Active Pharmaceutical Ingredients, or APIs, are the part of the drug/treatment that offers the desired medicinal effect. Most drugs are made of an API and excipients. Excipients are usually inert but add desirable properties to the drug such as taste-masking, delayed-release, etc.
API manufacturing service providers can offer a wide variety of services including; Pre-clinical samples, development of reliable and scalable routes including process economies assessment, regulatory strategies establishment and a reduction in Cost of Goods (COGS) studies, synthetic and process chemistry and analytical method development, analytical method qualification/validation and preliminary stability profile, non-GMP and cGMP Scale-up, IND document preparation & review (CMC or DMF preparation), and full-scale commercial manufacturing.