Drug Master Files for: PLERIXAFOR
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PLERIXAFOR Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
26444 | A | II | 11/1/2012 | DR REDDYS LABORATORIES LTD | PLERIXAFOR |
26603 | A | II | 11/12/2012 | HETERO LABS LTD | PLERIXAFOR |
29507 | A | II | 7/4/2015 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | PLERIXAFOR |
30877 | A | II | 9/6/2016 | MSN LABORATORIES PRIVATE LTD | PLERIXAFOR |
31572 | A | II | 4/26/2017 | GLAND PHARMA LTD | PLERIXAFOR |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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