Drug Master Files for: GLATIRAMER ACETATE
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GLATIRAMER ACETATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
25855 | A | II | 3/24/2012 | DR REDDYS LABORATORIES LTD | GLATIRAMER ACETATE |
26489 | A | II | 9/27/2012 | AMBIOPHARM INC | GLATIRAMER NON-STERILE, BULK DRUG SUBSTANCE |
27723 | A | II | 12/12/2013 | CORDEN PHARMA COLORADO INC | GLATIRAMER ACETATE |
28989 | A | II | 12/25/2014 | HYBIO PHARMACEUTICAL CO LTD | GLATIRAMER ACETATE, NON-STERILE BULK DRUG SUBSTANCE |
33092 | A | II | 9/12/2018 | GLAND PHARMA LTD | GLATIRAMER ACETATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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