Drug maker Ajanta Pharma Ltd on Wednesday (August 30) said it has received the final approval from the United States Food and Drug Administration (USFDA) for marketing topiramate extended-release capsules in strengths of 25 mg, 50 mg, 100 mg, and 200 mg.
This approval marks a significant addition to Ajanta Pharma's expanding portfolio and reinforces its commitment to delivering quality generic medications to the market. Topiramate, in its extended-release form, is the generic counterpart of Supernus Pharmaceuticals Inc's Trokendi XR. It is used to treat seizures in people with epilepsy and prevent migraine.
Notably, this approval comes as a result of a settlement with the innovator, allowing Ajanta Pharma to potentially launch topiramate on or before February 1, 2026, contingent on specific circumstances.
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The company has secured a total of 50 final Abbreviated New Drug Application (ANDA) approvals, with 41 of them already in commercial production. Additionally, Ajanta holds two tentative approvals and has 22 ANDAs awaiting US FDA clearance.
Shares of Ajanta Pharma Ltd ended at Rs 1,730.75, up by Rs 5.85, or 0.34 percent on the BSE.
