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Biocon Pharma Ltd receives approval from USFDA for its ANDA



Posted On : 2025-11-19 14:28:14( TIMEZONE : IST )

Biocon Pharma Ltd receives approval from USFDA for its ANDA

Biocon Pharma Limited, a wholly owned subsidiary of the Company, 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.

The approval will further strengthen Biocon's portfolio of vertically integrated, complex drug products.

Shares of Biocon Limited was last trading in BSE at Rs. 421.60 as compared to the previous close of Rs. 421.30. The total number of shares traded during the day was 191041 in over 4129 trades.

The stock hit an intraday high of Rs. 424.95 and intraday low of 416.25. The net turnover during the day was Rs. 80446300.00.

Source : Equity Bulls

Keywords

Biocon INE376G01013 Biotechnology BioconPharma Approval USFDA ANDA Tofacitinib ExtendedReleaseTablets