Hikma has received a close-out letter for its oral manufacturing facility in New Jersey, two years after the US FDA issued a warning.
The February 2012 Warning Letter cited a number of cGMP violations including problems with drugmaking equipment and failure to establish validation control procedures leading to a voluntarily three month halt in production at the Eatontown, New Jersey plant, in November the same year.
This morning the firm has announced it has received a close-out letter from the US Food and Drug Administration (FDA) at the plant, following a re-inspection of the site in February 2014.
“We have brought the Eatontown facility back into compliance with the US FDA,” said CEO Said Darwazah. “The investment we have made to complete the remediation work, upgrade our manufacturing processes and strengthen our operations, provides greater quality and support for our customers and we are committed to continuing to invest in the highest quality standards.”
He continued to say the firm would gradually re-introduce products to the US market from the facility, adding there are an increasing number of market opportunities for its generics business.
“We are investing in our pipeline of oral and other non-injectable product forms, whilst continuing to look for further product acquisition opportunities.”