Bajaj Healthcare Becomes First Company in India to Launch Cenobamate Tablets After Receiving DCGI Approval
Bajaj Healthcare Limited has announced a significant milestone, securing 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. This regulatory clearance makes the company the first in India to launch Cenobamate.The approval covers manufacturing and marketing of Cenobamate API and the tablets across six specified strengths: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. The achievement follows the recommendation from the Subject Expert Committee (SEC) of the CDSCO (Neurology & Psychiatry), a matter previously communicated by the company on June 26, 2026.
Cenobamate is described as a next-generation antiseizure medication designed for the treatment of partial-onset seizures in adults. Clinical studies supporting the drug have demonstrated high seizure-freedom rates and significant seizure reduction among patients dealing with inadequately controlled epilepsy, positioning it as an important new option in epilepsy care.
The launch strengthens Bajaj Healthcare Limited's presence in the Central Nervous System (CNS) segment. Mr. Anil Jain, Managing Director of Bajaj Healthcare Limited, commented on the achievement, stating that the DCGI approval underscores the company's commitment to developing differentiated and high-value pharmaceutical products. He noted that Cenobamate is an important addition to their CNS portfolio, offering a meaningful opportunity for sustainable long-term growth as they focus on market penetration.
Bajaj Healthcare Limited, established in 1993, is a leading manufacturer of APIs, Intermediates, and Formulations. The company operates state-of-the-art manufacturing facilities designed to meet the requirements of global markets and serves customers across Europe, the USA, Australia, the Middle East, and South America.
BAJAJHCARE Stock Price Movement
Shares of Bajaj Healthcare Limited slipped by 0.52% on Wednesday, settling at ₹327.45 in the market. The stock was traded 77,004 times during the session, finishing just above its intraday low of ₹323.35.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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