Commercial API Manufacturing

Commercial API Manufacturing
Product Description

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 inevitably arise?

At Cambrex, small molecule API manufacturing — at all phases, from preclinical to commercial — has been our specialty for more than 40 years. With our “expect-the-unexpected” mindset and collaborative approach, we are uniquely qualified to help you deliver a reliable supply of API built on safe and robust processes. This is only enhanced by our uncompromising commitment to cGMP standards and proven compliance track record.


Learn more here: https://www.cambrex.com/drug-substance/custom-api-manufacturing/commercial-api-manufacturing/

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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
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Specifications
  • Supplied from
    Italy; Sweden; 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

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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.