Regulators approve Ubichem for commercial cGMP API production
Ubichem Research 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.
"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.
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