that the United States Food and Drug Administration (USFDA) has recently concluded audit of the Solid Dosage Formulations facility at Roorkee, India of Jubilant Generics, a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited.

The USFDA has issued six observations pursuant to the completion of the audit.

"The company will submit an action plan on the observations and will engage with USFDA for next steps," the company stated in its recent release.

Read also: USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from list of excepted products from import

Medical Dialogues team had earlier reported that Jubilant Pharmova Limited (JPM), had received import alert from the U.S. Food and Drug Administration (USFDA) for Roorkee dosage formulations facility in the agency's inspection.

Read also: Jubilant Pharma arm to raise Rs 3,186 crore loan from Standard Chartered Bank to repay debt