An Active Pharmaceutical Ingredient (API) is by the U.S. Food and Drug Administration defined as the following: Any substance or 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. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.
API Production Methods
API’s main methods to manufacture API’s are chemical synthesis and fermentation.
Chemical synthesis：Most API’s are produced by chemical synthesis, from a range of compounds. Chemical synthesis involves highly complex chemistry, equipment and procedures.
Fermentation：the fermentation process enables living microorganisms to produce the desired active ingredient.
Developing and producing Active Pharmaceutical Ingredients (APIs) include a various processing steps, such as reaction, crystallization, separation and purification, filter cake washing, solvent swap and solvent exchange.
Preparation – foundation of successful production
Reaction – from process to product
Separation and purification – step by step to a pure active ingredient
Conditioning – the perfect finish
In the central process of drug synthesis, the highly diverse reactions, reactor types and reaction rates demand the maximum of flexibility from the processing plant. Only in this way can reactions that run in parallel and sequentially be properly coordinated. And only in this way can the requirements for safety, reaction kinetics, heat transfer and mass transfer be met.
In the separation and purification steps, the last impurities must be removed from the active ingredient; whether by filtration, crystallisation, milling, sieving, drying, centrifugation or by combinations of several methods.
The better the preparation, the better the product. This is not just about preparation of the quality-controlled raw materials by weighing, milling or mixing, but also about the GMP-compliant, documented execution of all part processes with the correct ingredients – at the right time and in the right quantity and quality.
If you are interested in working in close co-operation with our professional and friendly team, please contact us – We would be delighted to answer your questions, queries or enquiries. Mosinter is a professional chemical raw materials manufacturer in China, we adopt advanced technology to optimize the process of Active Pharmaceutical Ingredient Production.