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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 leading biopharmaceutical companies globally:

Moodys
Baxter
Healthtrust
Colorcon
Federal Trade Commission
Merck
Julphar
Mallinckrodt
UBS
Chinese Patent Office

Generated: December 17, 2017

DrugPatentWatch Database Preview

Drug Master Files for: risperidone

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DMF No. Status Type Submission Date Holder Subject
11438AII4/11/1995JANSSEN PHARMACEUTICA NVRISPERIDONE DRUG SUBSTANCE
15604AII8/29/2001TEVA PHARMACEUTICAL INDUSTRIES LTDRISPERIDONE USP
15682AII10/23/2001INKE SARISPERIDONE
16023III6/20/2002DR REDDYS LABORATORIES LTDRISPERIDONE EP
16516III4/1/2003MEDICHEM SARISPERIDONE
16517AII4/8/2003JUBILANT GENERICS LTDRISPERIDONE-USP
16902AII10/10/2003DR REDDYS LABORATORIES LTDRISPERIDONE FORM-1 USP
16963AII11/17/2003CIPLA LTDRISPERIDONE USP
16978AII11/19/2003CATALENT PHARMA SOLUTIONS LLCRISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS
17260III3/24/2004CATALENT PHARMA SOLUTIONS LLCRISPERIDONE 2.0 MG ORALLY DISINTEGRATING TABLETS
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Express Scripts
Argus Health
Cipla
McKesson
Chinese Patent Office
Queensland Health
Novartis
Baxter
Fuji
Fish and Richardson

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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