Cambrex Completes New Quality Control Laboratory for Generic API Development in Milan
Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it had opened a new 120m2 quality control (QC) laboratory at its site in Paullo, Milan, Italy. The laboratory expands on the current QC facilities that analyze and test its generic API portfolio of products during development and manufacturing. The QC laboratory is now fully operational, having been authorized by the Agenzia Italiana Del Farmaco (AIFA).
The additional laboratory space will increase the efficiency of the QC department as the site expands the number of generic APIs in development. New instruments, including a polarimeter and infrared spectrometer, have been added, with the systems linked to secure, electronic data capturing software to allow full traceability in line with regulatory requirements.
“Our facility in Milan is the center of the Cambrex’s generic API business, and this investment is the latest in a number of steps we have taken at the site to increase its efficiency and flexibility as we look to grow the portfolio of products that we offer,” commented Aldo Magnini, Managing Director, Cambrex Milan. “In the last year the company has made strategic investments to expand its capabilities in research and development, manufacturing, and now QC capabilities, as we look to take advantage of the opportunities that are arising in the generic market.”
Cambrex manufactures over 70 generic APIs which are produced to cGMP standards at the Milan site, where seven production departments are supported by a pilot plant, kilo scale plant and development and analytical laboratories.
Cambrex is the leading small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. The company provides customers with an end-to-end partnership for the research, development and manufacture of small molecule therapeutics. With over 35 years’ experience and a growing team of over 2,000 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuous flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including oral solids, semi-solids and liquids and has the expertise to manufacture specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments. For more information, please visit www.cambrex.com
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