Concord Biotech Share Price Surges Up to 5.96% After USFDA Approves Tofacitinib Tablets ANDA in 5 mg and 10 mg Strengths
- June 10, 2026
- Posted by: Ankit Jaiswal
- Category: Market
Concord Biotech share price: CMP Rs 1,340 (+5.33%) on June 10, 2026. Open Rs 1,284, High Rs 1,349.90, Low Rs 1,282.60, Prev close Rs 1,272.20. USFDA ANDA approval for Tofacitinib Tablets 5mg and 10mg. US market: ~$500 million. 52W high Rs 2,150.40 (Jun 11, 2025); 52W low Rs 987 (Apr 2, 2026). MCap Rs 13,848 crore.
The Concord Biotech share price surged up to 5.33% to Rs 1,340, hitting an intraday high of Rs 1,349.90 on Wednesday, June 10, 2026, after the Ahmedabad-based biopharmaceutical company announced receipt of US Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Tofacitinib Tablets in 5 mg and 10 mg strengths. The approval was disclosed through a stock exchange filing under SEBI Regulation 30. The combined US market for Tofacitinib Tablets across both strengths is estimated at approximately US$500 million, opening a significant revenue opportunity for the Concord Biotech share price and its US generics business. This marks the company’s second major USFDA ANDA approval within a week, following the Mycophenolate Mofetil approval on June 3, 2026.
Click Here – Get Free Stock Research From Univest
USFDA Tofacitinib Approval: Key Details
| Detail | Information |
|---|---|
| Type of Approval | USFDA Abbreviated New Drug Application (ANDA) — Final Approval |
| Drug | Tofacitinib Tablets |
| Strengths Approved | 5 mg and 10 mg |
| US Market Size (both strengths) | ~US$500 million (source: IQVIA estimates) |
| Indications | Rheumatoid arthritis (RA), Psoriatic arthritis, Ankylosing spondylitis, Ulcerative colitis, Juvenile idiopathic arthritis |
| Regulatory Filing | SEBI Regulation 30 disclosure, June 10, 2026 |
| Branded Reference Drug | Xeljanz (Pfizer) — patent expiry opens generic opportunity |
| Previous USFDA Approvals (FY26) | Mycophenolate Mofetil (June 3, 2026), Teriflunomide Tablets (April 2025) |
Research Pharma Stocks and Concord Biotech With Univest
Univest covers Concord Biotech and all pharma stocks with live prices, USFDA tracker, and analyst research.
- Live Concord Biotech share price tracking and USFDA approval alerts
- Pharma sector analysis with ANDA pipeline and US market opportunity data
- Daily stock picks with expert research from Univest analysts
Unlock the latest Top Stock Picks on Univest
Concord Biotech Share Price: Current Snapshot
| Parameter | Details |
|---|---|
| NSE Symbol | CONCORDBIO |
| Sector | Pharmaceuticals / Biopharma |
| CMP (Jun 10, intraday high) | Rs 1,340 (+5.33%) |
| At 10:51 AM | Rs 1,349.90 (day high) |
| Previous Close | Rs 1,272.20 |
| Day High | Rs 1,349.90 |
| 52-Week High | Rs 2,150.40 (June 11, 2025) |
| 52-Week Low | Rs 987 (April 2, 2026) |
| YTD Performance | -1% |
| 1-Month Return | +13% |
| 1-Week Return | +10% |
| Market Capitalisation | Rs 13,848.05 crore |
| Business | R&D-driven biopharma: APIs (fermentation) + finished formulations |
Why Tofacitinib is a Significant Opportunity
The Concord Biotech share price rally reflects the market’s recognition of the Tofacitinib opportunity. Tofacitinib is a JAK (Janus Kinase) inhibitor that has become a significant drug class in treating autoimmune conditions. The branded version, Xeljanz (Pfizer), generated peak annual US revenues exceeding $1 billion before patent expiry. With the combined 5 mg and 10 mg US market estimated at $500 million, and with Concord now holding a final ANDA approval, the company can file for a supply authorisation and begin commercial launch in the US once it clears any remaining regulatory steps. This direct-to-market access in regulated pharmacy channels is a meaningful step forward for the Concord Biotech share price‘s revenue trajectory.
Recent USFDA Approval Track Record
The Concord Biotech share price has been building strong momentum from a series of USFDA approvals in FY26. On June 3, 2026, the company received USFDA approval for Mycophenolate Mofetil for Oral Suspension USP (200 mg/ml), targeting the US$30 million oral suspension market, and the stock had surged 8% on that day. Prior to that, in April 2025, the company received approval for Teriflunomide Tablets (7 mg and 14 mg), targeting a ~$402 million US market. Each approval adds a new revenue stream to the US business, compounding the growth potential visible in the Concord Biotech share price.
Technical Position: 37% Below 52-Week High
Despite today’s strong surge, the Concord Biotech share price at Rs 1,327-1,348 remains approximately 37-40% below its 52-week high of Rs 2,150.40 (hit on June 11, 2025). The stock hit a 52-week low of Rs 987 on April 2, 2026, before recovering on successive USFDA approval catalysts. The recovery from Rs 987 to Rs 1,348 represents a 36.6% gain from the low, supported by the company’s strong regulatory execution. For the Concord Biotech share price to fully recover, sustained US launch momentum and revenue contribution from the newly approved products will be key.
Screen Concord Biotech and Top Pharma Stocks Live on the Univest Screener
Conclusion
The Concord Biotech share price surge of up to 5.96% (intraday high Rs 1,349.90, current Rs 1,336.20) today is directly attributed to the USFDA ANDA approval for Tofacitinib Tablets in 5 mg and 10 mg, addressing a ~$500 million US market. Combined with the Mycophenolate Mofetil approval a week ago, Concord Biotech is building a robust US generics pipeline that could drive sustained re-rating in the Concord Biotech share price over the next 12-24 months. Track live prices and USFDA approval news on Univest.
Download the Univest iOS App or Univest Android App to track Concord Biotech share price live with pharma research and USFDA alerts on Univest.
Disclaimer: Data sourced from NSE/BSE/public filings. This content is for educational purposes only and is not investment advice by Univest (SEBI RA INH000013776). Investments are subject to market risk. Consult a SEBI-registered financial advisor before investing.
Frequently Asked Questions
Why is Concord Biotech share price rising today?
Ans. Concord Biotech share price is rising up to 5.96% today after the company announced receipt of USFDA final approval for its Abbreviated New Drug Application (ANDA) for Tofacitinib Tablets in 5 mg and 10 mg strengths. This approval opens a US$500 million market opportunity for the company. Tofacitinib is a JAK inhibitor used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The USFDA nod positions Concord Biotech to compete in the generic Tofacitinib market in the US, which is the world’s largest generics market.
What is Tofacitinib and why is the USFDA approval significant?
Ans. Tofacitinib is a Janus Kinase (JAK) inhibitor used to treat moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. The branded version is Xeljanz by Pfizer, which had annual US revenues exceeding $1 billion at peak. The combined US market for both 5 mg and 10 mg Tofacitinib Tablets is estimated at approximately US$500 million. Concord Biotech receiving USFDA ANDA approval allows it to market a generic version, capturing a share of this significant market.
What is the Concord Biotech share price outlook after the USFDA approval?
Ans. The Concord Biotech share price at ~Rs 1,340 today is still approximately 37.7% below its 52-week high of Rs 2,150.40 (June 11, 2025), suggesting potential recovery room if the US generics launch gains traction. The company has been building a strong USFDA approval track record in FY26 with multiple ANDA clearances including Mycophenolate Mofetil and now Tofacitinib. Each approved product expands the US revenue pipeline. The 1-month return of +13% and 1-week return of +10% suggest the stock is in a positive momentum phase.
What does Concord Biotech do as a company?
Ans. Concord Biotech Limited, founded in 2000, is an R&D-driven biopharmaceutical company headquartered in Ahmedabad. The company specialises in the production of Active Pharmaceutical Ingredients (APIs) through fermentation and semi-synthetic processes, along with finished formulations. Its API portfolio includes immunosuppressants, oncology, and anti-infective categories. The US generics market is a key growth vector, and the company has been progressively building its ANDA pipeline to capitalise on patent expiry opportunities. Concord Biotech incorporated a marketing subsidiary Concord Lifegen for US commercial activities.
