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Last Updated: July 12, 2020

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Drug Master Files for: Lupin


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Lupin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11291 A II 1/9/1995 LUPIN LTD RIFAMYCIN-S (BULK SUBSTANCE)
11299 I II 1/9/1995 LUPIN CHEMICALS LTD MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TARAPUR, INDIA.
12086 A II 8/2/1996 LUPIN LTD 7-ACCA
13214 A II 4/30/1998 LUPIN LTD RIFAMPIN USP
13217 I II 4/30/1998 LUPIN LTD CEFACLOR USP AS MAUFACTURED IN MANDIDEEP, INDIA
13219 A II 4/30/1998 LUPIN LTD STERILE CEFOTAXIME SODIUM USP
13752 I II 9/1/1998 LUPIN LAB LTD CEPHALEXIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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