Onyx Scientific achieves MHRA approval for API manufacture

Published: 7-Jul-2004

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved outsourcing specialist Onyx Scientific for the manufacture of active pharmaceutical ingredients following a voluntary inspection carried out in April.


The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved outsourcing specialist Onyx Scientific for the manufacture of active pharmaceutical ingredients following a voluntary inspection carried out in April.

The approval confirms that Onyx's operations are 'in general compliance with the principles of Good Manufacturing Practice as laid down in Annex 18 of the EU Guide to GMP'.

'This will provide additional reassurance for our customers that we are able both to make and to handle new APIs and meet both European and US regulatory requirements,' said ceo Dr Tony Flinn.

Onyx Scientific provides contract research, custom synthesis, small-scale cGMP manufacturing and other services plus novel fine chemicals based on proprietary technology.

  

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