Glenmark Pharmaceuticals has received the final approval from the United States Food & Drug Administration (USFDA) for its Topiramate Capsules USP, 15 mg and 25 mg, used to treat epilepsy and seizures, the company informed stock exchanges on July 17.
The FDA determines Topiramate capsules USP as bioequivalent and therapeutic equivalent to a drug by Janssen Pharmaceuticals. As per the latest IQVIATM sales data, the market for Topamax capsules has clocked an annual sales of approximately $21.9 million.
Glenmark Pharma’s current US portfolio has 198 products authorized for distribution, and 50 ANDAs pending approval by USFDA.
Shares of Glenmark Pharma are higher by 65 percent so far this year and have doubled in the past one year.
The company reported widening of consolidated net loss to Rs 1,238.6 crore for the March quarter from a net loss of Rs 549.4 crore in the same period a year ago.
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