Onyx Scientific has been cleared by the UK authorities for the manufacture of active pharmaceutical ingredients, and says that this approval is one of the first of its kind for a firm supplying early development quantities of APIs.
The validation comes after a voluntary inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) confirming that the company's operations are "in general compliance with the principles of Good Manufacturing Practice."
"This is excellent news for us," commented Onyx's chief executive officer Dr Tony Flinn, "and will provide additional reassurance for our customers that we are both able to make and handle new APIs and meet both European and US regulatory requirements."
Onyx Scientific is a chemistry outsourcing specialist that supplies a diverse array of chemistry research and development services to the pharmaceutical and related industries, including contract research, custom synthesis, small-scale cGMP manufacturing and other services, plus novel fine chemicals based on proprietary technology.
In April, the company opened a new laboratory complex, increased its capacity by 30 per cent in response to what it said was growing demand from existing and new customers for high quality contract research projects in the drug discovery area.