Hikma Pharmaceuticals Falls On FDA Warning For Portugal Plant

Published: Oct 24, 2014

Hikma Pharmaceuticals Falls On FDA Warning For Portugal Plant

October 24, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Hikma Pharmaceuticals said today that the U.S. Food and Drug Administration has issued a warning for its manufacturing plant in Portugal, directly on the heels of American regulators voiced their concerns about environmental monitoring at the same facility, according to Proactive Investors.

Hikma said it is working with the FDA to resolve all of the outstanding issues that have been cited thus far.

“At this point, Hikma does not anticipate that the warning letter will impact the manufacturing or distribution of the products manufactured in its Portugal facility, and does not believe that it will impact its financial guidance for 2014,” the company stated in a release.

The company has facilities located in 11 countries and 27 manufacturing facilities around the world. It said it will provide further updates on this development as they arrive.

The Growth of Hikma Pharmaceuticals
On Sept. 17, Hikma announced that it had completed its acquisition of the genetic injectable manufacturing site previously owned by Ben Venue Laboratories, Inc. The agreement was officially signed on July 24, but the full acquisition has just been completed.

The Ben Venue site includes four manufacturing plants and a Quality and Development Center, which includes a research and development pilot plant. This will strengthen Hikma’s existing research and development capabilities and support the development of its pipeline. Hikma also intends to transfer certain modern equipment to the area to increase capacity at other plants located in the U.S. and Europe.

"I am very pleased to be acquiring the Ben Venue manufacturing site, which will significantly enhance our R&D capabilities and enable us to expand future capacity,” stated Said Darwazah, chairman and chief executive officer of Hikma. “This reflects our commitment to the long term growth of our global Injectables business and will create significant strategic value."

Hikma focuses on developing, manufacturing and marketing a broad range of branded and non-branded generic and in-licensed products. Hikma operates primarily in the Middle East and North Africa where it is a market leader, in addition to the U.S. and Europe. It had profit attributable to shareholders of $212 million as of 2013.

Back to news