Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Cangrelor for Injection 50mg/vial. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA Inc.
This Product is indicated for an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. Gland Pharma is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of around $122 million for the twelve months ending June 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
