Ajanta Pharma Receives Final Approval From US FDA For Topiramate Extended Release Capsules
Ajanta 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.
Ajanta Pharma Receives Final Approval From US FDA For Topiramate Extended Release Capsules | Image: Ajanta Pharma (Representative)
Ajanta Pharma Limited, a speciality pharmaceutical formulation company, 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, the company on Wednesday annunced through an exchange filing.
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.
Ajanta 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.
About Ajanta Pharma Limited
Ajanta Pharma is a speciality pharmaceutical formulation company having major focus on branded generic business across India, Asia & Africa.
For last 5 financial years, company has posted healthy performance with its Revenue from Operations growing at 16 percent CAGR and net profit at 11 percent CAGR.
Ajanta Pharma Limited shares
The shares of Ajanta Pharma Limited on Wednesday at 3:30pm IST were at Rs 1,731.80, up by 0.41 percent.
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