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.
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.
Jubilant Pharmova Limited is a company engaged in pharmaceuticals, contract research and development services and proprietary novel drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Therapy Products, Contract Manufacturing of Sterile Injectibles and Non-sterile products, APIs and generics through six USFDA approved manufacturing facilities in the US, Canada and India.
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