tranexamic acid Injection 500 mg, 1 g
Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP, EU GMP
Manufacturer #33498
The company focuses on reformulating and repurposing existing drugs to create innovative treatments, primarily through "505(b)(2)" applications. This strategy leverages existing safety data, resulting in reduced clinical trial costs, shorter development timelines, and lower risks compared to developing new drugs. The company's portfolio includes 18 reformulated and repurposed medicines, with Sotalol IV for atrial fibrillation and Maxigesic® IV for non-opioid pain management in early commercialization. Additionally, the company has launched one high-barrier generic product in the US, with two more in development, all aimed at addressing unmet medical needs and improving patient outcomes.
Tranexamic acid is a coagulation modifier class medication that is used to prevent blood loss after major trauma, factor IX deficiency, hemophilia type A, melasma, nosebleeds, menorrhagia, and menstrual disorders. Manufacturing companies produce it as both standalone medication and in combination drug formulations, along with ingredients such as etamsylate and mefenamic acid.
Suppliers market it in the forms of 100mg/ml solution for intravenous injection and 500mg tablets.
In use for over 50 years, tranexamic acid is an inexpensive and widely used treatment. The World Health Organisation has included it in its list of Essential Medicines that contains the safest and most effective drugs recommended for a health system. Major pharmaceutical manufacturers and supplies of tranexamic acid include Pfizer and Sanofi-Aventis.
Tranexamic acid is available in both trade name and generic formulations. Buyers are advised that online sellers may attempt to market fraudulent versions of the generic drug, whereas Pipeline Pharma, through its pre-auditing and quality control procedures ensures that only verified manufacturers and wholesalers enter our online marketplace, offering you a risk-free B2B pharmaceutical sales platform.