Drug Master Files for: Gland Pharma Ltd
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Gland Pharma Ltd Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14613 | I | V | 11/30/1999 | GLAND PHARMA LTD | STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN AMEEPET AND DUNDIGAL, INDIA |
| 20833 | A | II | 9/5/2007 | GLAND PHARMA LTD | ROCURONIUM BROMIDE USP |
| 21189 | A | II | 12/3/2007 | GLAND PHARMA LTD | ATRACURIUM BESYLATE USP |
| 22962 | A | II | 7/21/2009 | GLAND PHARMA LTD | CISATRACURIUM BESYLATE |
| 23172 | A | II | 9/22/2009 | GLAND PHARMA LTD | DEXRAZOXANE |
| 23173 | A | II | 10/7/2009 | GLAND PHARMA LTD | TIROFIBAN HYDROCHLORIDE |
| 23232 | A | II | 10/30/2009 | GLAND PHARMA LTD | DEXMEDETOMIDINE HYDROCHLORIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
