Glenmark Pharma Gets ANDA Nod for Topiramate Capsules

Glenmark Pharmaceuticals on Wednesday, July 17, said that it received final approval from the United States Food & Drug Administration for Topiramate Capsules USP, 15 mg and 25 mg. 

Key Takeaways from Glenmark Pharma’s Approval for Topiramate Capsules

• Glenmark Pharmaceuticals has received final approval from the US FDA for Topiramate Capsules USP, 15 mg and 25 mg.
• The capsules have been determined as bioequivalent and therapeutically equivalent to Topamax Capsules, 15 mg and 25 mg, of Janssen Pharmaceuticals.
• The approved Topiramate Capsules will be distributed in the US by Glenmark.

Glenmark’s Topiramate Capsules USP, 15 mg and 25 mg has been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax 2 Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, and will be distributed in the US by Glenmark Pharmaceuticals, USA. 

According to IQVIATM sales statistics for the 12-month period ending May 2024, the Topamax Capsules, 15 mg and 25 mg market generated an annual sales of roughly $21.9 million.

About Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Limited is an Indian-based multinational pharmaceutical firm. The Company's strategy is to establish a worldwide formulation company with branded, generic, and over-the-counter (OTC) divisions in dermatological, respiratory, and cancer therapies. The company also has a regional/country-specific presence in other therapeutic areas, including diabetes, cardiovascular disease, and oral contraception. Its product line comprises topical treatments, liquids, respiratory MDI/DPI, complicated injectables and biologics, and oral solids. 

For the treatment of chronic obstructive pulmonary disease, the company offers a bioequivalent form of Tiotropium Bromide dry powder inhaler (DPI) under the trade names Tiogiva in the United Kingdom and Tavulus in Spain. Ryaltris, the Company's first worldwide branded specialty product, is a fixed dosage nasal spray that treats allergic rhinitis by combining an antihistamine (Olopatadine) with a steroid (Mometasone Furoate).

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