Sun Pharma secures CDSCO panel nod for Dextromethorphan Hydrobromide, Chlorpheniramine maleate FDC
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New Delhi: The Subject Expert Committee (SEC) functional under Central Drugs Standard Control Organization (CDSCO) has given its nod to Sun Pharmaceuticals for manufacturing and marketing the fixed-dose combination (FDC) of Dextromethorphan Hydrobromide 30mg and Chlorpheniramine maleate IP 4mg sustained-release Oral suspension.
However, the SEC approval came with the condition that the firm should conduct a Phase-IV clinical trial and, accordingly, the Phase-IV protocol should be submitted within 03 months from the date of approval.
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