Zydus Cadila receives USFDA’s approval for Tofacitinib Tablets

06 Apr 2019 Evaluate

Zydus Cadila has received the tentative approval from the United States Food & Drug Administration (USFDA) to market Tofacitinib Tablets (US RLD — Xeljanz Tablets), 5 mg.

Tofacitinib is used alone or with other medications (such as methotrexate) to treat moderate to severe forms of rheumatoid arthritis. It helps to decrease pain, tenderness and swelling in the joints. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad in the state of Gujarat. The group now has 260 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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