The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for the manufacture and marketing of Cenobamate Tablets in strengths of 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg, the company said.
Cenobamate is a next-generation antiseizure medication developed for the treatment of partial-onset seizures in adults. Cenobamate offers an innovative approach to seizure management.
ALSO READ | Bajaj Healthcare Q4 results: Swings to profit, revenues up 15.4%
Clinical studies have demonstrated significant seizure reduction and high seizure freedom rates in patients with inadequately controlled epilepsy, making it an important advancement in the evolving landscape of epilepsy treatment.
Anil Jain, Managing Director, Bajaj Healthcare Limited, said, “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 commercialise the product, while further strengthening Bajaj Healthcare’s position in the specialty pharmaceuticals segment.”
ALSO READ | Bajaj Healthcare Q3 profit rises 34% YoY on strong revenue and margin expansion
Fourth Quarter Results
Bajaj Healthcare Ltd reported a net loss of ₹22.9 crore in the fourth quarter of FY26, compared with a net profit of ₹11.2 crore in the corresponding period last year. Revenue from operations declined 0.9% year-on-year to ₹143.6 crore from ₹156.3 crore.
The company’s Earnings Before Interest, Taxes, Depreciation, and Amortisation (EBITDA) rose 93% year-on-year to ₹22.7 crore from ₹11.8 crore, while EBITDA margin improved to 14.8% from 7.6% in the year-ago period.
The board has recommended a final dividend of 30% of the face value of ₹5 each, translating to ₹1.50 per equity share for FY26, subject to shareholder approval at the upcoming annual general meeting.
ALSO READ | Bajaj Healthcare gets CDSCO nod for phase III trials of suvorexant tablets for insomnia
On Thursday (June 25), shares of Bajaj Healthcare Ltd ended at ₹302.40, down by ₹9.05, or 2.91%, on the BSE.
