Sun Pharma Rosuvastatin Sprinkle Capsules get CDSCO panel okay
New Delhi: Pharmaceutical major, Sun Pharma, has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Rosuvastatin Sprinkle Capsules 10 mg/20mg/40mg.
This approval came after the firm presented the proposal along with the results of bioequivalence (BE) study report for Rosuvastatin Sprinkle Capsules.
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and pharmacokinetic/pharmacodynamic (PK/PD) parameters.
Rosuvastatin is an HMG-CoA reductase inhibitor used to lower lipid levels and reduce the risk of cardiovascular disease including myocardial infarction and stroke. Rosuvastatin selectively and competitively binds to and inhibits hepatic hydroxymethyl-glutaryl coenzyme A (HMG-CoA) reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate, a precursor of cholesterol.
Also Read: Sun Pharma Gets CDSCO Panel Nod To Brinzolamide, Timolol Maleate, Potassium Sorbate FDC
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