15 March 2019 | News
Zydus receives tentative approval from the USFDA for Sitagliptin and Metformin Hydrochloride Extended-Release tablets
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies
The company has received the tentative approval from the 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.