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Generic Drug, API & DMF

GMP, DMF, active pharmaceutical ingredients (APIs), ドラッグマスターファイル,原薬 原料藥, generic drug, 學名藥, 仿制藥, biogeneric drug

2006/7/12

The Battle for IP (2003)

http://www.ropesgray.com/files/tbl_s18CaseStudies%5CPDFUpload187%5C26%5CWindhover%20June%202003%20G.%20Glover.pdf
Patent certification options
Brand vs first ANDA filer Activity Summary
NDA Patent and Data Exclusivity
Multiple ANDAs http://www.fda.gov/CDER/GUIDANCE/5710fnl.pdf
Post by: Unknown On 7/12/2006
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Tag: patent, regulation

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