Sun Pharma secures CDSCO panel nod for Dextromethorphan Hydrobromide, Chlorpheniramine maleate FDC
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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Dextromethorphan Hydrobromide & Chlorpheniramine maleate drug combination is used to relieve throat inflammation that triggers coughing, sneezing, and a runny nose.
Dextromethophan, an antitussive agent, is primarily used as a cough suppressant to relieve cough caused by mild throat and bronchial inflammation (such as that which often occurs with the flu and common cold), as well as cough caused by inhaled particle irritants.
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