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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Kaiyuan Hengtai Pharma Co., Ltd. to the U.S. FDA. Original Data : FDA Website

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01 (2S,5R)-5-METHYL-2-(PROPAN-2-YL)CYCLOHEXYL(2R,5S)-5-(4-AMINO-2-OXO-1,2-DIHYDROPYRIMIDIN-1-YL)-1,3-OXATHIOLANE-2-CARBOXYLATE (1)

02 TICAGRELOR (CAS: 274693-27-5) (1)

03 TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE (R)-2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8) (1)

04 TICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R, 6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO-3AH-CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY) ETHANOL L-TARTARIC ACID (1:1) (CAS:376608-65-0) (1)

05 TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS: 145783-15-9) (1)

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01 KAIYUAN BIOPHARMA CO LTD (1)

02 PHARMARESOURCES (KAIYUAN) CO LTD (4)

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01 Blank (5)

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2014-07-01
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2014-02-20
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2018-07-16
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