Cambridge Major Laboratories operates globally with multiple facilities in the U.S. and Europe. Each facility operates to the highest GMP standards, providing Active Pharmaceutical Ingredient (API) development and manufacturing services from early preclinical through post-NDA commercial manufacture.

Cambridge Major’s facilities are designed and engineered to supply APIs from concept to commercialization. With numerous R&D laboratories, GMP kilo lab suites, pilot and production plants, Cambridge Major can accommodate projects from a few grams to ton scale across a wide range of temperatures, pressures, and other reaction conditions.

Whether you are filing in the U.S. or developing new compounds for European or other markets, Cambridge Major can site your project in the location that best meets your needs. And, becauseCML is an integrated company, technical transfers happen seamlessly between sites, maintaining continuity of supply across facilities.

Cambridge Major – US
Cambridge Major Laboratories, Inc
W130 N10497 Washington Drive
Germantown, WI 53022
Tel: +1-262-251-5044
Fax: +1-262-251-5577Cambridge Major Laboratories’ US Development Headquarters is housed in a state-of-the-art 60,000 square foot GMP facility. The site has all of the capabilities required to provide API development and API manufacturing services from early pre-clinical to post-NDA commercial production. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics (-90C).

General features of the US Development Facility are as follows:

  • 4 Process R&D Laboratories (glassware to 50L)
  • 5 GMP Kilo Lab Suites (glassware to 50L)
  • 4 GMP Plant Process Areas (26 reactors from 50 gal to 500 gal)
  • 3 Separate Analytical/QC Laboratories
  • 3 HEPA Filtered Drying Suites
  • 1 HEPA Filtered Packaging Suite
  • ICH Stability Chambers
  • GMP Storage/Warehousing Areas

The facility incorporates all of the latest technologies for HVAC and Process control. The HVAC systems are controlled by a Building Automation System (BAS) which monitors the temperature, pressures and humidity of the processing areas (labs and plant). Each processing area contains its own Air Handling Unit with once-through air.

Cambridge Major – Europe
Cambridge Major Laboratories Europe, B.V.
Vliesvenweg 1
6002NM Weert, The Netherlands
Tel: ++31 (0)495 549 072 (Management, Peelterbaan)
Tel: ++31 (0)495 460 130 (General no. R&D + analytics + production facility)
Fax: ++31 (0)495 549 074

Cambridge Major’s European Headquarters is located in Weert, Netherlands. The Weert facility is a 12,500 square meter site specializing in medicinal chemistry, process development, scale-up, clinical supplies, and low volume commercial supply of API’s. The facility houses fully isolated pilot suites with reactors of up to 1000 liter, and is fully GMP and ISO14001 certified. The facility has a wide range of capabilities including plant scale cryogenics (-100C) and high temperature (300C), high pressure reactions and high vacuum distillations.

General features of the Weert, Netherlands facility are as follows:

  • 6 x Process R&D Laboratories
  • 6 x GMP Kilo Lab Suites
  • 4 x pilot plant suites (up to 1000 L)
  • Isolated Drying/Packaging Areas
  • Analytical Laboratories
  • ICH Stability Chambers

The facility incorporates all of the latest technologies for HVAC and Process control. The HVAC systems are controlled by a Building Automation System (BAS) which monitors the temperature, pressures and humidity of the processing areas (labs and plant). Each processing area contains its own Air Handling Unit with once-through air.