Withdrawal of COS16 Sep 2011 17:45
Further to the announcement dated 30 August 2011, Taihua confirms that it has received a formal update from the European Directorate of Quality Medicine ("EDQM") concerning its Certificate of Suitability for Paclitaxel ("COS"). The EDQM have withdrawn Taihua's Certificate of Suitability following non-compliance with a number of critical standard operating procedures. The Company intends to reapply for the Certificate of Suitability but there can be no guarantee in terms of the timing of this process. As Taihua is not currently supplying Paclitaxel into Europe this has no immediate impact on the Company. However Taihua has suspended conversations with potential distributors of Paclitaxel into Europe pending clarification of the position. The Company anticipates releasing its interim results for the period ended 30 June 2011 on 19 September 2011. Nick Lyth, Chairman of Taihua plc, said: "Having been verbally notified of a suspension of our Certificate of Suitability immediately following the audit, the Board were very surprised to receive notification of the withdrawal today. The management of the Company will meet with their application agent, Beijing Canny, early next week to discuss whether to appeal this decision. In the event that an appeal is not appropriate, the Company will reapply for the Certificate of Suitability as it continues to seek long term opportunities in supplying Paclitaxel API and injectables into the regulated market.
A detailed plan will be formulated following meeting with Beijing Canny.