Bajaj HealthCare Limited (BHL) has achieved a significant milestone in its pharmaceutical development journey. The company has received a positive recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to conduct Phase III clinical trials for Suvorexant Tablets in India.

Key Highlights

• Bajaj Healthcare is the first company in India to receive regulatory clearance for Suvorexant
• The drug will be tested in tablet strengths of 5 mg, 10 mg, 15 mg, and 20 mg
• Suvorexant is a prescription medication used to treat insomnia in adults
• Phase III trials will assess efficacy, safety, and tolerability before regulatory submission

Trial Details and Future Plans

The upcoming Phase III trials represent a crucial step in Bajaj Healthcare's drug development process. These trials will evaluate Suvorexant's effectiveness and safety profile in a diverse patient population. Upon successful completion, the company plans to seek marketing authorization in select markets, paving the way for commercial launch.

Management Commentary

Mr. Anil Jain, Managing Director of Bajaj Healthcare Limited, expressed confidence in the company's capabilities, stating, "We are encouraged by the SEC's recommendation and remain committed to advancing Suvorexant through the final stages of clinical development. With our robust R&D infrastructure and GMP-compliant manufacturing capabilities, we are confident in our ability to deliver high-quality, impactful CNS solutions to patients worldwide."

About Suvorexant

Suvorexant is a prescription medication designed to treat insomnia in adults. It works by modulating the sleep-wake cycle through the central nervous system, promoting improved sleep onset and maintenance.

Market Response

The market responded positively to this development, with Bajaj Healthcare shares closing at ₹482.60, up 0.62%.

Company Overview

This approval marks a significant step for Bajaj Healthcare in addressing unmet medical needs in chronic and lifestyle-related disorders, particularly in the field of neurology. The company's focus on developing innovative solutions in the pharmaceutical sector continues to drive its growth and market position.

Bajaj HealthCare Limited (BHL) has set September 19, 2025, as the record date for determining shareholder eligibility for the final dividend payment for the fiscal year 2024-25. This announcement comes as part of the company's commitment to rewarding its shareholders.

Dividend Details

The company has proposed a final dividend of ₹1.00 per equity share, representing a 20% dividend on the face value of the shares. This dividend payout is subject to approval at the upcoming Annual General Meeting (AGM) of the company.

Key Points

• Record Date: September 19, 2025
• Proposed Dividend: ₹1.00 per equity share (20%)
• Paid-up Capital: ₹15,79,16,260.00

Eligibility Criteria

Shareholders who hold Bajaj Healthcare Limited's equity shares as of the record date will be eligible for the dividend payment, provided it receives shareholder approval at the AGM.

Regulatory Compliance

The company has made this announcement in compliance with Regulation 42 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The information has been communicated to both the BSE Limited and the National Stock Exchange of India Limited.

Bajaj Healthcare's decision to declare a dividend reflects the company's financial performance for the fiscal year 2024-25 and its commitment to creating value for its shareholders. Investors and stakeholders are advised to mark the record date in their calendars and await further updates regarding the Annual General Meeting, where the final approval for the dividend will be sought.