30 Aug 2011 11:46
Taihua plc
("Taihua" or the "Company")
Suspension of Licence
Taihua confirms that it has received notice today that following a recent audit of Taihua's facilities by representatives from the European Directorate of Quality Medicine ("EDQM") its Certificate of Suitability for Paclitaxel ("COS"), which was granted to Taihua by the EDQM on 28 September 2009, has been suspended.
The Company has been advised that the suspension is as a consequence of Taihua failing to satisfy EDQM as to the compliance with EDQM standards of certain areas of the Paclitaxel manufacturing process. However, Taihua have also been advised that they can apply for EDQM to revisit the site after the Company has rectified the areas of concern and, subject to the standards then being satisfied, the Certificate of Suitability will be reinstated.
The directors estimate this process will take approximately six months.
As Taihua is not currently supplying Paclitaxel into Europe this has no immediate impact on the Company and the Company intends to continue its conversations with potential distributors of Paclitaxel into Europe. Further updates will be provided when a distributor is appointed.
For more information please contact:
Nicholas Lyth, Taihua plc | 0776 990 6686 |
Katy Mitchell, WH Ireland Limited | +44 161 832 2174 |