Granules India Business Update
Granules India filed a Paragraph IV ANDA certification for Ruxolitinib ER Tablets, claiming potential 180-day U.S. generic exclusivity, subject to FDA review and confirmation.
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Granules India filed a Paragraph IV ANDA certification for Ruxolitinib ER Tablets, claiming potential 180-day U.S. generic exclusivity, subject to FDA review and confirmation.
Granules India Ltd submitted a Monitoring Agency report for the quarter ended June 30, 2026. The report tracks proceeds from a Preferential Issue.
Granules India Limited released its Business Responsibility & Sustainability Report for FY 2025-26. The report highlights achievements in ESG, climate action, and workplace safety certifications.
Granules India's US subsidiary received a USFDA EIR with VAI classification for its Chantilly facility. The report concludes a March 2026 inspection involving four observations.
Granules India's US subsidiary, GPI, completed a routine US FDA cGMP audit at its Chantilly, Virginia site with four procedural observations. The inspection, conducted from March 30 to April 3, 2026, reported no data integrity issues. The company committed to addressing the observations within stipulated timelines to maintain regulatory compliance.