Aurobindo Pharma Secures Final US FDA Approval for Tofacitinib Tablets, 5 mg and 10 mg

Aurobindo Pharma Secures Final US FDA Approval for Tofacitinib Tablets, 5 mg and 10 mg​

Aurobindo Pharma Limited has obtained final approval from the U.S. Food & Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets, available in 5 mg and 10 mg strengths. The tablets are noted as being bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz Tablets, 5 mg and 10 mg of PF Prism C.V.

The product will be launched immediately and manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of the company.

According to IQVIA MAT data for the twelve months ending April 2026, the estimated market size of Tofacitinib Tablets, 5 mg and 10 mg in the U.S. is approximately US$ 494 million. This approval adds to Aurobindo Pharma’s growing portfolio, which currently holds a total of 586 ANDA approvals from USFDA, including 561 final approvals and 25 tentative approvals.

Tofacitinib Tablets have specific indications for the treatment of various conditions:

• Adult patients with moderately to severely active rheumatoid arthritis who experienced an inadequate response or intolerance to methotrexate.
• Adult patients with active psoriatic arthritis who experienced an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
• Adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or are intolerant to TNF blockers.

Global Pharmaceutical Presence​

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients across more than 150 countries.

With over 30 manufacturing and packaging facilities, the company holds approvals from key regulatory bodies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. Aurobindo Pharma’s product portfolio spans seven major therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and AntiAllergic.

AUROPHARMA Stock Price Movement​

Today, Aurobindo Pharma Limited shares edged higher to close at ₹1463.6, after gaining 1.74%. The stock saw substantial activity in the market, with a total traded volume of 931,335 shares.