Deborah F. Johnson

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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

David J. Skanchy;Kandasamy Subburaj;Srinivasa Murthy;Humcha Hariprakasha;Brian T. Connell;Huyi Zhang;Deborah F. Johnson

March 15th 2016

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

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