CDSCO nod to Synokem Pharma for marketing, manufacturing antidiabetic FDC Pioglitazone, Vildagliptin

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.

For more details, check out the link given below:

Synokem Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Pioglitazone, Vildagliptin