Jubilant Pharmova Roorkee facility placed under USFDA import alert

By ruchikaPublished On 2021-07-16T10:30:53+05:30 | Updated On 2021-07-16T16:24:58+05:30

Jubilant Pharmova Roorkee facility placed under USFDA import alert

The products that get impacted due to the import alert contributed to less than 3% of FY21 total revenues for the Company.

Noida: Jubilant Pharmova Limited (JPM), has recently announced that U.S. Food and Drug Administration (USFDA) has issued import alert for Roorkee dosage formulations facility in the agency's recent inspection.

The inspection of the facility was conducted in March 2021, the company said in a filing

Earlier, the Roorkee facility received an OAI in December 2018 and then a Warning Letter in March 2019.

The Company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.

The agency has exempted Meclizine tablets, Olanzapine orally disintegrating tablets, Risperidone orally disintegrating tablets, Spironolactone tablets, and Valsartan tablets from the import alert subject to the Company meeting a few conditions.

The products that get impacted due to the import alert contributed to less than 3% of FY21 total revenues for the Company.

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.