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Bajaj Healthcare secures SEC-CDSCO nod for Phase III Clinical Trials of Suvorexant Tablets
Oct-04-2025

Bajaj Healthcare has received a positive recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to initiate Phase III clinical trials for Suvorexant Tablets, available in strengths of 5mg, 10mg, 15mg, and 20mg. The company is the first company in India to receive this regulatory nod for Suvorexant. Suvorexant is a prescription medication used to treat insomnia in adults. It works by modulating the sleep-wake cycle through the central nervous system, promoting improved sleep onset and maintenance.

The upcoming Phase III trials will evaluate the efficacy, safety, and tolerability of Suvorexant in a diverse patient population, representing the final and most crucial step before regulatory submission. Upon successful completion, the company aims to pursue marketing authorization in select markets, paving the way for its commercial launch.

Bajaj Healthcare mainly focuses on development, manufacturing and supply of Amino Acids, Nutritional Supplements and Active Pharmaceutical Ingredients (API) for Pharmaceutical, Nutraceuticals and Food industries.

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