Synokem Gets CDSCO Panel Nod To Manufacture, Market antidiabetic FDC Pioglitazone, Vildagliptin
New Delhi: With the condition of conducting phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to the drug major Synokem Pharmaceutical for manufacturing and marketing the antidiabetic fixed-dose combination (FDC) drug Pioglitazone plus Vildagliptin film coated bilayered tablet.
This came after Synokem Pharmaceutical presented the clinical trial report of Pioglitazone plus Vildagliptin (30mg/100mg +15mg/100mg) film-coated bilayered tablet, before the committee. The committee noted that the firm has already presented a bioequivalence (BE) study report in the SEC meeting held on 09.09.2022.
Vildagliptin is used to control blood sugar levels in patients with type 2 diabetes mellitus. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Vildagliptin is an antidiabetic medication.
Vildagliptin binds covalently to the catalytic site of DPP-4, eliciting prolonged enzyme inhibition. This raises intact GLP-1 levels, both after meal ingestion and in the fasting state. Vildagliptin has been shown to stimulate insulin secretion and inhibit glucagon secretion in a glucose-dependent manner.
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