Bajaj Healthcare Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) on December 31, 2025, to conduct clinical trials and bioequivalence study for Suvorexant tablets. This development marks a significant step forward in the company's pharmaceutical development pipeline.

Regulatory Milestone

The CDSCO approval enables Bajaj Healthcare to proceed with clinical testing and bioequivalence studies of Suvorexant tablets, a medication primarily used for treating sleep disorders. This regulatory clearance is essential for pharmaceutical companies seeking to bring new formulations to market, as it allows them to conduct necessary safety and efficacy studies.

Clinical Trial and Bioequivalence Study Significance

Receiving CDSCO approval represents a crucial phase in the drug development process. The approval indicates that the regulatory authority has reviewed and accepted the company's clinical trial protocol, manufacturing standards, and safety parameters for the proposed study. The bioequivalence study component will help establish that the company's formulation performs similarly to existing reference products.

Strategic Development

This approval allows Bajaj Healthcare to advance its research and development efforts in the sleep disorder treatment segment. The company can now initiate the clinical trial and bioequivalence study process, which will generate the necessary data required for eventual market authorization of the Suvorexant tablet formulation.

The CDSCO clearance demonstrates the company's adherence to regulatory standards and its commitment to following proper clinical development pathways for new pharmaceutical products.

Bajaj HealthCare Limited has disclosed an acquisition by its promoter group member Anil Champala Jain, who serves as the company's Managing Director. The acquisition involves 2,000 equity shares purchased through open market transactions on December 10, 2025.

Acquisition Details

The disclosure, filed under Regulation 29(1) of SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 2011, provides details of the transaction and its impact on shareholding patterns.

Shareholding Pattern Changes

The acquisition has resulted in a marginal increase in Anil Champala Jain's shareholding in the company. The detailed shareholding comparison shows the impact of this transaction on his overall stake.

Regulatory Compliance

The transaction demonstrates adherence to regulatory requirements, with the promoter group member fulfilling disclosure obligations under SEBI regulations. The acquisition represents an open market purchase by an existing promoter.

Company Information

Bajaj Healthcare Limited maintains its registered office at Bhoomi Velocity, Wagle Industrial Estate, Thane. The disclosure was formally communicated to stock exchanges as per regulatory requirements.