Bajaj Healthcare gets CDSCO panel nod for Phase III trials for anti-seizure drug
"With this, Bajaj Healthcare aims to provide a safe and effective treatment option for epilepsy patients in India," the Company stated.
Mumbai: Bajaj Healthcare Limited has announced that it has received a recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to conduct Phase III clinical trials for Cenobamate Tablets in strengths of 12.5mg, 25mg, 50mg, 100mg, 150mg, and 200mg.
Cenobamate is an advanced anti-seizure medication used for the treatment of partialonset seizures in adults. It functions by regulating excessive neuronal activity, significantly reducing seizure frequency and improving patient outcomes.
"With this regulatory milestone, Bajaj Healthcare aims to provide a safe and effective treatment option for epilepsy patients in India," the Company stated.
Phase III clinical trials are the final stage of drug development before regulatory approval. These large-scale trials will evaluate the efficacy, safety, and tolerability of Cenobamate Tablets in a diverse patient population. Upon successful completion of the study, Bajaj Healthcare will seek final approval for commercial launch in the Indian market. The API will also be manufactured by the Company.
Speaking at the occasion Anil Jain, Managing Director, Bajaj Healthcare Limited, said, “We are delighted with this approval from the SEC and look forward to proceeding with the required activities in due course time. Backed by our R&D capabilities and manufacturing infrastructure, we are hopeful to bring Cenobamate to the Indian market. With the rising demand for innovative and effective epilepsy treatments, we remain committed to addressing this critical need with high-quality pharmaceutical solutions.”
Bajaj Healthcare Limited is a Manufacturer of APIs, Intermediates and Formulations. Established in the year 1993, it specializes in manufacturing of intermediates, API, formulations & Nutraceuticals. The Company has state-of-art manufacturing facilities of APIs, intermediates and formulations. These facilities are designed to meet the requirements of both advanced as well as emerging market opportunities. BHL has a strong presence globally in countries like Europe, USA, Australia, Middle East and South America.
