2nd Apr 2014 07:47
LONDON (Alliance News) - Hikma Pharmaceuticals PLC said Wednesday the US Food and Drug Administration had lifted its compliance warning for its Eatontown facility in New Jersey.
The FDA had issued a warning letter about compliance issues at the facility in February 2012, which led to the company halting production at Eatontown. Hikma took corrective actions in response to the warning, and following a re-inspection in February 2014, the FDA has cleared it.
The Eatontown facility provides oral products for the US market. Hikma said that it was gradually re-introducing products into the market from the facility.
During 2013, the company posted exceptional costs of USD37 million which were largely due to the write downs of inventory and compliance work at the facility.
Hikma reiterated its guidance for its Generics business in 2014, saying it expects it to see revenue of around USD170 million, with an adjusted operating margin of over 25%.
"I am pleased to report that we have brought the Eatontown facility back into compliance with the US FDA," Chief Executive Said Darwazah in a statement. "The investment we have made to complete the re-mediation 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."
Shares in Hikma were trading up 0.4% at 1,681.00 pence Wednesday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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