Gland Pharma Limited has informed the Exchange regarding a press release dated August 12, 2025, titled "Gland Pharma Receives Approval for Norepinephrine Bitartrate in 5% DextroseInjection Bags".
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Awaiting price reaction for this filing.
Gland Pharma has received USFDA approval for Norepinephrine Bitartrate in 5% Dextrose Injection in two strengths: 4 mg/250 mL and 8 mg/250 mL single-dose bags. The product is used to raise blood pressure in adult patients with severe, acute hypotension and is the generic equivalent of Baxter Healthcare's reference drug. Gland Pharma is the exclusive First-to-File applicant, making it eligible for 180 days of generic drug exclusivity in the US market. According to IQVIA, the US market for this product was approximately USD 55 million in the 12 months ending June 2025.
Positive for shareholders. The 180-day exclusivity gives Gland Pharma a six-month monopoly in a ~$55 million US market, which could meaningfully boost near-term US revenue and margins. As a First-to-File approval, it also strengthens the company's complex generics pipeline and regulatory track record.