Drug Master Files for: PIRFENIDONE
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PIRFENIDONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15168 | A | II | 11/30/2000 | SIGNA SA DE CV | PIRFENIDONE EP |
| 29700 | A | II | 11/4/2015 | HONOUR LAB LTD | PIRFENIDONE |
| 30351 | A | II | 4/13/2016 | LUPIN LTD | PIRFENIDONE |
| 30922 | A | II | 9/30/2016 | GRANULES INDIA LTD | PIRFENIDONE |
| 30952 | A | II | 9/20/2016 | SHILPA MEDICARE LTD | PIRFENIDONE |
| 31072 | A | II | 11/30/2016 | GLENMARK PHARMACEUTICALS LTD | PIRFENIDONE |
| 31264 | A | II | 12/31/2016 | MSN LIFE SCIENCES PRIVATE LTD | PIRFENIDONE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
