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Pharmaceutical raw materials
Various raw materials are used in pharmaceuticals industry. These raw materials are generally classified into Active Pharmaceutical Ingredient (API) and additives.
Active Pharmaceutical Ingredient (API)
Active pharmaceutical ingredient (API) is the active component of a drug. The ICH Q7 GMP Guideline defines API as “any substance or a mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.” A material produced during steps of the processing of an API is called an “intermediate.”
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Some of our manufacturing and contract services are performed at the factories of our affiliated company, FUJIFILM Wako Chemical Corporation.
Additives
Pharmaceutical ingredients of a drug product include not only an API, but also stabilizers that improve stability of the finished product, coating agents that makes the product easier to ingest by blocking tastes and odors caused by drug substances or are used for specific purposes of drug administration such as to protect from gastric degradation and ensure enteric drug release for action, and excipients that are used to make formulation easier in adjusting the size and shape of the finished product. These agents are collectively called “additives.”
Because pharmaceutical products affect the structure and function of the body, appropriate quality control is required not only for the API but also for the additives.
We offer a diverse lineup of additives properly managed in accordance with regulations such as GMP and ISO9001.
