ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 15, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 15, 2011
News
FDA–EMA Joint Manufacturing Inspections to Begin in 2012
By Rich Whitworth
The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer.
FDA Warns Novartis of Violations at Three Plants
By Erik Greb
In a Warning Letter, FDA cited "significant violations" of CGMP regulations, including several repeat observations, at three Novartis facilities located in Colorado, North Carolina, and Canada.
AstraZeneca to Expand Presence in China
By Amy Ritter
AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in China, for an undisclosed amount. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines.
EMA Addresses Ben Venue Quality Issues
By Stephanie Sutton
After reviewing the "shortcomings in quality assurance" that were recently identified at Ben Venue Laboratories's Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta and Liminity.
Week of Dec. 12, 2011: Baxter International Agrees to Acquire Synovis Life Technologies; Pfizer Elects President and CEO Ian Read as Chairman of Board of Directors; and More
Baxter International Agrees to Acquire Synovis Life Technologies; Pfizer Elects President and CEO Ian Read as Chairman of Board of Directors; and More.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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