Drug Master Files for: MICAFUNGIN SODIUM
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MICAFUNGIN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27435 | A | II | 9/25/2013 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | MICAFUNGIN SODIUM |
| 29662 | A | II | 9/29/2015 | SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTD | MICAFUNGIN SODIUM |
| 30028 | A | II | 11/11/2015 | BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD | MICAFUNGIN SODIUM INTERMEDIATE A |
| 30558 | A | II | 6/6/2016 | MEDICHEM MANUFACTURING MALTA LTD | MICAFUNGIN SODIUM |
| 30880 | A | II | 9/30/2016 | BIOCON LTD | MICAFUNGIN SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
