Ajinomoto Althea Inc., a San Diego-based provider of biopharmaceutical contract development and manufacturing services, has received its European certificate of good manufacturing practice, the company announced Wednesday.
Known as the European GMP, the certificate was issued by the Medicines and Healthcare products Regulatory Agency, a government agency in the United Kingdom. According to a release, the MHRA conducted an on-site inspection of Ajinomoto Althea's operations on June 19, yielding no critical or major observations. The certification provides clearance for Althea to test commercial drug products for the European market. By issuing the certification, the MHRA officially recognizes that Althea's quality control testing and overall quality systems are in strict compliance with the European GMP requirements.
"Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the U.S. and now are very pleased to expand our commercial testing capabilities for European clients," David Enloe, president and CEO of Althea, said. "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."