Zydus Cadila gets tentative approval from USFDA for Sitagliptin Tablets

11 Sep 2018 Evaluate

Zydus Cadila has received the tentative approval from the US Food and Drug Administration (USFDA) for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg (US RLD-Januvia Tablets). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).

The group now has 217 approvals and has so far filed over 330 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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