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Glenmark Pharma gets final approval from USFDA for Estradiol Vaginal

17 Sep 2018 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Estradiol Vaginal Inserts USP, 10 mcg, the generic version of VAGIFEM 1, 10 mcg, of Novo Nordisk Inc.

According to IQVIA sales data for the 12 month period ending July 2018, the VAGIFEM, 10 mcg market achieved annual sales of approximately $286.3 million. Glenmark’s current portfolio consists of 139 products authorized for distribution in the US marketplace and 61 ANDA’s pending approval with the USFDA.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).

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