Process Development

Process Development
Product Description

Effective API process development integrates route design, process chemistry and manufacturability to establish scalable, controllable routes from early development through commercial readiness. It incorporates a risk‑based approach to technology transfer that proactively mitigates technical risk and sidesteps regulatory obstacles. 

Cambrex combines deep API process development and process chemistry expertise with integrated development and manufacturing capabilities to deliver robust, scalable processes across the full product lifecycle. Our approach to lifecycle management ensures that early development decisions are made with a forward‑looking perspective, supporting not only clinical progression but also long‑term commercial supply, regulatory success and post‑approval flexibility.

Learn more here: https://www.cambrex.com/drug-substance/custom-api-development/process-development/

Read more Show less

Cambrex Profarmaco Milano

  • Country/Region:
    Italy
  • On CPHI since:
    2024
  • Certificates:
    1
  • Employees:
    250 - 499
Company types
CMO/CDMO
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Generic APIs producer
View company profile
Categories
more categories Show less
Specifications
  • Supplied from
    Estonia; Italy; Sweden; United Kingdom; United States
More specifications Fewer specifications

Cambrex Profarmaco Milano

  • Country/Region:
    Italy
  • On CPHI since:
    2024
  • Certificates:
    1
  • Employees:
    250 - 499
Company types
CMO/CDMO
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Generic APIs producer
View company profile

More Products from Cambrex Profarmaco Milano (2)

  • Generic API Manufacturing

    Product Generic API Manufacturing

    As generic drug companies work to provide a reliable supply of finished drug products, Cambrex offers a robust library of APIs and intermediates, as well as quality, safety and supply security.

    Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. ...
  • Commercial API Manufacturing

    Product Commercial API Manufacturing

    When it comes to commercial API manufacturing, not all CDMOs are created equal. Manufacturing capacity is important, but so is the mission of the team working on your project. Are they completely invested in your success? Are they prepared to do whatever it takes to address the challenges that will inevita...

Cambrex Profarmaco Milano resources (2)

  • Cambrex High Point Completes FDA, PMDA and TGA Pre-Approval Inspections, Advancing Commercial Manufacturing Capabilities

    News Cambrex High Point Completes FDA, PMDA and TGA Pre-Approval Inspections, Advancing Commercial Manufacturing Capabilities

    Cambrex announced the successful completion of three Pre-Approval Inspections (PAIs) at its High Point, North Carolina facility by the U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Australia’s Therapeutic Goods Administration (TGA). The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan, and Australia, establishing the facility as the newest commercial manufacturing site within the Cambrex global network.
    26 Aug 2026
  • Generic API and Intermediate Product List

    Brochure Generic API and Intermediate Product List

    Cambrex is a leading global supplier of generic APIs. We work with generic drug companies well in advance of drug patent expiration, using high-quality, non-patent infringing processes to manufacture APIs. We produce over 90 generic APIs, intermediates, derivatives, and chiral compounds, including controlled substances.To see the complete list of the products we manufacture, download our full product list.