CEPH International files response to FDA Warning Letter

Published: 17-Oct-2005

CEPH International Corporation, a US-based subsidiary of Patheon Inc, has responded to the US Food & Drug Administration's (FDA) Warning Letter, received in September, and is currently implementing process improvements.


CEPH International Corporation, a US-based subsidiary of Patheon Inc, has responded to the US Food & Drug Administration's (FDA) Warning Letter, received in September, and is currently implementing process improvements.

CEPH suspended production of Omnicef powder for oral suspension product after receiving the FDA's letter and has developed a programme of process improvements to address the FDA's concerns.

Although the copany anticipates that it will re-commence normal production of the Omnicef in the first quarter of its 2006 fiscal year, the actual timing will be dependent on the FDA's response to CEPH's letter.

The company's financial results for the fourth quarter ending October 31, 2005 are expected to drop by around three cents per share as a result of both the decision and the additional costs incurred to address the matter.

  

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