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

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$ API Ref.Price (USD/KG) : 698Xls
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01 2EUROAPI

02 3Pfizer CentreOne

03 1Symbiotec Pharmalab

04 1Axplora

05 1ACS DOBFAR SPA

06 2Cyclo Industries

07 2Fujifilm Diosynth Biotechnologies

08 1Mahima Life Sciences

09 5Merck & Co

10 1Quimica Sintetica

11 1SIMS Srl

12 1Shandong Sito Bio-technology Co ltd

13 2Tianjin Tianyao Pharmaceuticals Co., Ltd.

14 1Xi'an Guokang Ruijin Pharmaceutical

15 1Yangzhou Pharmaceutical

16 1Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-28

Pay. Date : 2013-09-18

DMF Number : 1748

Submission : 1971-06-21

Status : Active

Type : II

EUROAPI Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-06

Pay. Date : 2013-02-14

DMF Number : 4524

Submission : 1982-05-10

Status : Active

Type : II

Pfizer centreOne

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2023-10-26

Pay. Date : 2023-10-03

DMF Number : 38162

Submission : 2023-03-29

Status : Active

Type : II

Symbiotec Pharmalab

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2019-04-09

Pay. Date : 2018-03-15

DMF Number : 31532

Submission : 2017-03-10

Status : Active

Type : II

Axplora CB

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2736

Submission : 1976-07-19

Status : Active

Type : II

EUROAPI Compnay Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12127

Submission : 1996-09-11

Status : Active

Type : II

Pfizer centreOne

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4532

Submission : 1982-05-10

Status : Active

Type : II

Pfizer centreOne

08

BioProcess International
Not Confirmed

09

BioProcess International
Not Confirmed

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