Our product, Aminocaproic Acid Injection USP, 5 g/20 mL (250 mg/mL), has received approval from the United States Food and Drug Administration (FDA) following successful completion of the related audit and evaluations as part of our marketing authorization application.
This approval will enable the commercialization of the product in the United States and is also expected to facilitate and accelerate our regulatory processes in other countries that recognize FDA approvals.
Any further developments regarding the process will be shared with the public.
