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

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$ API Ref.Price (USD/KG) : 4,962Xls
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01 2ChemWerth Inc

02 2Biophore India Pharmaceuticals Pvt Ltd

03 1Veranova

04 1Egis Pharmaceuticals PLC

05 1Neuland Laboratories

06 1Emcure Pharmaceuticals

07 1Laboratorio Chimico Internazionale Spa

08 1Sai Life Sciences Limited

09 1Solara Active Pharma Sciences

10 1Sunny Pharmtech

11 1TopChem Pharmaceuticals

12 1Viatris

13 1Zydus Lifesciences

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PharmaCompass

01

  • 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 : 2013-11-27

Pay. Date : 2013-02-06

DMF Number : 26337

Submission : 2013-01-31

Status : Active

Type : II

Chemwerth Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2015-12-17

Pay. Date : 2015-09-08

DMF Number : 29429

Submission : 2015-06-06

Status : Active

Type : II

Biophore

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVeranova: A CDMO that manages complexity with confidence.

GDUFA

DMF Review : Complete

Rev. Date : 2016-08-15

Pay. Date : 2015-09-29

DMF Number : 29781

Submission : 2016-02-18

Status : Active

Type : II

Veranova

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17193

Submission : 2004-02-26

Status : Active

Type : II

Egis Pharmaceuticals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-15

Pay. Date : 2013-09-20

DMF Number : 27473

Submission : 2013-09-03

Status : Active

Type : II

Neuland

06

  • 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 : 2013-07-25

Pay. Date : 2013-02-27

DMF Number : 26338

Submission : 2013-03-01

Status : Active

Type : II

Chemwerth Compnay Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2016-12-23

Pay. Date : 2016-09-21

DMF Number : 30813

Submission : 2016-09-19

Status : Active

Type : II

Biophore

08

Formnext Forum
Not Confirmed

08

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Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-31

Pay. Date : 2013-05-16

DMF Number : 25973

Submission : 2012-04-16

Status : Active

Type : II

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09

Formnext Forum
Not Confirmed

10

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