IGMPI India

Ajinomoto Althea, Inc. is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto received its European GMP certificate from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations.

This certification provides clearance to the company to test commercial drug product for the European market. By issuing this 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 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. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing.