Biocon‍‌‍‍‌‍‌‍‍‌ Pharma US FDA Approved for Tofacitinib Extended-Release Tablets; Stock in the Spotlight Today

Mumbai, 19 November 2025: BIOCON Limited (NSE: BIOCON, BSE: 532523) announced on Tuesday that its wholly-owned subsidiary, Biocon Pharma Limited, has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Tofacitinib Extended-Release Tablets. The company has been granted full approval for the 11 mg strength and tentative approval for the 22 mg strength, marking a key milestone in expanding its complex generics portfolio.

Points of Focus for the Approval

Biocon Pharma received the go-ahead for the production of Tofacitinib Extended-Release Tablets, a Janus kinase (JAK) inhibitor used for the treatment of multiple autoimmune and inflammatory diseases such as Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis. The firm informed that this regulatory milestone opens new avenues for Biocon Pharma in the US generics market, especially in the highly complex, vertically integrated drug products segment of high-value.

Strategic Importance

This is a big win for Biocon as they get to keep their competitive edge in the immunology therapeutics space with the FDA approval of the drug. Besides, the company’s bigger pipeline of specialty and complex formulations will be further strengthened with the presence of Tofacitinib ER. This will back up the company’s long-term plan of increasing worldwide pharmaceutical offerings.

Stock Market Performance

The market, however, remained apprehensive, which was evident in its stock performance. The share price of Biocon Pharma was down by 2.75% trading at ₹410.00 as of 2:14 pm IST.

REF: https://nsearchives.nseindia.com/corporate/Biocon2_19112025090703_SE_notification_Tofacitinib_approval-US_Final_181125_SIGNED.pdf

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