Jubilant Life Sciences gets final approval from US FDA for Valsartan Tablets

06 Jan 2015 Evaluate

Jubilant Life Sciences, an integrated Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg, the generic version of Diovan (of Novartis), used as an anti-hypertensive.

The current annualized US market size for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg as per IMS is $2 Billion. As on September 30, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the US and 46 Dossier filings in Europe.

Jubilant Life Sciences is engaged in manufacture and supply of active pharmaceutical ingredient (APIs), solid dosage formulations, radio pharmaceuticals, allergy therapy products and life science ingredients. It also provides services in contract manufacturing of sterile injectables and ointments, creams and liquids and drug discovery and development.

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