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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FDA revises draft guidance document to address industry comments Read More »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 June 25, 2012
First U.S.-based packaging facility to handle CV, metabolic drugs 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 September 13, 2011
Facility is fully validated for manufacture of injectable sterile products 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 »
Published June 28, 2007
SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing… Read More »
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