18th Nov 2015 07:07
LONDON (Alliance News) - Hikma Pharmaceuticals PLC on Wednesday said it has received a letter from the US Food and Drug Administration closing out a previous warning letter it had received from the regulator.
FTSE 100-listed Hikma said the letter closes out the warning letter is received from the FDA in October 2014 regarding its injectables manufacturing plant in Portugal.
The company said the FDA has accepted the remedial actions it took to fix the problems at the manufacturing plant, which had centred on environmental monitoring issues.
"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," said Hikma Chairman and Chief Executive Said Darwazah.
By Sam Unsted; [email protected]; @SamUAtAlliance
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