Shares of Bajaj Healthcare Ltd rose 1.5% to a dayβs high of Rs 506.45 on 6th October after the company announced that it had received approval from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to conduct Phase III clinical trials of Suvorexant Tablets in India. The trials will cover tablet strengths of 5 mg, 10 mg, 15 mg, and 20 mg.
Bajaj Healthcare has become the first company in India to receive regulatory clearance for Suvorexant, a prescription drug for treating insomnia in adults. The drug works on the central nervous system to regulate the sleep-wake cycle, helping patients fall asleep and stay asleep.
The Phase III clinical trials will evaluate the drugβs safety, effectiveness, and tolerability across a wider patient base. This is the final stage before submitting to the regulatory authorities. If successful, the company will apply for marketing approval in select markets and move toward a commercial launch.
Managing Director Anil Jain said the SECβs recommendation is an encouraging step and highlighted Bajaj Healthcareβs strong R&D and GMP-compliant manufacturing, adding that the company is committed to bringing high-quality CNS solutions to patients worldwide.
At 3:30 PM, the shares of Bajaj Healthcare ended 0.010% lower at Rs 484 on NSE.
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