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Serving leading biopharmaceutical companies globally:

US Army
Merck
Covington
Cantor Fitzgerald
Chinese Patent Office
Argus Health
UBS
Mallinckrodt
Johnson and Johnson
Fish and Richardson

Generated: December 10, 2017

DrugPatentWatch Database Preview

Drug Master Files for: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

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DMF No. Status Type Submission Date Holder Subject
15127III11/2/2000ESTEVE QUIMICA SAAMLODIPINE BESILATE
15746III12/3/2001DR REDDYS LABORATORIES LTDAMLODIPINE MALEATE
15777AII12/21/2001TEVA PHARMACEUTICAL INDUSTRIES LTDAMLODIPINE BESYLATE
16473AII3/19/2003DR REDDYS LABORATORIES LTDAMLODIPINE BESILATE USP
16478III3/18/2003HETERO DRUGS LTDAMLODIPINE BESILATE
16509AII4/1/2003UNICHEM LABORATORIES LTDAMLODIPINE BESILATE USP
16552III4/28/2003MATRIX LABORATORIES LTDAMLODIPINE MESYLATE
16596III5/19/2003MATRIX LABORATORIES LTDAMLODIPINE
16887III10/2/2003LEK PHARMACEUTICALS DDAMLODIPINE BESYLATE
16911AII9/13/2003CADILA PHARMACEUTICALS LTDAMLODIPINE BESYLATE USP
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Teva
Chubb
QuintilesIMS
Moodys
Queensland Health
Chinese Patent Office
McKesson
Accenture
Johnson and Johnson
Julphar

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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