Drug Master Files for: protein
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protein Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10849 | I | II | 4/11/1994 | PIERCE CHEMICAL CO | EMPHAZE PROTEIN A BIOSUPPORT MEDIUM |
| 11363 | I | II | 2/27/1995 | BIOSEPRA INC | PROTEIN A-HYPER D. |
| 12874 | I | II | 2/23/1998 | REPLIGEN CORP | IMMOBILIZED PROTEIN A IPA-400HC |
| 13155 | I | II | 8/26/1998 | REPLIGEN CORP | IMMOBLIZED (R) PROTEIN (A) TM, IPA-500 |
| 14 | I | 6/13/1947 | PROTEIN DIGEST | ||
| 14525 | I | II | 11/12/1999 | SAFC BIOSCIENCES INC | EX-CELL 325 PF CHO PROTEIN FREE MEDIUM |
| 15897 | I | II | 3/14/2002 | SAFC BIOSCIENCES INC | EX-CELL(TM) 325 PF CHO PROTEIN-FREE MEDIUM (MODIFIED) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
