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Biocon’s arm receives USFDA’s approval for Tofacitinib Extended-Release Tablets

19 Nov 2025 Evaluate

Biocon’s wholly owned subsidiary -- Biocon Pharma has received approval from the U.S Food and Drug Administration (U.S. FDA) for its ANDA for Tofacitinib Extended-Release Tablets. Final approval received for 11mg strength and tentative approval for 22mg strength. Tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitor indicated for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Ulcerative Colitis.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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