Zydus Receives Tentative Approval for Sitagliptin and Metformin Hydrochloride Extended-Release Tablets

Zydus Cadila has received the tentative approval from the US FDA to market Sitagliptin and Metformin Hydrochloride Extended-Release Tablets, (US RLD – JANUMET XR), 50 mg/500 mg, 50 mg/1000 mg and 100 mg/1000 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. – Medical Buyer Bureau

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