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Last Updated: July 28, 2021

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Drug Master Files for: TOPOTECAN HYDROCHLORIDE


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TOPOTECAN HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
19834 I II 10/4/2006 DR REDDYS LABORATORIES LTD TOPOTECAN HYDROCHLORIDE
20723 I II 6/20/2007 SAI PHYTOCEUTICALS PVT LTD TOPOTECAN HYDROCHLORIDE
20810 A II 8/22/2007 SCINOPHARM TAIWAN LTD TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE
21621 A II 7/17/2008 CIPLA LTD TOPOTECAN HYDROCHLORIDE
22303 I II 1/6/2009 FRESENIUS KABI ONCOLOGY LTD TOPOTECAN HYDROCHLORIDE
22859 A II 6/30/2010 CHEMWERTH INC TOPOTECAN HCL
23443 A II 1/11/2010 EMCURE PHARMACEUTICALS LTD TOPOTECAN HYDROCHLORIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Johnson and Johnson
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Express Scripts
Medtronic

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