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

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Pharmaceutical Technology, Pharmaceutical Technology-03-15-2016, Volume 2016 eBook, Issue 1
Pages: s46-s54

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

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

from Pharmaceutical Technology’s 2016 Solid Dosage Drug Development and Manufacturing eBook.

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