CDMO

CDMO: Contract Development and Manufacturing Organization

Fulton, a European pharmaceutical company, is a Contract Development and Manufacturing Organization (CDMO), i.e. a service and product company for the pharmaceutical industry that deals with all phases of the drug manufacturing cycle: from idea generation and design, to development, production, and the ‘licensing out’ of finished products. 

Fulton collaborates in the development and manufacturing of drugs and medical devices, as CMO and/or CDMO, for large, medium and small Italian and foreign pharmaceutical companies, operating worldwide.

CDMO e CMO: services compared

CDMO meaning: CDMO stands for Contract Development and Manufacturing Organization. A CDMO, specializing in contract development and manufacturing, accompanies its customers through the different phases of drug development.

CMO meaning: CMO stands for Contract Manufacturing Organization, i.e. a company specializing in the production process of a drug already on the market. The main objective of a CMO is to optimize and complete the manufacturing of a drug product for its customers.  

In both cases, it is a process that enables collaboration with specialists, reducing manufacturing costs and the time to market. Drug Products produced by CDMOs and CMOs do not show their own name on the label. In this case, Drug Products are made under private labeling.

The advantage of companies turning to CMOs and/or CDMOs is that they can focus on their core competencies by outsourcing the management of critical aspects of the development and manufacturing process to experienced and recognized professionals.

Fulton offers both CMO and CDMO support.

How to find the right CDMO and CMO for your project?

In an ever-changing pharmaceutical world, choosing the right Contract Development and Manufacturing Organization (CDMO) is critical to successfully navigate the complex process of drug development and manufacturing.

  1. Compliance and Reliability:  It is vital to check the company’s history of compliance with pharmacovigilance standards. Checking deficiency letters from regulatory bodies, both Italian and international, can be an indicator of potential reliability and compliance problems.
  2. Excellence and Innovation: The quality of CDMO’s work is equally crucial. Recognized quality certifications and patents are the symbol of company’s commitment to excellence and innovation in its field.
  3. Provided Services: Make sure that the CDMO offers exactly the services you need. This includes not only the dosage form (i.e. suppositories, syrups, etc.), but also the specific steps in the production and development process that it can handle.
  4. Experience: The CDMO’s know-how in your specific sector or with similar products can make a big difference in terms of project efficiency and success.
  5. Facilities Inspection: If possible, planning a visit to CDMO facilities can provide valuable insights into the quality of equipment, the effectiveness of operating procedures and the staff expertise.

Assessing these aspects carefully will help you to make an informed choice, establishing a productive partnership with your CDMO. This is a pivotal step for the success of your pharmaceutical projects.