Hikma announces successful resolution to FDA warning letter at its Portugal facility


Will enable Hikma to accelerate the introduction of new products to the market

Hikma Pharmaceuticals, a Jordan-based multinational pharmaceutical group, has received a letter from the US Food and Drug Administration closing out the warning letter the firm received in October 2014 in respect of its injectables manufacturing plant in Portugal.

The plant, located in Terrugem, which produces powder, liquid and lyophilised injectable drugs for the US and EMEA markets, was inspected by the US regulator in March 2014. During the inspection the FDA identified 'significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals'.

The corrective actions taken by Hikma in response to the warning letter were fully reviewed and accepted by the US FDA, the firm said.

Said Darwazah, Chairman and Chief Executive of Hikma said: '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.

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'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.'