Zydus Cadila gets tentative nod for Sitagliptin, Metformin Hydrochloride Tablets

14 Mar 2019 Evaluate

Zydus Cadila has received the tentative approval from the US Food and Drug Administration (USFDA) to market Sitagliptin and Metformin Hydrochloride Extended-Release Tablets, (US RLD-JANUMET XR), 50 mg/500 mg, 50 mg/ 1,000 mg and 100 mg/ 1,000 mg.

It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. It contains two oral antidiabetic medications used in the management of type 2 diabetes -Sitagliptin and metformin hydrochloride extended-release.

The group now has 255 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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