4 days ago
Gland Pharma gets USFDA approval for Cangrelor injection with 180-day exclusivity
Gland Pharma Limited, a leading player in the generic injectable and ophthalmic pharmaceutical space, has received the green light from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cangrelor for Injection, 50 mg/vial.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug KENGREAL, developed by Chiesi USA Inc. Cangrelor Injection is prescribed as an adjunct to percutaneous coronary intervention (PCI) to lower the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not received a P2Y12 platelet inhibitor and are not being administered a glycoprotein IIb/IIIa inhibitor.
One major highlight of this approval is that Gland Pharma will enjoy 180 days of generic drug exclusivity in the U.S. market — a key competitive advantage that could boost its revenue in the near term.
According to IQVIA data, Cangrelor Injection recorded approximately USD 122 million in U.S. sales in the 12 months ending June 2025, highlighting the strong market potential for Gland Pharma's launch.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
