What is a CDMO?
A CDMO is a contract development and manufacturing organization. It develops the process for making a drug and then makes the drug for another company, under contract. The company that owns the drug is usually called the sponsor or the client.
Development and manufacturing
Development work turns a molecule into something that can be made the same way every time. It covers process development, analytical method development, formulation, and the stability studies that show how the product holds up in storage.
Manufacturing work makes the material itself: batches for toxicology studies, for clinical trials, and, once a product is approved, for sale. Drug substance is the active ingredient. Drug product is the finished form a patient receives, such as a filled vial, a prefilled syringe, or a tablet. Some CDMOs make both. Others do one and hand over to a partner for the other.
Contract manufacturers and CROs
A contract manufacturing organization, or CMO, makes material to a process that someone else developed. The word CDMO came into use as manufacturers added development services, and many companies now use the two terms loosely.
A contract research organization, or CRO, runs studies and tests rather than making the drug. A CRO might measure drug levels in blood samples or run a clinical trial. A CDMO makes the material those studies use. Some companies offer both kinds of work, often at different sites.
Modality matters
Small molecules are usually made by chemical synthesis. Biologics, such as antibodies and other proteins, are made in living cells and need bioreactors, purification suites, and their own analytical methods. Cell and gene therapies need different facilities again. A CDMO that is strong in one modality may not offer another, so start from the type of molecule you have.
What stays with you
Manufacturing for medicines is done under good manufacturing practice, the quality rules that regulators enforce. The CDMO runs its plant to those rules and regulators inspect it. You still own the product and its regulatory filings, and you remain responsible for what goes to patients. A quality agreement between you and the CDMO writes down which party does what: who releases batches, who handles deviations, and who talks to regulators.
Using the manufacturing lists
Each entry on a manufacturing list quotes what the site publishes about its work. Read the quote and follow the source link before you contact anyone.