Drug Master Files for: eliglustat tartrate
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eliglustat tartrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 31475 | A | II | 3/13/2017 | DR REDDYS LABORATORIES LTD | ELIGLUSTAT TARTRATE |
| 32303 | A | II | 12/14/2017 | RAKS PHARMA PVT LTD | ELIGLUSTAT HEMITARTRATE |
| 32537 | A | II | 3/30/2018 | CIPLA LTD | ELIGLUSTAT HEMITARTRATE |
| 32572 | A | II | 3/20/2018 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | ELIGLUSTAT TARTRATE |
| 32612 | A | II | 3/28/2018 | MAITHRI LABORATORIES PRIVATE LTD | ELIGLUSTAT TARTRATE (PREMIX) |
| 32653 | A | II | 3/27/2018 | MAITHRI LABORATORIES PRIVATE LTD | ELIGLUSTAT TARTRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
