Pharming's Rhucin production facilities pass EMEA inspections |
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Published
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Fri, 13 Jul 2007 07:39
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AMSTERDAM (Thomson Financial) - Dutch biotechnology company Pharming Group NV said today that its facilities for the manufacturing of its lead product Rhucin have successfully passed all inspections conducted by the European Medicines Evaluation Agency (EMEA).The company said the EMEA has confirmed that all facilities and processes involved in the production of Rhucin operate according to the standards of Good Manufacturing Practice (GMP) for pharmaceutical production.Pharming said obtaining GMP status is a key step in the approval process for Rhucin, and reiterated its anticipation that the EMEA's scientific committee will present an opinion on Rhucin in the second half of 2007.The company also said it still expects to finalise clinical trials of the drug in the US in the second half of the year.Dave van Ginhoven, dave.vanginhoven@thomson.comdvg/lamCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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FDA, EU, EMEA expand cooperation to pediatrics, orphan drugs 