The facility consists of R&D Laboratory, Kilo Laboratory and eleven manufacturing units where products primarily for the pharmaceuticals industry are produced.

R&D Laboratory

The facility includes Research & Development Laboratories with an extensive range of equipment. We develop and optimize processes and analytical methods for active pharmaceutical ingredients and intermediates ("starting materials" for the production of finished substances) to meet our customers’ requirements. Analytical Quality Control is also located in this department.

Kilo Laboratory

We have a cGMP kilo laboratory, which was built in 1999. It has two 50 liters reactors, one 100 liters reactor, and a fluid bed dryer placed in environmentally controlled areas for pharmaceutical ingredients and intermediates.

Pilot Scale

Cambrex Karlskoga has four (4) Pilot Plants (cGMP). The plants are used for both Process Piloting and Small Scale production with a total reactor capacity of 24 m3.

Full Scale

We have seven (7) full scale plants and 14 production trains with a total reactor capacity of 300 m³.

New cGMP plant ready in 2009!
Cambrex is currently investing approximately $20MM USD (140 MSEK) in a new multipurpose API production facility. The plant will be completed by the end of 2008 and ready for production in January 2009. There will be two flexible cGMP production lines, one mid-sized (2.5 m3) and one full-scale (6 m3). 

Regulatory

Manufacturing operations for API’s and related intermediates, whether at full scale or in the pilot plants, strictly adhere to cGMP as defined in the ICH Q7 Guideline “Good Manufacturing Practice” for Active Pharmaceutical Ingredients, recognized and accepted by the USA, EU and Japan.

The site is FDA registered and during the last two inspections, (November 2002 and September 2005) no 483 observations were issued. The Swedish regulatory agency, MPA (Medical Products Agency), performed a GMP inspection in November 2005 and a GMP certificate was issued. The facility is also certified according to ISO 9001.

Every year numerous customers and regulatory agencies conduct successful quality audits of our facilities. We ensure all of our employees undergo continuous training and remain dedicated to delivering the highest standards of maintaining cGMP, safety and environmental compliance.