DOW JONES NEWSWIRES
Cambrex Corp. (CBM) has received a warning letter from the U.S.
Food and Drug Administration related to a March inspection of the
company's generic active pharmaceutical ingredient, or API,
manufacturing facility in Milan, Italy.
Some of the problems cited in the FDA's letter have already been
addressed, the company said. But the FDA could block U.S. entry for
products manufactured there. It also could withhold approval of new
applications or supplements from the facility.
Cambrex added that it expects to address all of the issues in
the time period prescribed by the FDA. The letter only applies to
the Milan facility, and is not related to other manufacturing
facilities.
The company last month reported second-quarter sales fell 9.8%
on currency changes, but earnings tripled on cost cuts.
Shares recently fell nearly 1% to $5.31.
-By Alexandra Scaggs, Dow Jones Newswires; 212-416-2673;
alexandra.scaggs@dowjones.com
