Bajaj Healthcare Becomes First in India to Secure SEC Recommendation for Cenobamate Tablets

Bajaj Healthcare Becomes First in India to Secure SEC Recommendation for Cenobamate Tablets​

Bajaj Healthcare Limited has achieved a significant regulatory milestone, becoming the first company in India to secure a recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) for its Cenobamate Tablets. The SEC recommended the grant of approval for manufacturing and marketing the tablets in multiple strengths.

The recommended product range includes Cenobamate Tablets in strengths of 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.

Cenobamate is described as a next-generation anti-seizure medication designed for the treatment of partial-onset seizures in adults. The drug offers an innovative approach to seizure management, with clinical studies demonstrating high seizure freedom rates and significant seizure reduction among patients suffering from inadequately controlled epilepsy, marking it as an advancement in epilepsy treatment.

Anil Jain, Managing Director of Bajaj Healthcare Limited, highlighted that this approval constitutes a major regulatory milestone for the company. He stated that the achievement reflects the progress made in developing Cenobamate Tablets and reinforces BHL's commitment to expanding its portfolio of differentiated CNS therapies. Jain added that the company remains well-positioned to commercialize the product while strengthening its presence in the specialty pharmaceuticals segment, working closely with regulatory authorities to obtain necessary approvals.

Bajaj Healthcare Limited is a leading manufacturer specializing in APIs, Intermediates, and Formulations. Established in 1993, the company has built a strong reputation for providing high-quality pharmaceutical products and nutraceuticals across various therapies. BHL operates state-of-the-art manufacturing facilities that cater to both regulated and emerging markets, maintaining a global customer base across Europe, USA, Australia, Middle East, and South America.

BAJAJHCARE Stock Price Movement​

Shares of Bajaj Healthcare Limited slipped by 1.61% on Thursday, settling at ₹304.05 as traders closed positions. The stock traded within a day range between the low of ₹301.1 and the high of ₹315.75, recording a volume of 142,508 shares.