Summary –
Gland Pharma Limited has recently received a tentative approval from the United States Food and Drug Administration (USFDA) for Cangrelor for Injection, 50 mg/vial Single-Dose Vials.
“Gland Pharma believes that we are amongst one of the first to files for this product and may be eligible for 180 days of generic drug exclusivity,” the company said in a release.
Gland Pharma will launch the product with its marketing partner on receipt of final approval.
USFDA Nod for Gland Pharma Injectable
Gland Pharma, a generic injectable focused pharmaceutical company was established in 1978 in Hyderabad.
It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology and ophthalmic solutions.
Cangrelor is used during percutaneous coronary intervention (PCI) for reducing the risk of heart attacks, repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with another P2Y12 platelet inhibitor.
Gland Pharma believes that it is amongst one of the first to file for the product and may be eligible for 180 days of generic drug exclusivity. The drug company will launch the product with its marketing partner on receipt of final approval.
Hyderabad-based Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets.
The injectables manufacturer’s consolidated net profit rose 38% to Rs 302.1 crore in Q2 FY22 from Rs 218.9 crore in Q2 FY21. Revenue from operations increased by 30% YoY to Rs 1,080.5 crore during the quarter.
Cangrelor for Injection
Cangrelor for Injection is a sterile white to off-white lyophilized powder for IV infusion. In addition to the active ingredient, cangrelor, each single use vial contains mannitol, sorbitol, and sodium hydroxide to adjust the pH.