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Hikma Pharma says US FDA issues warning on Portugal plant

Reuters - UK Focus

Oct 24 (Reuters) - Drugmaker Hikma Pharmaceuticals Plc said the U.S. Food and Drug Administration had raised issues related to investigations and environmental monitoring at its plant in Portugal.

The Jordanian company said it had received a warning letter from FDA on Thursday following an inspection of the plant in March. Hikma produces powder, liquid and lyophilised injectible drugs at the plant.

Hikma, which makes and markets branded and non-branded generics and injectibles, said it would work with the FDA to resolve all outstanding issues and did not anticipate any impact on manufacturing or distribution of products from the plant.

The company added that it did not believe the warning would impact its financial guidance for the year. (Reporting by Roshni Menon in Bangalore; Editing by Gopakumar Warrier)