Jubilant receives ANDA approvals for Bupropion Hydrochloride

18 October 2013 | News | By BioSpectrum Bureau

Jubilant receives ANDA approvals for Bupropion Hydrochloride

Jubilant Life Sciences, an integrated pharmaceuticals and life sciences company announced on October 18, 2013 that it has received Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (US FDA) for
One of these products includes Bupropion Hydrochloride Extended-release Tablets USP (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline's antidepressant Wellbutrin SR(R). The other product is 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 US$ 518 Million per annum. The company is expected to launch these products in third quarter of FY 2014.

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 U.S and 41 Dossier filings in Europe.

Jubilant Life Sciences is engaged in manufacture and supply of APIs, Generics, Specialty Pharmaceuticals and Life Science Ingredients. It also provides Services in Contract Manufacturing and Drug Discovery and Development. The Company's strength lies in its unique offerings of Pharmaceutical and Life Sciences products and services across the value chain. With 10 world-class manufacturing facilities in India, US and Canada and a team of over 6,200 multicultural people across the globe, the Company is committed to deliver value to its customers spread across 98 countries.

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