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By Gil Roth
Published October 9, 2013
End-of-Phase II meeting goes smoothly 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 »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
Published February 13, 2012
No 483 observations issued Read More »
Published November 16, 2011
Also passes sixth product PAI Read More »
Published August 19, 2011
Joint inspection focused on increasing international regulatory collaboration 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 25, 2007
Under legislation to be introduced in the U.S. Senate, makers of generic drugs would gain the right to market generic versions of biopharmaceutical medicines. The legislation would create a pathway for the FDA to approve generic treatments made throu… Read More »
Published January 2, 2007
Ranbaxy Laboratories has received approval from the FDA to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same the… Read More »


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