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Gland Pharma receives approval from USFDA for Cangrelor for Injection 50 mg/vial

Posted On: 2025-08-12 17:56:42 (Time Zone: IST)


Gland Pharma Limited (Gland or Company), 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 USAInc.

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 USsalesof approximately USD122 million for the twelve months ending June 2025.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1936.40 as compared to the previous close of Rs. 1933.00. The total number of shares traded during the day was 3611 in over 392 trades.

The stock hit an intraday high of Rs. 1944.40 and intraday low of 1908.25. The net turnover during the day was Rs. 6960970.00.


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