Zydus Gets CDSCO Panel Nod for Phase III Trial of Dextromethorphan, Phenylephrine Cough Syrup FDC
Written By : Susmita Roy
Published On 2025-10-06 14:29 GMT | Update On 2025-10-06 14:29 GMT
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New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Zydus Healthcare Limited to conduct a Phase III clinical trial for its fixed-dose combination syrup containing Dextromethorphan Hydrobromide IP 10 mg and Phenylephrine Hydrochloride IP 5 mg per 5 ml.
The decision follows the Committee’s earlier recommendation dated July 9, 2025, after which Zydus Healthcare presented their proposal along with revised Phase III clinical trial protocol before the committee.
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