Drug Master Files for: ticagrelor
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ticagrelor Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 28110 | A | II | 2/20/2014 | PHARMARESOURCES (KAIYUAN) CO LTD | 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:37660 |
| 28111 | A | II | 2/20/2014 | PHARMARESOURCES (KAIYUAN) CO LTD | TICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS: 145783-15-9) |
| 28112 | A | II | 2/20/2014 | PHARMARESOURCES (KAIYUAN) CO LTD | TICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE (R)-2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8) |
| 28446 | A | II | 8/28/2014 | DR REDDYS LABORATORIES LTD | TICAGRELOR |
| 28456 | I | II | 7/1/2014 | PHARMARESOURCES (KAIYUAN) CO LTD | TICAGRELOR (CAS: 274693-27-5) |
| 28674 | A | II | 9/24/2014 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | TICAGRELOR |
| 28787 | A | II | 1/30/2015 | HEC PHARM CO LTD | TICAGRELOR NON-STERILE BULK DRUG SUBSTANCE |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
