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Glenmark Pharmaceuticals Receives USFDA Approval for Topiramate Capsules

Glenmark Pharmaceuticals Ltd announced on Wednesday that it has received the final approval from the US Food & Drug Administration (USFDA) for its generic Topiramate capsules used in the treatment of certain types of seizures. The approval is specifically for Topiramate capsules with strengths of 15 mg and 25 mg, according to a statement released by the company.

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Impact on Market and Growth Potential

Glenmark’s Topiramate capsules in strengths of 15 mg and 25 mg have been deemed by the FDA as bioequivalent and therapeutically equivalent to Topamax capsules by Janssen Pharmaceuticals, Inc. These capsules will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.

The Topamax Capsules, 15 mg, and 25 mg market had recorded annual sales of approximately USD 21.9 million as per IQVIA™ sales data for the 12-month period ending in May 2024. This approval is expected to further bolster Glenmark Pharmaceuticals’ market presence and revenue generation capabilities.

Strategic Initiatives for Future Growth

Glenmark Pharmaceuticals currently boasts a portfolio of 198 products authorized for distribution in the US marketplace, with 50 ANDAs (Abbreviated New Drug Applications) pending approval from the USFDA. The company is actively seeking external development partnerships to complement and expedite the expansion of its existing pipeline and product portfolio, showcasing its commitment to sustained growth and innovation in the pharmaceutical industry.

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