Company Disclosure

Granules India Limited (Scrip Code: NSE: GRANULES; BSE: 532482) submitted a regulatory filing dated October 07, 2026, regarding its ANDA submission for Ruxolitinib Extended-Release Tablets.

Key Development Details

  • The company has submitted a Paragraph IV certification in connection with its ANDA for Ruxolitinib Extended-Release Tablets
  • The certification pertains to applicable patents listed in the FDA's Orange Book
  • Required notice has been provided to relevant parties in accordance with US regulatory requirements

Potential Regulatory Status

  • Based on the timing and status of its ANDA and Paragraph IV certification, Granules believes it is eligible for first-to-file status
  • Subject to FDA review and determination, first-to-file status may provide eligibility for 180 days of generic drug exclusivity under US law
  • The ANDA remains subject to FDA review, and this announcement does not constitute FDA approval or confirmation of first-to-file status

Management Commentary

Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, stated that first-to-file opportunities are an important part of the company's strategy to build a more differentiated and higher-value product portfolio in the US. The filing reflects the company's focus on identifying technically and commercially attractive opportunities where development and manufacturing capabilities can create sustainable value.

Forward-Looking Statements

The communication contains forward-looking statements relating to the company's ANDA, potential first-to-file status, possible eligibility for 180-day exclusivity, regulatory review, and commercialization prospects. These statements are subject to risks and uncertainties including FDA actions, patent litigation, exclusivity determinations, competition, and other factors.

Company Background

Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company has 10 manufacturing facilities (7 in India, 2 in US, 1 in Switzerland) and products distributed to over 300 customers across 80+ countries.