Aurobindo Pharma gains after receiving USFDA approval for Tofacitinib tablets

Aurobindo Pharma rose 1.80% to Rs 1,489.95 after the company announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Tofacitinib Tablets in 5 mg and 10 mg strengths.

The product is bioequivalent and therapeutically equivalent to the reference listed drug, Xeljanz Tablets, of PF Prism C.V. It will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of the company, and is scheduled for immediate launch.

According to IQVIA MAT data for the 12 months ended April 2026, the US market for Tofacitinib tablets is estimated at approximately $494 million. Following this approval, Aurobindo Pharma has a total of 586 ANDA approvals from the USFDA, comprising 561 final approvals and 25 tentative approvals.

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.

Separately, the company inaugurated TheraNym, its dedicated biologics contract manufacturing organization (CMO), marking its entry into the biologics contract manufacturing segment. Located at Borapatla near Hyderabad, the facility is positioned as one of India's largest dedicated biologics CMOs.

Aurobindo Pharma said MSD (known as Merck & Co. in the US and Canada) will serve as the anchor customer for the facility, which has been established to support domestic and export supply requirements, subject to applicable approvals and customer requirements.

Aurobindo Pharma is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services. The company reported a 2% rise in consolidated net profit to Rs 921.26 crore on a 4.4% increase in net sales to Rs 8,751.50 crore in Q4 FY26 over Q4 FY25.

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