India Pharma Outlook Team | Tuesday, 12 August 2025
Gland Pharma Limited, a generic injectable and ophthalmic company, has reported receiving a United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Cangrelor for Injection 50mg/vial.
The approved drug has the same formulation as therapeutically comparable reference-labeled drug KENGREAL, manufactured by Chiesi USA Inc. The drug is used as an adjunct to percutaneous coronary intervention (PCI) for the minimization of 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 on a glycoprotein IIb/IIIa inhibitor.
Upon approval, Gland Pharma will have 180 days of exclusivity for the US market generic drug. As per IQVIA sales data, Cangrelor for Injection had around USD 122 million of US sales up to June 2025.
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Established in 1978, Gland Pharma evolved from its original contract manufacturing status as a small-volume liquid parenteral to a prominent, fastest-growing injectable-focused business with international reach across more than 60 countries in the United States, Europe, Canada, Australia, and India. Working primarily in a business-to-business (B2B) model, the company formulates, manufactures, and markets a broad array of sterile injectables.
It has ampoules, vials, pre-filled syringes, lyophilized vials, dry powders, oncology pharmaceuticals, ophthalmic drops, and infusions in its domestic and global healthcare market products.
This further approval also makes Gland Pharma's U.S. offerings larger and enhances its global injectable presence.
