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
News
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FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance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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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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