Gland Pharma Limited has informed the Exchange regarding a press release dated August 12, 2025, titled "Gland Pharma receives approval from the United States Foodand Drug Administration (USFDA) for Cangrelor for Injection".
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Gland Pharma has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Cangrelor for Injection 50mg/vial, a generic version of KENGREAL marketed by Chiesi USA. The product is used as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of heart attacks, repeat coronary revascularization, and stent thrombosis. Gland Pharma qualifies for 180 days of generic drug exclusivity in the US market. According to IQVIA, the reference product had US sales of approximately USD 122 million for the twelve months ending June 2025, indicating a meaningful market opportunity. Gland Pharma operates primarily as a B2B injectable-focused pharmaceutical company with a presence in 60 countries.
This is a positive development for shareholders as it expands Gland Pharma's US product portfolio with a high-value injectable and grants 180-day exclusivity, which could translate into significant early-mover revenue. The approval could support growth in the company's US generics business, though pricing pressure typically follows exclusivity expiry.