Cipla gets CDSCO panel okay to manufacture, market Metformin, Sitagliptin FDC

New Delhi: Pharmaceutical major, Cipla has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) manufacture and market an anti-diabetic fixed dose combination (FDC) tablet comprising Sitagliptin (50mg/50mg/100) and  Metformin HCl (500mg/1000/1000mg).

This came in the wake of the proposal presented by the drug-maker Cipla for the antidiabetic FDC of Metformin Hydrochloride as an sustained release form and Sitagliptin Phosphate alongwith Bioequivalence study report and justification for clinical trial waiver before the committee.

Metformin is a popular antihyperglycemic agent that belongs to the biguanide class of drugs. Currently, metformin is the drug of choice for the management of type II diabetes. It lowers blood glucose levels by decreasing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is the drug of choice for obese type II diabetes patients.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. Sitagliptin inhibits DPP-4, which leads to increased levels of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased levels of glucagon, and a stronger insulin response to glucose.

The committee at its 84th SEC meeting for Endocrinology & Metabolism thoroughly examined the proposal presented by pharma major Cipla.

In response to the pharma major Cipla proposal, the committee noted that the proposed FDC is approved in US and also FDC Sitagliptin 100mg/100mg plus Metformin HCl (SR) 500mg/1000 tablets and FDC of Sitagliptin ( as phosphate) 50mg plus Metformin HCl. 500mg/1000mg immediate release tablets was already approved in the country.

After detailed deliberation, the committee recommended for grant of permission for manufacture and marketing of the proposed FDC comprising Sitagliptin (50mg/50mg/100) and Metformin HCl (500mg/1000/1000mg).