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Last Updated: December 7, 2021

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Drug Master Files for: ropivacaine hydrochloride


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ropivacaine hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18288 A II 4/15/2005 EXCELLA GMBH AND CO KG ROPIVACAINE HYDROCHLORIDE
19084 A II 12/30/2005 NAVINTA LLC ROPIVACAINE
20249 A II 2/2/2007 CHEMWERTH INC ROPIVACAINE HCL MONOHYDRATE
20654 A II 7/3/2007 FINE CHEMICALS CORP PTY LTD ROPIVACAINE HYDROCHLORIDE
22023 A II 9/22/2008 DISHMAN CARBOGEN AMCIS LTD ROPIVACAINE HYDROCHLORIDE ANHYDROUS
23239 A II 11/2/2009 FINE CHEMICALS CORP PTY LTD ROPIVACAINE
24948 A II 10/12/2011 JUBILANT GENERICS LTD ROPIVACAINE HYDROCHLORIDE USP
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Mallinckrodt
Medtronic
AstraZeneca
Moodys
Dow
McKinsey

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