ePT--the Electronic Newsletter of Pharmaceutical Technology, Jan 17, 2013 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jan 17, 2013
Hameln Pharmaceuticals Receives FDA Warning Letter
By Stephanie Sutton
FDA has issued a Warning Letter to Hameln Pharmaceuticals GmbH after observing "significant" cGMP violations for finished pharmaceuticals at the company?s facility in Hameln, Germany.
Lonza Expands Antibody-Drug Conjugate Manufacturing Capacity
By Amy Ritter
Lonza will invest CHF 14 million ($15.1 million) to double the existing large-scale manufacturing capacity in Visp, Switzerland.
FDA Releases Guidance on Opioids
By Susan Haigney
FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance
EMA Updates Guideline for Anticancer Medicines
By Stephanie Sutton
The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products.
Industry Briefs: January 14, 2013
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.


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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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