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Products
Commercial products
Commercial products
Products under development
Products under development
Early R&D
Advanced stage product
Building Block
Building Block
CMO/CDMO
CMO/CDMO
Service
Reaction
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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Products
Preparations
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
API and formulation for domestic submission
API
Application and Background
Sitagliptin phosphate
DPP-IV Best sell diabetes drug 25 mg and 100 mg MSD
Febuxostat
Hyperuricemia treatment drugs 10\20 and 40 mg Teijin
Lenvatinib
Liver cancer 4 mg and 10 mg Eisai
Bisoprolol fumarate
Antihypertensive 2.5 mg and 5 mg Merck Serono
Sodium Picosulfate
Constipation and Large bowel before colonoscopy or surgery 10gm Ferring Pharm Inc
1. Marketing Authorization Holder
Looking for OEM site for API and formulation
2. API and Formulation Tech Transfer
Milestone Payment
3. Project joint-venture
Joint investment and Share profits
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