Cambrex to provide pharma development services
Cambrex Corporation, best known as a manufacturer of active pharmaceutical ingredients (APIs) for pharmaceutical and generic companies, has completed a $11.5 million capital expansion to support the growing market demand for custom development and generic API. The new facilities have been validated for FDA current good manufacturing practices (cGMP) and has started taking on new projects.
Commenting on the increasing demand driving growth for custom development projects, James A. Mack, Cambrex Chairman & CEO is confident the extra capacity "will enable Cambrex to be even more responsive to customers’ need to shorten their development timelines."
Mack confirmed the facilities will be used to develop new generic APIs. "Cambrex custom development services include chemical route selection, process development and optimization, and manufacturing and validation services to support customers’ clinical trials of new drug candidates."
The new capacity includes a small-scale API manufacturing facility in the US and a custom manufacturing production line and upgrade of R&D and quality control laboratories in Europe.
The European expansion includes enhanced GLP facility within the existing labs plus extra space for research chemists at the Cambrex facility in Karlskoga, Sweden. A new production line, also in Sweden, supports a larger customer’s need to have production locations in both Europe and North America.
A new, small-scale facility at Charles City, Iowa provides extra capacity for the controlled substances and other small-scale APIs. This will also ease a bottleneck in the Charles City cGMP pilot plant that was taken up for the last 18 months producing commercial quantities of a product for attention deficit disorder.
Cambrex custom development services will provide the resources that pharma customers may not have in-house when they need them. The development services provide customized solutions to meet individual needs. Custom development is seen as a strategic growth area for Cambrex. Demand for custom development projects is less dependent on FDA approval while it driven by the strong pipeline of new drugs in development and clinical trials.
The US facility will also support early development of generic active pharmaceutical ingredients outside of Europe where the company is not restricted by Supplementary Protection Certificate legislation.
Further information about Cambrex
Keywords : Cambrex Corp Pharmaceutical development services Strategic growth Capacity API custom manufacturing FDA cGMP
