Akum Pharmaceutical gets CDSCO nod for BE study of FDC Bempedoic acid,Rosuvastatin
New Delhi: Pharmaceutical major, Akum Pharmaceutical has got go ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence study of Bempedoic acid 180mg/180mg/180mg /180mg plus Rosuvastatin calcium eq. to Rosuvastatin 5mg/10mg/20mg/40m g tablets for the treatment of high LDL-cholesterol conditions.
This nod is subjected to the condition that the firm should include Glomerular Filtration Rate (GFR) in the study.
Rosuvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis. Rosuvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low density lipoprotein (LDL) receptors which increases hepatic uptake of LDL. Rosuvastatin also inhibits hepatic synthesis of very low density lipoprotein (VLDL). The overall effect is a decrease in plasma LDL and VLDL.
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