Contracted Drug Production

A Contract Development and Manufacturing Organization' ('CDMO'), 'sometimes called a' Contract Manufacturing Organization' ('CMO'), is an organization that serves the pharmaceutical industry and provides clients with comprehensive services from drug development through manufacture .Services offered by CDMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials,  Outsourced drug producing late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial production. Outsourcing to a CDMO allows the pharmaceutical client to expand its technical resources without increased overhead. The client can then manage its internal resources and costs by focusing on core competencies and high-value projects while reducing or not adding infrastructure or technical staff. 

In particular, our new investigation benefits your research, planning and decisions through the following analyses:

Revenues to 2025 for the world pharma contract manufacturing organisations (CMO) market - discover that industry's prospects overall and by submarket, finding promising segments for investments, developments and revenue growth

Profiles of 30 leading companies there - assess services, strategies, sales results and outlooks, gaining revenue forecasts to 2025 for 26 of the firms, also with some profitability predictions

This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing  of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. This guidance applies to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), finished drug products, combination products, and biological drug products  For the purposes of this guidance, the term “manufacturing” includes processing, packing, holding, labelling operations, testing, and operations of the Quality Unit.

  • Discover trends and segments with the highest revenue potential
  • Analysis of what stimulates and restrains the contract drug production market
  • Outsourced drug producing
  • Demand for formulation developing services
  • Trends for investing in biopharma manufacturing

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