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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Teva
QuintilesIMS
Moodys
Harvard Business School

Generated: September 23, 2019

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Drug Master Files for: bendamustine

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bendamustine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
22626 A II 3/13/2009 CHEMPACIFIC CORP BENDAMUSTINE HYDROCHLORIDE
24823 A II 3/30/2011 DR REDDYS LABORATORIES LTD BENDAMUSTINE HYDROCHLORIDE
25222 A II 11/8/2011 SHILPA MEDICARE LTD BENDAMUSTINE HCL
25394 I II 10/18/2011 EUTICALS SPA BENDAMUSTINE HYDROCHLORIDE HYDRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Merck
McKesson
Chubb
Harvard Business School
Queensland Health

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