ePT--the Electronic Newsletter of Pharmaceutical Technology
CEPH International Replies to FDA Warning Letter
Patheon Inc. (Mississauga, ON, Canada) announced this morning that its CEPH International subsidiary has filed a response to the US Food and Drug Administration’s Sept. 16 warning letter (see last week’s ePT).
After receiving the warning, CEPH suspended production of the oral suspension versions of the “Omnicef” powder products. The company reports that “CEPH, with the assistance of experts from Patheon, its client, and external consultants, worked diligently to analyze the issues raised by the FDA and to develop an enhanced process-improvement program to address the FDA's concerns. CEPH is currently implementing process improvements consistent with the program outlined in the response letter to the FDA.”
The company said that it anticipates resuming normal production in the first quarter of 2006, though the actual timing depends on the FDA’s response.
–Douglas McCormick
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.