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Harvard Business School
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Generated: May 21, 2019

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Drug Master Files for: levocetirizine

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levocetirizine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20173 A II 1/17/2007 CIPLA LTD LEVOCETIRIZINE DIHYDROCHLORIDE USP
21005 A II 11/2/2007 DR REDDYS LABORATORIES LTD LEVOCETIRIZINE DIHYDROCLORIDE USP
21110 A II 12/6/2007 GLOCHEM INDUSTRIES PRIVATE LTD LEVOCETIRIZINE DIHYDROCHLORIDE USP
21214 A II 1/4/2008 SUN PHARMACEUTICAL INDUSTRIES LTD Levocetirizine Dihydrochloride
21417 A II 3/11/2008 RA CHEM PHARMA LTD LEVOCETIRIZINE DIHYDROCHLORIDE USP
22286 A II 12/15/2008 SYMED LABS LTD LEVOCETIRIZINE DIHYDROCHLORIDE
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 hundreds of leading biopharmaceutical companies globally:

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Covington
Julphar
AstraZeneca

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