Bajaj Healthcare receives DCGI approval to launch Cenobamate in India
Bajaj Healthcare Limited received DCGI approval to manufacture and market Cenobamate API and Tablets. This makes it the first company to launch the drug in India, strengthening its CNS portfolio. The approval covers multiple strengths of the API and tablets.
Receiving approval for a new drug, especially being the first in the market, is a significant event that can lead to substantial revenue growth and market share expansion.
The company received regulatory approval to launch a new drug, which is a positive development for its business and market presence.
Bajaj Healthcare Limited (BHL) has received 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 in various strengths (12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg). This makes BHL the first company to launch Cenobamate in India, a significant development for its Central Nervous System (CNS) segment.
The approval follows a recommendation from the Subject Expert Committee (SEC) and is a continuation of the company's earlier intimation on June 26, 2026. Cenobamate is an advanced antiseizure medication used for treating partial-onset seizures in adults.
Mr. Anil Jain, Managing Director of Bajaj Healthcare Limited, stated, “We are extremely pleased to announce that Bajaj Healthcare is the first company to launch Cenobamate in India. The DCGI approval for Cenobamate API and Tablets reflects our continued commitment to developing and bringing differentiated, complex and high-value pharmaceutical products to the Indian market. This achievement also demonstrates the strength of our integrated API and formulation capabilities. Cenobamate represents an important addition to our CNS portfolio and provides us with an opportunity to contribute to the availability of an advanced treatment option for patients suffering from epilepsy. We are now focused on taking the product to the market and building Cenobamate as an important addition to our pharmaceutical portfolio. We believe this launch will further strengthen our CNS franchise and create a meaningful opportunity for sustainable long-term growth for Bajaj Healthcare.”
Bajaj Healthcare Limited, established in 1993, is a manufacturer of APIs, Intermediates, and Formulations, serving markets globally.
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