Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

By: IPP Bureau

Last updated : August 12, 2025 9:09 pm



The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA


Gland Pharma Limited, a generic injectable & ophthalmicfocused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Cangrelorfor 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 (Ml), 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 approximately US$122 million for the twelve months ending June 2025.

Gland Pharma Limited United States Food and Drug Administration USFDA KENGREAL Chiesi USA

First Published : August 12, 2025 12:00 am