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Zydus Cadila receives tentative approval from USFDA for Deferasirox Tablets

Zydus Cadila has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Deferasirox Tablets, 90 mg, 180 mg, and 360 mg (US RLD – Exjade Tablets). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad in the state of Gujarat.

It is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia).

The group now has 231 approvals and has so far filed over 340 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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