• News
  • SAN DIEGO
  • Health

Ajinomoto Althea certified in Europe for manufacturing practices

Related Special Reports

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."

Leave Your Comment

Comments are moderated by SDDT, in accordance with the SDDT Comment Policy, and may not appear on this commentary until they have been reviewed and deemed appropriate for posting. Also, due to the volume of comments we receive, not all comments will be posted.

SDDT Comment Policy: SDDT encourages you to add a comment to this discussion. You may not post any unlawful, threatening, defamatory, obscene, pornographic or other material that would violate the law. All comments should be relevant to the topic and remain respectful of other authors and commenters. You are solely responsible for your own comments, the consequences of posting those comments, and the consequences of any reliance by you on the comments of others. By submitting your comment, you hereby give SDDT the right, but not the obligation, to post, air, edit, exhibit, telecast, cablecast, webcast, re-use, publish, reproduce, use, license, print, distribute or otherwise use your comment(s) and accompanying personal identifying and other information you provide via all forms of media now known or hereafter devised, worldwide, in perpetuity. SDDT Privacy Statement.

User Response
0 UserComments

Leave Your Comment

Comments are moderated by SDDT, in accordance with the SDDT Comment Policy, and may not appear on this commentary until they have been reviewed and deemed appropriate for posting. Also, due to the volume of comments we receive, not all comments will be posted.

SDDT Comment Policy: SDDT encourages you to add a comment to this discussion. You may not post any unlawful, threatening, defamatory, obscene, pornographic or other material that would violate the law. All comments should be relevant to the topic and remain respectful of other authors and commenters. You are solely responsible for your own comments, the consequences of posting those comments, and the consequences of any reliance by you on the comments of others. By submitting your comment, you hereby give SDDT the right, but not the obligation, to post, air, edit, exhibit, telecast, cablecast, webcast, re-use, publish, reproduce, use, license, print, distribute or otherwise use your comment(s) and accompanying personal identifying and other information you provide via all forms of media now known or hereafter devised, worldwide, in perpetuity. SDDT Privacy Statement.