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 The Jordanian company said it had received a warning letter from the
U.S. Food and Drug Administration on Thursday following an
inspection of the plant in March.
Shares in the company, which makes and markets branded and
non-branded generics and injectibles, fell 3.5 percent in early
trading on the London Stock Exchange on Friday.
Hikma produces powder, liquid and lyophilized injectible drugs at
the Portugal plant. The injectibles business accounted for 39
percent of the company's revenue in 2013.
Hikma 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 also said that it did not believe the warning would
impact its financial guidance for the year.
"The fact that it took seven months for the FDA to issue this
warning letter ... suggests that the FDA does not consider this
issue as posing an immediate threat to public health and is
therefore unlikely to request the plant to be closed," UBS analysts
wrote in a note.
Hikma had received an FDA warning letter on its Eatontown facility
in New Jersey in February 2012 and suspended manufacturing at the
plant.
The facility underwent extensive remediation work last year before
receiving the go-ahead to restart operations in April.
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"Although on the face of it this letter is not a particular worry,
it will remind investors that pharmaceutical manufacturing is not
without risk and in fact Hikma itself has benefited in recent years
from manufacturing constraints of competitor Hospira Inc," Panmure
Gordon analyst Savvas Neophytou said in a note to clients.
Hikma shares were down 3.2 percent at 1839 pence at 0729 GMT.
(Reporting by Roshni Menon in Bangalore; Editing by Gopakumar
Warrier)
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