Aurobindo Pharma shares rose 1.80% to ₹1,489.95 following the announcement of USFDA approval for Tofacitinib tablets, as reported by Business Standard. The stock movement reflects positive market sentiment toward the company's expanded US generic portfolio. The company's market capitalisation stands at ₹85,006.13 crore, with the regulatory approval removing a key development risk for investors.
According to reports from Moneycontrol, Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Tofacitinib tablets, 5 mg and 10 mg, the generic version of PF Prism C.V.'s Xeljanz Tablets. The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Xeljanz Tablets, marketed by Pfizer. The product is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis (UC). As per Business Standard, the drug will be manufactured at APL Healthcare Unit IV, a wholly owned subsidiary of Aurobindo Pharma, with the unit being one of India's largest dedicated biologics contract manufacturing organisations (CMOs).
As reported by Innovacia Insights, the company plans an immediate commercial launch in the US market, targeting a market estimated at approximately US$494 million. According to IQVIA MAT data for the 12 months ended April 2026, the US market for Tofacitinib tablets is estimated at approximately $494 million. This approval represents a significant expansion of the company's US generic portfolio in the immunology and gastroenterology therapeutic areas. The drug will be launched immediately following the regulatory approval.
According to Business Standard, the company on June 3 inaugurated TheraNym, one of India's largest dedicated biologics contract manufacturing organisations (CMOs). Located at Borapatla near Hyderabad, the facility is positioned as one of India's largest dedicated biologics CMOs. Aurobindo Pharma confirmed that 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. This development positions the company to expand its capabilities beyond small molecule generics into the growing biologics market, enhancing its presence in the specialty and complex generics segment.
As reported by Business Standard, Aurobindo Pharma reported a 2% rise in consolidated net profit to ₹921.26 crore on a 4.4% increase in net sales to ₹8,751.50 crore in Q4 FY26 over Q4 FY25. Following this approval, Aurobindo Pharma has a total of 586 ANDA approvals from the USFDA, comprising 561 final approvals and 25 tentative approvals. The company is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services.
