Bajaj Healthcare gets DCGI approval to manufacture, market Cenobamate API, Tablets

Bajaj Healthcare has received approval from the Drugs Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Cenobamate API and Cenobamate Tablets in strengths of 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.

With this regulatory approval, Bajaj Healthcare becomes the first company to launch Cenobamate in India, marking a significant milestone in the company's journey towards bringing advanced therapies to patients and further strengthening its presence in the Central Nervous System (CNS) segment.

The approval follows the recommendation of the Subject Expert Committee (SEC) for grant of approval for the manufacture and marketing of Cenobamate Tablets, as previously communicated by the Company through its press release dated 26th June 2026.

Cenobamate is a next-generation antiseizure medication indicated for the treatment of partial-onset seizures in adults. Clinical studies have demonstrated significant seizure reduction and high seizure-freedom rates in patients with inadequately controlled epilepsy, supporting its potential as an important treatment option in the evolving landscape of epilepsy care.

Bajaj Healthcare mainly focuses on development, manufacturing and supply of Amino Acids, Nutritional Supplements and Active Pharmaceutical Ingredients (API) for Pharmaceutical, Nutraceuticals and Food industries.