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4. CMOs can help ensure regulatory compliance.
CMOs typically have strict quality control procedures in place, producing APIs to high standards in accordance with Good Manufacturing Practices (GMP).
Contracting API production to CMOs can help pharmaceutical companies bring drugs to market quickly. CMOs typically achieve faster manufacturing by leveraging streamlined processes and economies of scale when compared to in-house manufacturing.
CMOs manufacture a wide range of pharmaceutical products, including:
Active Pharmaceutical Ingredients (APIs)
Small Molecules
Generic Drugs
Biologics
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Biosimilars
Over-The-Counter (OTC) drugs
Pharmaceutical Intermediates
APIs refer to one or more active substances within a drug, while the drug is the final product administered to the consumer.
Pharmaceutical intermediates are chemical compounds synthesized during the API manufacturing process.
Intermediates are not intended for final use by consumers, but are essential components that are subjected to additional processing to manufacture the API. In contrast, APIs are biologically active compounds associated with the effect of the drug.
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