Concord Biotech Limited has announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tofacitinib Tablets in 5 mg and 10 mg strengths.
The approval is expected to strengthen the company's presence in the U.S. pharmaceutical market and support its long-term growth strategy.
According to the company, the USFDA has approved its ANDA for Tofacitinib Tablets, 5 mg and 10 mg.
The drug is indicated for the treatment of several autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis.
Concord Biotech stated that the combined U.S. market for both strengths of Tofacitinib Tablets is estimated at approximately $500 million.
The approval allows the company to participate in this market opportunity while expanding its portfolio of products in the United States.
The company said the approval is in line with its growth strategy and is expected to strengthen its position in the U.S. market.
The development is also expected to enhance Concord Biotech's product offerings and support its expansion across international markets.
The approval adds another product to Concord Biotech's regulated market portfolio and highlights the company's focus on expanding its presence in key global markets.
The company continues to pursue regulatory approvals aimed at increasing its footprint in the U.S. generics market.
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As of 10 June 2026, at 10:50 AM, Concord Biotech share price is trading at ₹1,328.50 per share, reflecting a surge of 4.43% from the previous closing price.
The USFDA approval for Tofacitinib Tablets marks a significant milestone for Concord Biotech. With access to a market estimated at around $500 million, the approval is expected to support the company's growth ambitions and strengthen its presence in the U.S. pharmaceutical market.
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Published on: Jun 10, 2026, 11:57 AM IST
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