Bajaj Healthcare Gets CDSCO Nod for Phase III Trials of Insomnia Drug Suvorexant

Bajaj HealthCare Limited (BHL) has become the first Indian company to receive a positive recommendation from the CDSCO’s Subject Expert Committee to conduct Phase III clinical trials for Suvorexant Tablets—a prescription drug for treating adult insomnia. The trials will evaluate the drug’s efficacy, safety, and tolerability in strengths of 5 mg to 20 mg. This milestone marks a key step toward potential marketing approval in India and global markets. Suvorexant works by modulating the sleep-wake cycle, addressing unmet needs in CNS disorders. Managing Director Anil Jain highlighted the company’s strong R&D and GMP-compliant manufacturing capabilities as key enablers. The stock rose 0.62% to ₹482.60 post-announcement. Established in 1993, BHL manufactures APIs, formulations, and nutraceuticals, with a presence in the US, Europe, Australia, and beyond. This development reinforces its growing focus on innovative neurology solutions and strengthens its position in the global specialty pharma space.