Ajanta Pharma secures FDA approval for Topiramate Capsules, eyes 2026 market launch

Ajanta Pharma Limited, a leading specialty pharmaceutical formulation company, has won a decisive victory by gaining final approval from the United States Food and Drug Administration (FDA) to market Topiramate Extended-Release Capsules. Available in four different potencies—25 mg, 50 mg, 100 mg, and 200 mg—the Topiramate capsules are the generic version of Supernus Pharmaceuticals Inc’s Trokendi XR.

According to the terms set in a settlement with Supernus Pharmaceuticals, Ajanta Pharma is set to launch Topiramate on February 1, 2026, or potentially earlier under certain conditions. This approval aligns perfectly with Ajanta Pharma’s ongoing mission to bring high-quality, affordable healthcare solutions to market.

Ajanta Pharma continues its strong track record with this latest approval, as the company has now secured 50 final ANDA (Abbreviated New Drug Application) approvals. Out of these, 41 have already been commercialized. Additionally, Ajanta holds 2 tentative ANDA approvals and has 22 ANDAs currently awaiting US FDA approval.

This USFDA approval marks yet another feather in Ajanta Pharma’s cap, adding to its ever-growing portfolio of pharmaceutical offerings. As the company continues to expand its presence in the US market, this latest approval enhances Ajanta Pharma’s reputation as a key player in the specialty pharmaceutical formulation sector.