Hikma Pharmaceuticals has received a letter from the US Food and Drug Administration (US FDA) closing out the Warning Letter it received in October 2014 in respect of its injectables manufacturing plant in Portugal, thus bringing it back into compliance with the US FDA.
Said Darwazah, Chairman and CEO Hikma
Hikma said in an announcement on Wednesday that the letter demonstrates that the corrective actions that were taken in response to the Warning Letter were fully reviewed and accepted by the US FDA.
Said Darwazah, Chairman and Chief Executive Officer of Hikma commented: “I am very pleased that we have brought our Portuguese facility back into compliance with the US FDA. We have worked very hard to meet the FDA’s requirements and remain committed to maintaining the highest standards of quality and compliance across all our facilities.”
“We believe that the resolution of the Warning Letter will enable us to accelerate the introduction of new products to the market, ensuring we continue to broaden the range of critical medicines we supply to patients in the US.”