Drug Master Files for: doripenem
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doripenem Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25239 | I | II | 11/7/2011 | HOSPIRA HEALTHCARE INDIA PVT LTD | DORIPENEM (STERILE) |
| 25372 | I | II | 10/10/2011 | SANDOZ PRIVATE LTD | DORIPENEM MONOHYDRATE, STERILE |
| 28210 | A | II | 4/25/2014 | UNIMARK REMEDIES LTD | DORIPENEM CRUDE (INTERMEDIATE) |
| 28212 | I | II | 5/3/2014 | AURONEXT PHARMA PRIVATE LTD | DORIPENEM MONOHYDRATE (STERILE) |
| 28280 | A | II | 5/30/2014 | UNIMARK REMEDIES LTD | DORIPENEM STERILE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
