Hikma Pharma’s Portugal plant cleared by FDA

Jordon-headquartered Hikma Pharmaceuticals (LSE: HIK) revealed today that it has received a letter from the US Food and Drug Administration closing out the Warning Letter it received in October 2014 in respect of its injectables manufacturing plant in Portugal.

This letter demonstrates that the corrective actions that were taken in response to the Warning Letter were fully reviewed and accepted by the US FDA, the company noted. The warning related to investigations and environmental monitoring at the company's plant in Portugal, where it produces powder, liquid and lyophilized injectable drugs. Shares of London-listed Hikma moved up 2.4% to 2,000.00 pence in mid-morning trading.

Said Darwazah, chairman and chief executive 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.”