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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving 500+ biopharmaceutical companies globally:

Moodys
Novartis
US Army
McKinsey
Teva
Harvard Business School
Medtronic
Covington
Boehringer Ingelheim
McKesson

Generated: September 20, 2017

DrugPatentWatch Database Preview

Drug Master Files for: Amgen

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DMF No. Status Type Submission Date Holder Subject
18672III4/2/2001AMGEN INCHUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15
21000AV11/12/2007AMGEN INCAML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES
22171IV11/11/2008AMGEN INCPRODUCTION MODULE 2 (PM2) ASEPTIC FACILITY LOCATED CO. DUBLIN, IRELAND
29873AII11/6/2015AMGEN INCAMG 191 DRUG SUBSTANCE
29877AII11/6/2015AMGEN INCAMG 191 CELL LINE DEVELOPMENT
29883AII11/6/2015AMGEN INCAMG 191 DRUG PRODUCT
30198AII2/22/2016AMGEN INCAMG 282 DRUG SUBSTANCE
31396AII4/20/2017AMGEN INCINTRAVENOUS SOLUTION STABILIZER (IVSS)
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Cerilliant
US Department of Justice
Federal Trade Commission
Queensland Health
Chubb
Argus Health
Farmers Insurance
QuintilesIMS

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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