BSECompany Update5d ago · 12 Aug 2026, 04:42 pm
The Company has received the approval from DCGI to manufacture and market Cenobamate API and Tablets
Bajaj Healthcare Ltd · 539872
✦ AI Summary▲ PositiveProduct Launch
Bajaj Healthcare Ltd has received approval from the Drug Controller General of India (DCGI) to manufacture and market Cenobamate API and Tablets in six strengths, making it the first company to launch Cenobamate in India.
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Full Announcement
Bajaj Healthcare Ltd - 539872 - Announcement Under Regulation 30 Of SEBI (LODR) Regulations, 2015
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Ref: BHL/STEX 28/2026-27
Date: August 12, 2026
BSE Limited National Stock Exchange of India Limited
Phiroze Jeejeebhoy Towers 5th Floor, Exchange Plaza,
Dalal Street Bandra Kurla Complex Bandra (East)
Mumbai – 400 001 Mumbai-400051
Scrip Code: 539872 Symbol: BAJAJHCARE
Dear Sir/Madam,
Subject: Intimation under Regulation 30 of the SEBI (LODR) Regulations, 2015
This is in reference to our earlier intimation dated June 26, 2026, regarding the recommendation received
from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard
Control Organisation (CDSCO) for the grant of permission to manufacture and market of Cenobamate
Tablets 12.5mg, 25mg, 50mg, 100mg, 150mg & 200mg.
We hereby inform you that the Company has received approval from the Drug Controller General of India
(DCGI), under the Central Drugs Standard Control Organization (CDSCO), for the manufacture and
marketing of Cenobamate API and Cenobamate Tablets in strengths of 12.5 mg, 25 mg, 50 mg, 100 mg,
150 mg and 200 mg.
The press release issued by the Company in this regard is enclosed herewith for your information.
Kindly take the same on record.
Thanking You,
For and Behalf of Bajaj Healthcare Limited
Monica Tanwar
Company Secretary & Compliance Officer
Investor Release
Bajaj Healthcare becomes the first Company to launch Cenobamate in India,
receives DCGI approval to manufacture and market Cenobamate API and
Tablets across six strengths
Mumbai, 12th August 2026: Bajaj Healthcare Limited is pleased to announce that it
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 strengths of 12.5 mg, 25 mg, 50 mg, 100
mg, 150 mg and 200 mg.
With this regulatory approval, Bajaj Healthcare Limited becomes the first company to
launch Cenobamate in India, marking a significant milestone in the Company's journey
towards bringing advanced therapies to patients and further strengthening its
presence in the Central Nervous System (CNS) segment.
The approval follows the recommendation of the Subject Expert Committee (SEC) for
grant of approval for the manufacture and marketing of Cenobamate Tablets, as
previously communicated by the Company through its press release dated 26th June
2026.
Cenobamate is a next-generation antiseizure medication indicated for the treatment
of partial-onset seizures in adults. Clinical studies have demonstrated significant
seizure reduction and high seizure-freedom rates in patients with inadequately
controlled epilepsy, supporting its potential as an important treatment option in the
evolving landscape of epilepsy care.
Commenting on the milestone, Mr. Anil Jain, Managing Director, Bajaj Healthcare
Limited, said: “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.” 1
About Bajaj Healthcare Ltd:
Bajaj Healthcare Limited is a leading manufacturer of APIs, Intermediates and
Formulations. Established in 1993, it has built a strong reputation for delivering high-
quality pharmaceutical products, nutraceuticals across various therapies. The
Company operates state-of-the-art manufacturing facilities that are designed to
meet the requirements of both regulated and emerging markets. With a growing
global presence, BHL serves customers across Europe, the USA, Australia, the Middle
East, and South America.
Contact Details
Investor Relations: MUFG Intime India Pvt.
Bajaj Healthcare Ltd
Ltd.
CIN: L99999MH1993PLC072892 Name: Ms. Prachi Ambre/ Mr. Irfan Raeen
Email: prachi.ambre@in.mpms.mufg.com/
Name: Mr. Anil Jain, MD
irfan.raeen@in.mpms.mufg.com
Link
Email: investors@bajajhealth.com Meeting Request Link – Link
Safe Harbor Statement
Any forward-looking statements about expected future events, financial and operating
results of the Company are based on certain assumptions which the Company does not
guarantee the fulfilment of. These statements are subject to risks and uncertainties.
Actual results might differ substantially or materially from those expressed or implied.
Important developments that could affect the Company’s operations include a
downtrend in the industry, global or domestic or both, significant changes in political
and economic environment in India or key markets abroad, tax laws, litigation, labour
relations, exchange rate fluctuations, technological changes, investment and business
income, cash flow projections, interest, and other costs. The Company does not
undertake any obligation to update forward-looking statements to reflect events or
circumstances after the date thereof.