Drug Master Files for: carfilzomib
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carfilzomib Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 29671 | A | II | 8/29/2015 | MSN LABORATORIES PRIVATE LTD | CARFILZOMIB [ROUTE CODE CJ] |
| 29750 | A | II | 1/30/2016 | FRESENIUS KABI ONCOLOGY LTD | CARFILZOMIB |
| 29770 | A | II | 9/28/2015 | QILU PHARMACEUTICAL CO LTD | CARFILZOMIB (NON-STERILE, API) |
| 30115 | A | II | 3/22/2016 | LAURUS LABS LTD | CARFILZOMIB |
| 30124 | A | II | 1/21/2016 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CARFILZOMIB |
| 30162 | I | II | 12/29/2015 | CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTD | CARFILZOMIB (NON-STERILE BULK DRUG SUBSTANCE) |
| 30357 | A | II | 2/26/2016 | POLYMED THERAPEUTICS INC | CARFILZOMIB 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
