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Products
Commercial products
Commercial products
Products under development
Products under development
Early R&D
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CMO/CDMO
CMO/CDMO
Service
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Facility
Featured Products
Featured Products
Commercial products
Products under development
Building Block
Preparations
Preparations
Importing procedures for oversea API
API and formulation for domestic submission
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Preparations
Importing procedures for oversea API
Importing procedures for oversea API
Process and Dossier Requirements for API Registration in P.R. China
1、Original Submissions (restriction part of DMF) provided by SPONSOR
2、Original Submissions translated to Chinese by RA
3、Preliminary review of dossier by RA
Ø Gap Analysis
Ø Additional information required
4、Data and/or experiments supplement
5、Submission to SDA
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