Ajanta Pharma receives USFDA approval for Topiramate capsules

Ajanta Pharma received USFDA approval for Topiramate extended-release capsules. 

The US Food and Drug Administration (USFDA) has given the company the final approval to market the capsules in strengths of 25 mg, 50 mg, 100 mg, and 200 mg.

The generic version of Trokendi XR of Supernus Pharmaceuticals Inc. is topiramate.

According to the settlement with the innovator, the company stated that Ajanta may introduce Topiramate on February 1, 2026, or sooner in specific situations.

A total of 50 final ANDA approvals have been granted to the company, of which 41 have been commercialized. The company additionally holds two tentative approvals, and another 22 ANDAs are seeking USFDA approval.

Ajanta Pharma is a specialty pharmaceutical formulation company with a primary focus on branded generic operations in India, Asia, and Africa.

Source: Media Reports