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Harvard Business School

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Drug Master Files for: mirabegron

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mirabegron Drug Master Files

DMF No. Status Type Submission Date Holder Subject
28071 A II 3/20/2014 MSN LABORATORIES PRIVATE LTD MIRABEGRON [ROUTE CODE MG]
28392 A II 6/30/2014 DR REDDYS LABORATORIES LTD MIRABEGRON [PRODUCT CODE: AEB]
28420 A II 6/25/2014 OPTIMUS DRUGS PRIVATE LTD (1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON INTERMEDIATE)
29064 A II 2/27/2015 DR REDDYS LABORATORIES LTD MIRABEGRON [FORM - AMORPHOUS]
29734 A II 9/28/2015 MICRO LABS LTD MIRABEGRON
29773 A II 9/25/2015 MEGAFINE PHARMA P LTD MIRABEGRON DRUG SUBSTANCE
29889 A II 10/6/2015 OPTIMUS DRUGS PRIVATE LTD (R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ETHYL]AMINO]METHYL]BENZENE METHANOL(MIRABEGRON INTERMEDIATE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

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McKinsey
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