Zydus receives US FDA approval for Glyburide and Metformin Hcl tabs

The formulations manufacturing facility at Baddi will produce the drug for the US market

Zydus Cadila has received the final approval from the US FDA to market Glyburide and Metformin Hcl tablets USP in strengths of 1.25/250, 2.5/500 and 5/500 mg. The drug falls in the anti-diabetics segment and the group’s formulations manufacturing site at Baddi will be producing the drug for the US market.

The group now has 103 approvals and has so far filed over 280 ANDAs since the commencement of the filing process in FY 2003-04.