.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Novartis
Accenture
McKinsey
Cipla
Cantor Fitzgerald
Johnson and Johnson
McKesson
AstraZeneca
US Army
Teva

Generated: February 23, 2018

DrugPatentWatch Database Preview

Drug Master Files for: enzalutamide

« Back to Dashboard


DMF No. Status Type Submission Date Holder Subject
29062AII3/23/2015SAI LIFE SCIENCES LTD4-((2-CYANOPROPAN-2-YL)AMINO)-2-FLUORO-N-METHYLBENZAMIDE (ENZALUTAMIDE INTERMEDIATE)
29117AII3/31/2015DR REDDYS LABORATORIES LTDENZALUTAMIDE
30010AII11/28/2015MYLAN LABORATORIES LTDENZALUTAMIDE
30260AII3/17/2016SHILPA MEDICARE LTDENZALUTAMIDE
30279AII2/29/2016MSN LABORATORIES PRIVATE LTDENZALUTAMIDE [ROUTE CODE EI]
30304AII3/29/2016CADILA HEALTHCARE LTDENZALUTAMIDE
29872AII5/24/2016TEVA PHARMACEUTICAL INDUSTRIES LTDENZALUTAMIDE
30644AII7/9/2016SCINOPHARM TAIWAN LTDENZALUTAMIDE
31196AII12/30/2016LAURUS LABS LTDENZALUTAMIDE
This preview shows a limited number of results
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.


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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
US Department of Justice
Farmers Insurance
Johnson and Johnson
Daiichi Sankyo
Covington
McKinsey
Queensland Health
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2018 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot