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Overview of GMP contract manufacturing of APIs, from clinical production to commercial manufacturing, by contract manufacturing organizations (CMO).
Q1. What is API contract manufacturing?
Contract manufacturing pertains to outsourcing a part or the entirety of the drug manufacturing process of a product, which was likely performed in house, to a third-party contract manufacturer. Nowadays, outsourcing activities like the design, production, assembly, and distribution of products to contract manufacturers has become commonplace in the pharmaceutical industry.
Contract manufacturing is beneficial for customers as it provides them a guaranteed supply of drug products from clinical production to commercial manufacturing under integrated cGMP and pre-GMP manufacturing operations. Furthermore, it enables companies to focus on selling and marketing products instead of focussing on the drug manufacturing process itself.
Pharmaceutical contract manufacturing organizations including CMOs and CDMOs can provide such contract manufacturing and analysis services. At times, pharmaceutical contract manufacturing organizations can be specialized in custom synthesis or API synthesis, chemical synthesis of small molecules, and custom API manufacturing services.
- Custom Synthesis of Small Molecules: Small molecules are low molecular weight molecules that include lipids, monosaccharides, secondary messengers, other natural products and metabolites, as well as p