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Zydus Cadila gets tentative approval from USFDA for Empagliflozin and Metformin Hydrochloride Tablets

Pharmaceutical major Zydus Cadila today said it 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 (US RLD: SynjardyTM Tablets).

In a regulatory filing, the drug manufacturer said, “a combination of 2 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,” it added. 

Last month, Zydus Cadila received tentative nod from the US health regulator to market generic Empagliflozin tablets in the strength of 25 mg. 

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.

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