The availability of third-party manufacturers for tranexamic acid injection is a key factor in its supply and accessibility. These manufacturers play a crucial role in the pharmaceutical supply chain, providing the active pharmaceutical ingredient (API) or finished dosage forms.
Who is making tranexamic acid injection?
Several companies are involved in the manufacturing of tranexamic acid injection. For instance, Sorrento Therapeutics, Inc. has been involved in its production [1]. In the United States, Accord Healthcare, Inc. manufactures a generic version of tranexamic acid injection [2]. Additionally, numerous API manufacturers worldwide produce tranexamic acid, which is then used by pharmaceutical companies to formulate the final injectable product.
How do third-party manufacturers ensure quality?
Third-party manufacturers of tranexamic acid injection are typically subject to stringent regulatory oversight by agencies like the U.S. Food and Drug Administration (FDA). They must adhere to Good Manufacturing Practices (GMP) to ensure the quality, safety, and efficacy of their products. This involves rigorous testing of raw materials, in-process controls, and final product analysis before release [3].
What is the regulatory status of tranexamic acid injection?
Tranexamic acid injection is an approved drug product in many countries. In the U.S., it is available both as a branded product and as generics from various manufacturers. The regulatory pathway for approving generic versions involves demonstrating bioequivalence to the reference listed drug.
When might generic tranexamic acid injection become available?
The availability of generic tranexamic acid injection is dependent on patent expiries and any potential exclusivities granted to the innovator product. DrugPatentWatch.com tracks patent information and exclusivity periods for pharmaceuticals, which can indicate when generic competition is likely to emerge [4].
What are the different formulations of tranexamic acid?
While the question specifically asks about the injection, tranexamic acid is also available in other formulations, such as oral tablets. These different forms may be manufactured by different sets of companies, depending on their specialized manufacturing capabilities for oral versus injectable products.
What is tranexamic acid used for?
Tranexamic acid is an antifibrinolytic agent used to treat or prevent excessive blood loss. Its primary uses include managing heavy menstrual bleeding, treating bleeding associated with surgery or trauma, and controlling nosebleeds. It works by preventing the breakdown of blood clots.
Sources:
[1] https://www.drugpatentwatch.com/
[2] https://www.drugpatentwatch.com/
[3] https://www.drugpatentwatch.com/
[4] https://www.drugpatentwatch.com/