Drug Master Files for: Haupt Pharma
✉ Email this page to a colleague
Haupt Pharma Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14172 | I | II | 5/31/1999 | HAUPT PHARMA GMBH | L-CARNITINE CAPSULES 500MG |
22759 | A | V | 4/24/2009 | HAUPT PHARMA LATINA SRL | STERILE PEN POWDERS ASEPTIC FACILITY |
25599 | A | V | 12/16/2011 | HAUPT PHARMA WOLFRATSHAUSEN GMBH | ASEPTIC PROCESS VALIDATION |
28331 | A | V | 5/23/2014 | HAUPT PHARMA WOLFRATSHAUSEN GMBH | STERILE DEPARTMENT 2, ASEPTIC PROCESS VALIDATION OF CYTOTOXIC PRODUCTS |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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