Ajinomoto Althea, Inc. has received its European GMP certificate from the Medicines and Healthcare products Regulatory Agency (MHRA) following an on-site inspection on June 19, 2014 that resulted in no critical or major observations. The certification allows the company to test commercial drug product for the European market.
"Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the US and now are very pleased to expand our commercial testing capabilities for European clients," said David Enloe, president and chief executive officer of Althea. "Knowing that our testing and quality processes meet both the stringent FDA and EMA quality requirements really signifies a great accomplishment by our team and supports our leadership position in the CMO market."
Althea provides manufacturing services including cGMP bulk manufacturing filling in vials and syringes, microbial-based biologics manufacturing, Crystalomics crystal suspension technology, process development, in-process and release testing analytics, equipment qualification, and validation.