Drug Master Files for: sirolimus
✉ Email this page to a colleague
sirolimus Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16890 | A | II | 10/1/2003 | CHEMWERTH INC | SIROLIMUS |
| 19813 | A | II | 9/28/2006 | LONZA AG | SIROLIMUS |
| 21037 | A | II | 11/13/2007 | EUTICALS SPA | Sirolimus |
| 21425 | I | II | 3/8/2008 | WORLD JIANGSU INDUSTRY CO LTD | RAPAMYCIN/SIROLIMUS (NON-STERILE, A INGREDIENT) |
| 21571 | A | II | 4/16/2008 | BIOCON LTD | SIROLIMUS DRUG SUBSTANCE |
| 23109 | I | II | 9/14/2009 | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | SIROLIMUS |
| 24468 | A | II | 2/24/2011 | CONCORD BIOTECH LTD | SIROLIMUS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
