Concord Biotech Secures USFDA Approval for Tofacitinib Tablets; Shares Jump 5.96%

Mumbai, June 10: Concord Biotech Limited said 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 company disclosed the development through an exchange filing under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

According to the filing, Tofacitinib Tablets are indicated for treatment of patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and juvenile idiopathic arthritis across specified patient categories.

Concord Biotech said the approval strengthens its product portfolio in the U.S. market and aligns with its broader strategy of expanding its regulated market presence.

The company also cited market estimates indicating that the combined U.S. market opportunity for both strengths of Tofacitinib Tablets stands at around US$500 million.

Stock Market Snapshot

Concord Biotech share price rallied sharply after the company announced the USFDA approval.

The stock was trading at ₹1,348.00, up 5.96%, as of 11:50 IST on June 10, 2026, according to market data.

The strong move reflected investor optimism around the company’s growing U.S. generics pipeline and its ability to expand in regulated pharmaceutical markets.

Concord Biotech share price has remained in focus in recent sessions amid continued interest in export-oriented pharmaceutical companies receiving regulatory clearances from global health authorities.

Approval Strengthens U.S. Market Position

The company stated that the approval is expected to support long-term growth opportunities in the U.S. and international pharmaceutical markets.

According to the filing, the approval pertains specifically to Tofacitinib Tablets in 5 mg and 10 mg dosages under the ANDA pathway.

The USFDA approval also enhances Concord Biotech’s ability to strengthen its offerings in immunology and inflammation-related therapeutic categories, where demand for generic treatment alternatives continues to rise.

Focus Remains On Regulated Market Expansion

Concord Biotech operates in the pharmaceutical and biotechnology segment with a focus on active pharmaceutical ingredients and finished dosage formulations.

The latest approval reflects the company’s continued focus on expanding its regulated market footprint through product filings, approvals and portfolio diversification.

The company said the approval remains valid and there has been no withdrawal, cancellation or suspension associated with the regulatory clearance.

Source:

• https://www.nseindia.com/get-quote/equity/CONCORDBIO/Concord-Biotech-Limited
• https://nsearchives.nseindia.com/corporate/CONCORD_10062026101245_Intimation_ANDA.pdf