About Ferric Carboxymaltose API
Therapeutic CategoryNephrology
CAS Number
9007-72-1
API Technology
Iron Product
Dose Form
Injectable
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, China DMF, Malaysia DMF, Saudi Arabia
Mechanism of Action
Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.
Indication
Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:
- Who have intolerance to oral iron or have had unsatisfactory response to oral iron;
- Who have non-dialysis dependent chronic kidney disease.
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Related Resources
Colloidal Iron Complex Formulations – Understanding and Developing the Process
This whitepaper describes the challenges involved in developing iron-carbohydrate complexes, including the parameters required to demonstrate physicochemical equivalence and summarises our expertise in addressing them. Iron carbohydrate complexes are a hybrid of inorganic and organic molecules. The molecule's key structural elements are architected /governed by the defined process unit operations and materials used in the process. Any subtle variation in the process unit operation can alter the structural features of the iron carbohydrate complexTo continue reading, please fill in the contact form below
