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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Johnson and Johnson
Julphar
Accenture
AstraZeneca
Deloitte
Citi
UBS
Fuji

Generated: January 24, 2018

DrugPatentWatch Database Preview

Drug Master Files for: irinotecan

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DMF No. Status Type Submission Date Holder Subject
17312AII4/20/2004SCINOPHARM TAIWAN LTDIRINOTECAN HYDROCHLORIDE
17348III5/13/2004CHEMWERTH INCIRINOTECAN HCL (NON-STERILE BULK DRUG SUBSTANCE)
17456AII6/8/2004CIPLA LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE USP
18818AII9/23/2005FRESENIUS KABI ONCOLOGY LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE
18891AII10/20/2005YAKULT HONSHA CO LTDTOTAL SYNTHESIS OF TSN-38B-11 INTERMEDIATE COMPOUND USED IN THE MANUFACTURE OF IRINOTECAN HYDROCHLORIDE TRIHYRATE (CPT-11) DRUG SUBSTANCE
18969III10/30/2005POLYMED THERAPEUTICS INCIRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE
19050AII12/20/2005PLIVA-LACHEMA ASIRINOTECAN HYDROCHLORIDE TRIHYDRATE
19222III3/6/2006TERUMO CORPIHL- 305 IRINOTECAN LIPOSOME INJECTION
19661III7/27/2006SAI PHYTOCEUTICALS PVT LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE
20195III1/12/2007SUN PHARMACEUTICAL INDUSTRIES LTDIRINOTECAN HYDROCHLORIDE TRIHYDRATE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Colorcon
Johnson and Johnson
QuintilesIMS
Cipla
Deloitte
Federal Trade Commission
Argus Health
Farmers Insurance
UBS
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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