1 2 3 4 5

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
  Hyperuricemia treatment drugs 10\20 and 40 mg Teijin
  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