* Says letter pertains to Milan facility
* Says letter related to collection, maintenance of data * Sees responding to letter in time
Aug 24 (Reuters) - Cambrex Corp CBM.N, an active pharmaceutical ingredient provider, said it received a warning letter from the U.S. health regulator on collection and maintenance of laboratory data at its manufacturing facility in Milan, Italy.
Until the observations made by the FDA are rectified, the agency may withhold approval of any new applications listing the Milan facility as the active ingredient manufacturer, and products manufactured at the site may be denied entry into the United States, Cambrex said in a statement.
Cambrex has already addressed a number of observations and expects to respond to the letter within the time frame set by the FDA, the company said, adding that the observations were related only to its generic active pharmaceutical ingredient manufacturing plant in Milan.
With the current warning letter, Cambrex adds to a string of companies that have come under the U.S. Food and Drug Administration’s scanner, after the agency had cracked down on Caraco Pharmaceutical Laboratories Ltd CPD.A and Canada’s Apotex Inc. Shares of the company closed at $5.37 Monday on the New York Stock Exchange. (Reporting by Vidya L Nathan in Bangalore; Editing by Pradeep Kurup)