Lupin files 8 ANDAs with US FDA in Q4

08 May 2013 Evaluate

Lupin has filed 8 Abbreviated New Drug Applications (ANDA) with United States Food and Drugs Administration (US FDA) in Q4FY13.

The company’s subsidiary - Lupin Pharmaceuticals Inc, in April this year, received final approval for its Pirmella 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/ 0.035mg, 0.75mg/ 0.035mg and 1mg/0.035mg) and Pirmella 1/35 tablets (Norethindrone and Ethinyl Estradiol Tablets USP1mg/0.035mg) from the US FDA to market a generic version of Janssen Pharmaceuticals, Inc’s Ortho-Novum 7/7/7 tablets and Ortho-Novum 1/35 tablets.

The company, on consolidated basis, the group’s net profit after taxes, minority interest stood at Rs 1314.16 crore for the FY13 as compared to Rs 867.65 crore in FY12, up by 51.46%. Groups’s total income has increased by 36.24% to Rs 9669.15 crore for the year under review from Rs 7097.26 crore for the previous year.

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