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Ajanta Pharma Receives Final Approval for Topiramate Extended Release Capsules from USFDA

Ajanta Pharma Receives Final Approval for Topiramate Extended Release Capsules from USFDA

Speciality pharmaceutical formulation firm Ajanta Pharma has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg and 200 mg.

Topiramate is the generic version of Supernus Pharmaceuticals Inc's Trokendi XR™. As per the settlement with the innovator, Ajanta can launch Topiramate on February 1, 2026 or earlier under certain circumstances.

The company has received 50 final ANDA approvals, out of which 41 are commercialized. Ajanta also holds 2 tentative approvals and 22 ANDAs are awaiting US FDA approvals.

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Ajanta Pharma USFDA
More news about: global pharma | Published by Manvi | August - 31 - 2023 | 1131

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