Hikma Pharmaceuticals is back in compliance with the U.S. Food and Drug Administration after it received a warning letter from the agency in 2014.
The company recently received another letter that closed out the warning letter after it took steps to rectify the situation at its manufacturing plant in Portugal, which focuses on injectables.
"I am very pleased that we have brought our Portuguese facility back into compliance with the U.S. FDA,” Said Darwazah, chairman and chief executive officer of Hikma, said. “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 U.S."