Serdia Pharma gets CDSCO nod for anti-diabetic FDC of extended-release Gliclazide 60mg plus Metformin 1000mg tablet

New Delhi: In a significant development, Serdia® Pharmaceuticals (India) Pvt. Ltd. has got approval from the  Central Drugs Standard Control Organization (CDSCO) to manufacture and market an anti-diabetic fixed-dose combination uncoated bilayer tablet comprising Gliclazide 60mg (as extended-release) plus Metformin Hydrochloride IP 1000mg (as extended-release) tablet.

Gliclazide plus Metformin is a combination of two antidiabetic medicines, used in the treatment of type 2 diabetes mellitus (T2DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.

Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). Gliclazide is a sulfonylurea that acts by increasing the amount of insulin released by the pancreas in order to lower blood glucose.

Gliclazide binds to the pancreatic β cell Sulfonylurea receptor (SUR1). This binding subsequently blocks the ATP-sensitive potassium channels which open voltage-dependent calcium channels in the β cell leading to exocytosis of insulin-containing secretory granules.

Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type 2 diabetes mellitus  (T2DM). Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.

The CDSCO granted permission for the manufacturing and marketing of a fixed-dose combination uncoated bilayer tablet comprising Gliclazide IP 60mg (as extended-release) plus Metformin Hydrochloride IP 1000mg (as extended-release) after the firm submitted a BA/BE study report.

Serdia® Pharmaceuticals (India) Pvt. Ltd has made available the said drug in the market under the brand DIAMICRON® XR MEX 60/1000. (For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.)