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September 19, 2016
The European Medicines Agency (EMA) announced on Sept. 16, 2016 that the agency was recommending that non-critical drugs manufactured by Pharmaceutics International Inc. (Hunt Valley, MD) no longer be available in the European Union, except for Ammonaps (sodium phenylbutyrate), because of failures in good manufacturing practices (GMPs).
Inspections by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA found that the company had not properly implemented corrective measures agreed upon after an earlier inspection of the company’s facility. A lack of quality assurance and the potential for cross contamination were some of the agencies’ concerns.
EMA stated in a press release that although no defects have yet to be found in product, the agency’s Committee for Medicinal Products for Human Use (CHMP) decided to stop the supply of non-critical products from the US company as a precaution. CHMP advised the company to implement the proper corrective actions to be in compliance with GMP.
Ammonaps, which treats urea cycle disorders, will remain available in the EU where alternative treatments do not exist, but will be recalled in countries where other treatments are available. The company’s vitamin D deficiency medication, SoliCol D3, will not be approved for marketing in the EU until the company proves GMP compliance. Some of the company’s products that are manufactured at alternative registered facilities will remain available in the EU.