Sun Pharma Gets CDSCO panel Nod To Manufacture, Market Sitagliptin, Metformin, Glimepiride antidiabetic FDC
New Delhi: Based on the Phase III clinical trial report and bioequivalence (BE) study report of the antidiabetic fixed-dose combination (FDC) drug containing Sitagliptin Phosphate Monohydrate plus Metformin Hydrochloride Monohydrate plus Glimepiride Tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to drug major Sun Pharma to manufacture and market the proposed FDC.
This came after the drug major Sun Pharma presented its proposal along with the Phase III clinical trial report and BE study report before the committee.
Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high. Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.
Metformin is a biguanide class of antihyperglycemic agent that acts primarily by decreasing endogenous hepatic output of glucose by inhibition of gluconeogenesis. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients with type II diabetes.
Glimepiride is a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with insulin or another oral medicine such as metformin. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.
At the recent SEC meeting for Endocrinology and Metabolism held on the 22nd and 23rd of August 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma along with the Phase III clinical trial report and BE study report of the FDC antidiabetic drug Sitagliptin Phosphate Monohydrate plus Metformin Hydrochloride Monohydrate plus Glimepiride Tablet.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the proposed FDC.
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