Date: June 26, 2026
Regulatory Approval Update
Bajaj Healthcare Limited has received a recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) for the grant of permission to manufacture and market Cenobamate Tablets in six strengths: 12.5mg, 25mg, 50mg, 100mg, 150mg, and 200mg.
Product Details
- Cenobamate is a next-generation antiseizure medication developed for the treatment of partial-onset seizures in adults
- The medication offers an innovative approach to seizure management
- Clinical studies have demonstrated significant seizure reduction and high seizure freedom rates in patients with inadequately controlled epilepsy
- This represents an important advancement in the evolving landscape of epilepsy treatment
Management Commentary
Mr. Anil Jain, Managing Director, stated: \"This approval represents a significant regulatory milestone for Bajaj Healthcare. It reflects the progress we have made in the development of Cenobamate Tablets and reinforces our commitment to expanding our portfolio of differentiated CNS therapies. We will continue to work closely with the regulatory authorities towards obtaining the necessary approvals and remain well-positioned to manufacture and commercialize the product, while further strengthening Bajaj Healthcare's position in the specialty pharmaceuticals segment.\"
Company Background
Bajaj Healthcare Limited is a leading manufacturer of APIs, Intermediates and Formulations, established in 1993. The company operates state-of-the-art manufacturing facilities designed to meet requirements of both regulated and emerging markets, serving customers across Europe, USA, Australia, Middle East, and South America.