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.
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