New Delhi: Approving the proposal for a Phase IV clinical study for Atropine Sulfate Ophthalmic Solution USP 0.05% w/v, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has recommended that Entod Pharmaceuticals Ltd. may conduct the study as per the protocol submitted.

This came after Entod Pharmaceuticals Ltd. presented their proposal to conduct a Phase IV Clinical Study of Atropine Sulfate Ophthalmic Solution USP 0.05% w/v, submitted under Protocol ID: BCREPL-004, Version 1.0 dated 17 July 2024.

Atropine is an alkaloid derived from Atropa belladonna. It is a racemic mixture of d- and l-hyoscyamine, with only l-hyoscyamine being pharmacologically active. Clinically, atropine is available primarily as a sulfate salt and can be

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