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List of Drug Master Files (DMF) of Dronedarone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 502Xls
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01 1ChemWerth Inc

02 1Sanofi

03 1ALP Pharm

04 1Alembic Pharmaceuticals Limited

05 1Alkem Laboratories

06 1Apotex Pharmachem

07 1Aurobindo Pharma Limited

08 1Aurore Life Sciences

09 1Emcure Pharmaceuticals

10 1Glenmark Life Sciences

11 1Lupin Ltd

12 2MSN Laboratories

13 1Piramal Pharma Solutions

14 1Raks Pharma

15 1Sinopep Pharmaceutical Inc

16 1Sun Pharmaceutical Industries Limited

17 1Symed Labs

18 1Unimark Remedies Limited

19 1Viatris

20 2Wisdom Pharmaceutical

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PharmaCompass

01

AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-01

Pay. Date : 2013-05-07

DMF Number : 26479

Submission : 2013-05-02

Status : Active

Type : II

Chemwerth Compnay Banner

02

AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18409

Submission : 2005-06-08

Status : Active

Type : II

Sanofi Company Banner

09

AAPS 2024
Not Confirmed