** Shares in Fagron FAGRO.BR extend losses on Wednesday, a
day after the U.S. health watchdog published a warning regarding
a recent inspection of a repackaging plant in Minnesota - its
second in five years urn:newsml:reuters.com:*:nL8N2YG1PT
** The stock is down nearly 7%, culminating in losses of
over 15% since Tuesday
** The warning addressed failures to properly avoid,
document and resolve potential cross-contamination at the plant,
which repackages pharmaceutical ingredients for Fagron's U.S.
Essential & Brands division
** Analysts say this division accounts for roughly 8-10% of
the group sales, and ING estimates a "somewhat higher percentage
of group EBITDA"
** Fagron has 15 working days from the June 14 warning to
address the unresolved issues, or until the first week of July
** "We emphasise that the FDA warning does not conclude any
product recall, production stop, no lack of assurance of
sterility or determined contamination," says Kempen: "We think
it should not further harm Fagron's reputation"
** ING sees the resulting share drop as "harsh" given lack
of disruption and addressability of the issues, but says this
warning could signal a tougher stance by the FDA to bulk
compounders
(Reporting by Sarah Morland)
((sarah.morland@tr.com
mailto:sarah.morland@thomsonreuters.com))