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High Potency Regulations
By Stephanie Wilkins, PharmaConsult US, Inc.
Published November 13, 2013
Uncertainty remains in the quest to define certain products Read More »
Published June 26, 2013
Wolfratshausen facility supports dosage forms for U.S. distribution Read More »
Critical Design Strategies for Extractables and Leachables Control
By Thomas Feinberg, Catalent Pharma Solutions
Published April 3, 2013
Methods for avoiding contamination Read More »
By Gil Roth
Published March 25, 2013
PAI waived, Cook Pharmica to help reduce drug shortage Read More »
By Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
Published January 22, 2013
FDA revises draft guidance document to address industry comments Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
By Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
Published March 7, 2012
New guidance seeks to clear up manufacturer communications Read More »
Published October 6, 2011
Vadodara site can now provide API manufacturing Read More »
Published June 15, 2011
Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA. Read More »
By Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »
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