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The inspection took place from 18 June 2026 to 24 June 2026.
The successful completion of PPB and NDA inspection marks a significant milestone in Concord Biotech’s global growth journey.
“This achievement reinforces our commitment to the highest standards of quality and regulatory excellence while strengthening our global manufacturing and regulatory footprint,” the company said in a statement.
Concord Biotech is an R&D-driven biopharma company that manufactures Active Pharmaceutical Ingredients (APIs) through fermentation & semi-synthetic processes and finished formulations. It has a presence in more than 70 countries worldwide.
The company’s consolidated net profit declined 36.75% to Rs 88.79 crore on a 24.15% drop in revenue from operations to Rs 326.07 crore in Q4 FY26 over Q4 FY25.
The scrip rose 0.63% to currently trade at Rs 1296.80 on the BSE.
The company said, 'The successful completion of the ANVISA inspection marks a significant milestone in Concord Biotech's global growth journey. This achievement reinforces our commitment to the highest standards of quality and regulatory excellence while strengthening our global manufacturing and regulatory footprint. It also advances our international expansion strategy by enhancing access to one of the world's largest pharmaceutical markets and broadening the reach of our high-quality APIs across key geographies.'
The counter rose 0.30% to Rs 1,349.30 on the BSE.
According to market estimates, the US market size for Tofacitinib tablets across both strengths is approximately $500 million. The approval is expected to enable the company to tap this market opportunity, expand its product portfolio, and support its long-term growth strategy in the US and other international markets.
Concord Biotech has received approval from the U.S. Food and Drug Administration (USFDA) for its ANDA for Tofacitinib Tablets, 5 mg and 10 mg. Tofacitinib tablets are indicated for the treatment of adult patients with Moderately to severely active rheumatoid arthritis (RA), Active psoriatic arthritis (PsA), Active ankylosing spondylitis (AS), Moderately to severely active ulcerative colitis (UC), Active PsA, Active polyarticular course juvenile idiopathic arthritis (pcJIA).
According to market estimates, the U.S. market for Tofacitinib Tablets both strengths put together is approximately US$ 500 million. The approval positions the Company to capitalize on these attractive market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets.
According to market estimates, the U.S. market for Mycophenolate Mofetil is approximately US$ 30 million. The approval positions the company to capitalize on these attractive market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets.
Concord Biotech is a R&D driven biopharma company that manufactures Active Pharmaceutical Ingredients (API) through fermentation & semi-synthetic process and finished formulations. It has a presence in more than 70 countries worldwide.
The company’s consolidated net profit declined 36.75% to Rs 88.79 crore on 24.15% drop in revenue frm operations to Rs 326.07 crore in Q4 FY26 over Q4 FY25