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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Cipla
Express Scripts
Merck
AstraZeneca
US Department of Justice
Johnson and Johnson
Covington
Chubb

Generated: October 23, 2017

DrugPatentWatch Database Preview

Drug Master Files for: valacyclovir

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DMF No. Status Type Submission Date Holder Subject
16300AII12/11/2002SUN PHARMACEUTICAL INDUSTRIES LTDVALACYCLOVIR HYDROCHLORIDE USP (HYDROUS)
17223AII3/10/2003CIPLA LTDVALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP
17794AII10/25/2004TEVA PHARMACEUTICAL INDUSTRIES LTDVALACYCLOVIR HYDROCHLORIDE
17943AII12/29/2004MYLAN LABORATORIES LTDVALACYCLOVIR HYDROCHLORIDE USP
28969AII4/2/2015SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDVALACYCLOVIR HYDROCHLORIDE
18940III10/25/2005OLON SPAVALACYCLOVIR HYDROCHLORIDE MONOHYDRATE
20278III2/9/2007EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET ASVALACYCLOVIR HCI MONOHYDRATE
20454AII4/16/2007LUPIN LTDVALACYCLOVIR HYDROCHLORIDE
20982III10/29/2007DR REDDYS LABORATORIES LTDVALACYCLOVIR HYDROCHLORIDE
21010AII10/26/2007WOCKHARDT LTDValacyclovir Hydrochloride
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKesson
Cipla
Harvard Business School
Deloitte
Merck
Cerilliant
QuintilesIMS
Moodys
Chubb
Covington

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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