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Jubilant Life Sciences, Lupin and Aurobindo Pharma receives US FDA approval for Valsartan tabs

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Jubilant Life Sciences, Lupin and Aurobindo Pharma have received 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.

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 includes72 ANDAs filed in the US and 46Dossier filings in Europe.

Cumulative ANDA filings with the US FDA for Lupin stood at 200 (as of September 30th, 2014) with the company having received 108 approvals to date.

Aurobindo now has a total of 195 ANDA approvals (170 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

EP News BureauMumbai

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