Regulators approve Ubichem for commercial cGMP API production

Ubichem Research* (Eastleigh, UK and Budapest, Hungary) has successfully completed its first regulatory audit and is now approved by OGYI (Hungarian National Institute for Pharmacy) for the commercial supply of cGMP Active Pharmaceutical Ingredients (APIs). Reciprocal agreements mean that this approval is effective throughout the EU.

Announcing the milestone at the recent InformexUSA 2007 conference in San Francisco, Roger McDonald, director, Ubichem Research, commented:

“This is a fantastic achievement, a real testament to the skill of our dedicated team in Budapest. Having been manufacturing quantities of API for clinical trial, this approval represents a major step forward in our business and is a clear demonstration of our commitment to quality – allowing us to support our pharma and biotech clients all the way from candidate nomination to market.”

A $1-million investment in new and upgraded analytical, development and production capacity is already underway at the company’s facilities. This is expected to be completed during 2007.

* Ubichem Research Kft is the custom synthesis and manufacturing arm of Ubichem Plc UK