Oral anticoagulants, previously limited to vitamin K antagonists like warfarin, have seen a revolutionary shift with the introduction of direct oral anticoagulants (DOACs) like apixaban, dabigatran and rivaroxaban. DOACs have more favorable efficacy and safety profiles compared to warfarin and serve as lifelines for millions of patients with atrial fibrillation. They also provide a secure and highly effective alternative that eliminates dietary restrictions and reduces the need for in-clinic injections. However, as blockbuster medicines without generic alternatives, these modern anticoagulants can present accessibility challenges for patients when needed most.

USP’s standards and solutions – well accepted by regulators worldwide – are critical for accelerating drug development and minimizing risk for manufacturers seeking product approval in the anticoagulant space.

Click below for USP Reference Standards for APIs and impurities, Pharmaceutical Analytical Impurities* (PAIs), nitrosamine impurities, excipients, and monographs in USP−NF for the following drugs:

*Pharmaceutical Analytical Impurities are released using a process developed by USP’s subject matter experts. The release process is based on internal policies, standard operating procedures, and requirements as defined by USP’s Quality Management System. USP is an ISO 9001:2015 certified facility. PAI products are different from official USP Reference Standards. PAI products are not required for compendial compliance.

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