Drug Master Files for: Gruppo Lepetit
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Gruppo Lepetit Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
3103 | I | II | 1/13/1977 | GRUPPO LEPETIT SPA | L-ALANOSINE |
4768 | I | II | 12/16/1982 | GRUPPO LEPETIT SPA | TERFENADINE |
8190 | I | I | 8/31/1989 | GRUPPO LEPETIT SPA | FACILITIES LOCATED IN GARESSIO (CUNEO) ITALY |
8982 | I | I | 2/18/1991 | GRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INC | FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY |
9252 | I | I | 7/19/1991 | GRUPPO LEPETIT SPA | FACILITIES AND PROCEDURES IN GERENZANO (VARESE), ITALY |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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