NSEGranting/withdrawal/surrender/cancellation/suspension of key licenses/ regulatory approvals5d ago · 12 Aug 2026, 04:41 pm

Granting/withdrawal/surrender/cancellation/suspension of key licenses/ regulatory approvals

Bajaj Healthcare Limited · BAJAJHCARE

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Bajaj Healthcare Limited has received approval from the Drug Controller General of India (DCGI) to manufacture and market Cenobamate API and Tablets in six strengths, marking a significant milestone in the Company's journey towards bringing advanced therapies to patients.

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Earnings Impact6/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

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Bajaj Healthcare Limited has informed the Exchange about Granting/withdrawal/surrender/cancellation/suspension of key licenses/ regulatory approvals

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BAJAJHCARE_12082026163655_Reg_30_Intimation_for_approval_from_DCGI_Final.pdf

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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.