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Second Warning Letter Issued to Apotex

Apr 16, 2010 | Parker Waichman LLP

The Food & Drug Administration (FDA) has once again taken generic drug maker Apotex to task for conditions at one of its plants.

Canada-based Apotex was the eighth-largest provider of generics in the U.S. last year, according to the New York Times, quoting industry research firm IMS Health. American sales totaled $879 million last year, with 94 million prescriptions filled with the company’s medicines.

Manufacturing issues at Apotex have caused other problems with U.S. regulators in the past. According to the Times, such issues prompted the firm to recall 659 batches of various drugs in the U.S. between July 2007 to August 2009.

According to The New York Times, an FDA warning letter dated March 29 lists a number of problems at the Apotex plant in Toronto, Canada.  These included charred particles in a diabetes drug; contamination of an antihistamine, and drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment.  The problems were found during an inspection of the facility last summer.

This is the second time in the past year that the FDA has issued Apotex a warning letter over conditions at one of its manufacturing plants, the Times said. This past June, the agency warned the company about similar issues at its Etobicoke, Ontario.

The most recent letter states that Apotex shouldn’t be allowed to win approval for new generic drugs or send products to the U.S. until it corrects “significant violations” of good manufacturing practice at the Toronto facility.

Since last August, neither the Toronto or Etobicoke Apotex facilities have been allowed to ship drugs to the U.S., however other facilities operated by the company can still do so.


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