Apixaban API was developed at Minakem’s Canadian facility (Delmar Chemicals Inc.) in 2016. Apixaban API CAS number is 503612-47-3
From a regulatory perspective, Minakem offers:
– An American DMF (Drug Master File) #30633
– A European DMF (CEP) expected in 2026 (Pharmacopea under evaluation).
Minakem’s Apixaban API brings:
– polymorphism form N-1
– a selective granulometry (PSD) to facilitate your formulation
– High-quality production standards.
Therapeutical Class and Mechanism of Action
Apixaban API is an anticoagulant that was approved under the trade name Eliquis in Europe in 2011 and in the United States in 2012.
It functions by inhibiting Factor Xa, which reduces thrombin generation and helps prevent the formation of blood clots (thrombus). It leads to an effective anticoagulation without directly affecting platelet aggregation.
About Minakem Montreal’s Expertise
Minakem Montreal (Delmar chemicals Inc.) has been manufacturing Active Pharmaceutical Ingredients (APIs) since 1941. It is the largest API facility in Canada, benefiting from a strong scientific and technological environment. Located close to its U.S. customers in the New Jersey and Boston areas, Montreal also has a strong tradition of serving the entire North American market, as well as Latin America, Europe, Japan, China, and India.
About Minakem’s Network
Minakem Montreal works daily with Minakem’s other European facilities, leveraging their complementary expertise, such as solid engineering, analytics, global regulatory affairs, and capabilities to optimize competitiveness.
Minakem has over 40 years of expertise in developing, scaling up, registering DMFs, and manufacturing complex APIs, including chiral small molecules, steroids, and highly potent APIs (HPAPIs, primarily used in oncology treatments).
Strong supply chain performance is becoming critical to our customers’ success.
Minakem’s operations focus on producing safe products for patients, achieving high OTIF performance, providing strong quality support, and consistently seeking solutions to meet customers’ unexpected market demands.
More data on Apixaban API
Apixaban’s data are available on Pharmaoffer.
Apixaban additional data are available on Wikipedia
-
Category
-
CAS NO.
503612-47-3
-
Regulatory Documentation
USDMF
-
Certificates
GMP
USFDA audit
Nitrosamines
TSE/BSE
Non GMO
Hallal
-
Structure