Neeru Takiar

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Neeru Takiar is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFs

David J. Skanchy;Huyi Zhang;Jizhou Wang;Neeru Takiar
February 2nd 2017

Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

Jizhou Wang;Neeru Takiar;Huyi Zhang;David J. Skanchy
February 2nd 2017

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

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