Drug Master Files for: LIRAGLUTIDE
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LIRAGLUTIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27215 | A | II | 6/12/2013 | AMBIOPHARM INC | LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE |
| 28513 | I | II | 6/23/2014 | CHENGDU SHENGNUO BIOPHARM CO LTD | LIRAGLUTIDE |
| 29302 | A | II | 10/7/2015 | CHENGDU SHENGNUO BIOPHARM CO LTD | LIRAGLUTIDE |
| 29711 | A | II | 9/10/2015 | ALP PHARM BEIJING CO LTD | LIRAGLUTIDE |
| 30095 | A | II | 12/7/2015 | HYBIO PHARMACEUTICAL CO LTD | LIRAGLUTIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
