Gland Pharma bags USFDA nod for Cangrelor for Injection
Hyderabad: Gland Pharma Limited, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the company 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 (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 llb/llla inhibitor.
Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
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