The product is bioequivalent and therapeutically equivalent to the reference listed drug Xeljanz tablets 5 mg and 10 mg of PF Prism C.V. The tablets will be manufactured at APL Healthcare unit IV, a wholly-owned subsidiary of the company, and will be launched immediately.
According to IQVIA MAT data for the twelve months ending April 2026, the tofacitinib tablets market in the US is estimated at approximately $494 million. Aurobindo Pharma now has a total of 586 ANDA approvals from the FDA, including 561 final approvals and 25 tentative approvals.
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Tofacitinib tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis, specifically in cases where patients have had an inadequate response or intolerance to prior standard therapies such as methotrexate or other disease-modifying antirheumatic drugs.
In ulcerative colitis, the use also applies to patients who have not responded adequately or are intolerant to TNF (tumour necrosis factor) blockers.
Yesterday (June 3), Aurobindo Pharma inaugurated TheraNym, a dedicated biologics contract manufacturing organisation (CMO), marking its entry into the biologics contract manufacturing segment.
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The company said the facility, located in Borapatla near Hyderabad, was inaugurated by Telangana Minister for IT, Industries & Commerce and Legislative Affairs D Sridhar Babu and Telangana Minister for Science and Technology Damodar Raja Narasimha.
The company added that TheraNym has been positioned as one of India’s largest dedicated biologics contract manufacturing facilities, with MSD (known as Merck & Co in the US and Canada) joining as its anchor customer.
Shares of Aurobindo Pharma Ltd ended at ₹1,467, up by ₹26.70, or 1.85%, on the BSE today, June 4.
(Edited by : Shoma Bhattacharjee)
