The local independent drug-formulation development and manufacturing company has received certification of compliance with European Union (EU) Good Manufacturing Practice (GMP) regulations.
This broad certification, which was granted by
“The strategic addition of this certification—combined with new capabilities such as high-potency spray-drying and future commercial spray-drying—strengthens Bend Research’s position as a preferred provider for oral solubilized, modified-release, inhalation, and many other dosage forms,” said Rod Ray, Bend Research CEO.
“We knew the EU’s quality standards were stringent, but we were confident that our operations met those high standards and were eager to demonstrate that to our customers,” Ray said.
In 2012, Bend Research produced clinical supplies for 16 clients, 37 chemical compounds and 136 clinical manufacturing lots. Many of these involved the use of advanced dosage forms designed to increase the exposure of low-solubility compounds or provide modified-release delivery profiles.
Bend Research requested the voluntary inspection by the MPA and certification was granted after an audit of operations by the MPA. Bend Research Receives EU Certificate of GMP Compliance
