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www.fdanews.com/articles/159737-cdsco-moves-to-categorize-fdc-drugs-for-manufacturers-importers

CDSCO Moves to Categorize FDC Drugs for Manufacturers, Importers

October 18, 2013
India’s Central Drugs Standard Control Organization has issued a guideline on the approval of fixed-dose combination drugs. The guideline creates four FDC categories and provides information drugmakers should include in their product applications.
International Pharmaceutical Regulatory Monitor