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3 min read | Updated on June 04, 2026, 18:42 IST
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With this approval, Aurobindo Pharma now has a total of 586 ANDA approvals (561 final approvals and 25 tentative approvals) from the USFDA
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From the beginning of the year, shares of Aurobindo Pharma have soared 23%. Image: Shutterstock
Aurobindo Pharma on Thursday, June 6, said that it has received a final approval from the US Food & Drug Administration (USFDA) to manufacture a drug for arthritis.
The drugmaker, in a regulatory filing, said it got the nod to manufacture and market Tofacitinib Tablets, 5 mg and 10 mg, which are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz Tablets, 5 mg and 10 mg, of PF Prism C.V.
Aurobindo Pharma stated that Tofacitinib tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, as well as for adult patients with active psoriatic arthritis who have shown an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
The company added that the tablets are also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or are intolerant to TNF blockers.
The product 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, Tofacitinib Tablets, 5 mg and 10 mg, have an estimated market size of approximately $494 million in the US.
With this approval, Aurobindo Pharma now has a total of 586 ANDA approvals (561 final approvals and 25 tentative approvals) from the USFDA.
For Q4 FY26, the pharma company had reported a 2% rise in consolidated profit after tax to ₹920.84 crore. It had posted a consolidated profit after tax (PAT) of ₹902.83 crore in the corresponding quarter of the previous fiscal.
Its consolidated total revenue from operations in the fourth quarter stood at ₹8,853.34 crore against ₹8,382.12 crore in the year-ago period.
Aurobindo Pharma's total expenses during the quarter were higher at ₹7,677.34 crore compared to ₹7,149.65 crore in the year-ago period.
For FY26, consolidated PAT was ₹3,502.97 crore against ₹3,483.57 crore in FY25. Its consolidated total revenue from operations in FY26 stood at ₹33,653.08 crore against ₹31,723.73 crore in FY25.
On Thursday, Aurobindo Pharma shares closed at ₹1,463.6 apiece on the National Stock Exchange, rising 1.61%.
Shares of the firm have jumped 6.5% over a month, while they have surged 20% in the past six months. From the beginning of the year, shares of Aurobindo Pharma have soared 23%.
The company has a market capitalization of ₹84,321.63 crore.
Shares of the company had touched their one-year high of ₹1,550 apiece on May 21, 2026, while their 52-week low of ₹1,016.10 was hit on September 1, 2025.
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