CDSCO Clarifies Approval Pathway for Formulation Intermediates, Modified Release Granules and Pellets
The Central Drugs Standard Control Organization (CDSCO) has issued a major clarification regarding the regulatory approval process for formulation intermediates, including directly compressible granules, taste-masked granules, modified-release granules, pellets, and similar intermediates used in pharmaceutical manufacturing. The clarification aims to establish uniform licensing practices across India and eliminate confusion among manufacturers.












