Hikma Pharmaceuticals, reports that it has received a letter from the US Food and Drug Administration closing out the Warning Letter it received in October 2014 with respect of its injectables manufacturing plant in Portugal. This letter demonstrates that the corrective actions that were taken in response to the Warning Letter were fully reviewed and accepted by the FDA.

Hikma received the FDA Warning Letter on October 23, 2014 related to the agency’s inspection of the company’s manufacturing facility in Portugal in March 2014. The agency raised issues related to investigations and environmental monitoring at the facility.

In 2014, Hikma added to its sterile injectable product portfolio and manufacturing capabilities by acquiring Bedford Laboratories, the US generic injectables business of Ben Venue Laboratories, Inc., and later the Ben Venue manufacturing facility in Bedford, Ohio from Boehringer Ingelheim.

Earlier this year, Hikma Pharmaceuticals agreed to acquire the generics businesses of Boehringer Ingelheim (BI), Roxane Laboratories Inc. and Boehringer Ingelheim Roxane Inc., for $2.65 billion in a cash-and-stock deal,

Hiikma is focused on developing, manufacturing and marketing branded and non-branded generic and in-licensed products. Hikma operates through three businesses: injectables, branded, and generics”, based principally in the United States, the Middle East and North Africa, and Europe.

Source: Hikma Pharmaceuticals