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API & Raw Materials

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China API & Raw Materials Suppliers

API:

Active Pharmaceutical Ingredient: 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. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance


Raw materials:

Pharmaceutical raw materials comprise substrates or elements that are used for manufacturing different types of drugs e.g. endocrine disorder drugs, musculoskeletal system drugs, anti-infective drugs viz. cephalexin, penicillin, ampicillin, cephradine, etc. Pharmaceutical excipients and ingredients or raw materials used to manufacture drugs are extracted form different types of sources. These sources could be natural or synthetic. Recently, many of the raw materials previously derived from natural sources are being produced synthetically in part or even bio-technologically. This is so because manufacturing them artificially is economical, safer, and much quicker. Pharmaceutical raw materials are manufactured using different types of acids, alcohols, esters, phenones, pyridines, etc.


Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include active pharmaceutical ingredients (API), also known as bulk active, are pharmaceutically active, and have the desired pharmacological effects on the body e.g. alvimopan, sparfloxacin, sapropterin dihydrochloride, lanreotide acetate, nicotinic acid, etc. In contrast pharmaceutical excipients are the pharmaceutically inert substances which help in delivering the active ingredient, e.g. antiadherents, binders, coatings, disintegrants, fillers, etc.

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