Ajanta Pharma bags USFDA nod for migraine drug Topiramate ER

Written by Ruchika Sharma Published On 2023-08-31T11:54:24+05:30 | Updated On 31 Aug 2023 11:54 AM IST

Ajanta Pharma bags USFDA nod for migraine drug Topiramate ER

Mumbai: 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.

Topiramate is the generic version of Supernus Pharmaceuticals Inc’s Trokendi XR. It is used for the treatment of seizures in people with epilepsy and to prevent migraine.

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.

Ajanta Pharma is a speciality pharmaceutical formulation company having major focus on branded generic business across India, Asia & Africa. The company has a ground presence in each of these 30+ countries.

The company’s state-of-the-art R&D centre is located in Mumbai. The company has 7 world-class manufacturing facilities located in India. For the last 5 financial years, the company has posted healthy performance with its Revenue from Operations growing at 16% CAGR and net profit at 11% CAGR.

Read also: Ajanta Pharma Gets CDSCO Panel Nod To Manufacture, Market Tadalafil Oral Jelly for Erectile Dysfunction

Ajanta PharmaAjanta Pharma newsUSFDATopiramate Extended Release CapsulesSupernus PharmaTrokendi XRepilepsymigraine

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751