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.
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Few brands of Rosuvastatin include Intas Pharma's ARVAST tab, Alkem's JUPIROS tab, Lupin's NOVASTAT tab, Cipla's ROSULIP tab etc.
At a recent SEC meeting for Cardiovascular & Renal, dated 08.12.2021 and 09.12.2021 the committee extensively reviewed Sun Pharma's proposal for manufacturing and marketing Rosuvastatin Sprinkle Capsules 10 mg/20mg/40mg.
After detailed deliberation, the committee recommended for grant of permission for manufacture and marketing of Rosuvastatin Sprinkle Capsules 10 mg/20mg/40mg.
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