The Paragraph IV certification sought is with respect to applicable patents listed in the U.S. FDA’s Orange Book. Granules said it has also issued the requisite notice to the relevant parties in accordance with U.S. regulatory requirements.
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October 7, 2026 at 10:27 AM
Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.
The Hindu Business
Excerpt from The Hindu Business.