Bajaj Healthcare secures SEC recommendation for Cenobamate Tablets

Bajaj Healthcare Limited has become the first company in India to secure a recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Cenobamate Tablets. The SEC (Neurology & Psychiatry) recommended the grant of permission for the drug in strengths of 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. This regulatory milestone allows Bajaj Healthcare to advance the commercialization of a next-generation antiseizure medication designed for the treatment of partial-onset seizures in adults.

The intimation was filed under Regulation 30 of the SEBI (LODR) Regulations, 2015. Cenobamate offers an innovative approach to seizure management, with clinical studies demonstrating significant seizure reduction and high seizure freedom rates in patients with inadequately controlled epilepsy.

Product Details

The following table outlines the specific strengths for which the company received the recommendation:

Strength (mg)	Indication
12.5	Partial-onset seizures in adults
25	Partial-onset seizures in adults
50	Partial-onset seizures in adults
100	Partial-onset seizures in adults
150	Partial-onset seizures in adults
200	Partial-onset seizures in adults

Management Commentary

Anil Jain, Managing Director of Bajaj Healthcare Limited, stated that the approval represents a significant regulatory milestone reflecting the progress made in the development of Cenobamate Tablets. He emphasized that this reinforces the company's commitment to expanding its portfolio of differentiated Central Nervous System (CNS) therapies. The company intends to work closely with regulatory authorities to obtain necessary approvals and is positioned to manufacture and commercialize the product to strengthen its standing in the specialty pharmaceuticals segment.

Bajaj Healthcare Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs), Intermediates, and Formulations. Established in 1993, the company operates manufacturing facilities catering to regulated and emerging markets, serving customers across Europe, USA, Australia, Middle East, and South America.

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
-0.40%	+1.85%	+19.38%	-11.97%	-27.98%	-3.93%

Bajaj Healthcare has approved the sale of its operational business unit situated at Plot No. N-178, MIDC, Tarapur Industrial Area, Boisar, to M/s Orchem Products for a consideration of up to ₹4.05 Cr. The transaction is expected to be completed on or before October 31, 2026, subject to the execution of definitive transaction documents. The Board of Directors approved the sale via a circular resolution passed on June 23, 2026, under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

The Tarapur unit contributed ₹3.31 Cr to the company's revenue, representing 0.54% of the total, and held a net worth of ₹3.97 Cr, or 0.74%, during the last financial year. The buyer, M/s Orchem Products, is not part of the promoter, promoter group, or group companies, confirming that the transaction does not fall within the purview of Related Party Transactions. Furthermore, the sale does not qualify as a slump sale or an undertaking under the Companies Act, 2013.

In compliance with the SEBI (Prohibition of Insider Trading) Regulations, 2015, the trading window for dealing in the securities of Bajaj Healthcare Limited will remain closed for all Directors, Designated Persons, and their immediate relatives. The closure takes effect immediately and will last until 48 hours after the formal execution and signing of the definitive agreements.