Zydus gets tentative USFDA approval for empagliflozin and metformin hydrochloride tablets

It will be manufactured at the group’s formulations manufacturing facility at SEZ in Ahmedabad

Zydus Cadila has received tentative approval from the USFDA to market empagliflozin and metformin hydrochloride tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg.

A combination of two drugs: empagliflozin and metformin, this medication is used with a proper diet and exercise programme to control high blood sugar in people with type 2 diabetes. It will be manufactured at the group’s formulations manufacturing facility at SEZ in Ahmedabad. The group now has 289 approvals and has so far filed over 386 ANDAs since the commencement of the filing process in FY 2003-04.

ANDAempagliflozinmetformin hydrochloride tabletsUS FDA approvalZydus Cadila
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