Jubilant Life Sciences receives ANDA approvals for bupropion hydrochloride tabs

Jubilant Life Sciences, an integrated pharmaceuticals and life sciences company has received Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (US FDA) for bupropion hydrochloride extended-release tablets USP (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline’s antidepressant Wellbutrin SR(R) and bupropion hydrochloride extended-release tablets USP (SR), 150 mg, the generic version of GlaxoSmithKline’s smoking cessation aid, Zyban(R).

The current total market size for these products as per IMS is $ 518 million per annum. As on June 30, 2013, Jubilant Life Sciences had a total of 649 filings for formulations of which 189 have been approved in various regions of the world. This includes 58 ANDAs filed in the US and 41 dossier filings in Europe.

EP News Bureau – Mumbai