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List of Drug Master Files (DMF) of MolPort-001-794-643 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 244Xls
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01 2Hubei Gedian Humanwell Pharmaceutical

02 2Pfizer CentreOne

03 2Symbiotec Pharmalab

04 1Aspen API

05 2ACS DOBFAR SPA

06 1Actavis Inc

07 2Catalent Pharma Solutions

08 1F.I.S. Fabbrica Italiana Sintetici

09 1Industriale Chimica

10 1JiangXi Hongyuan Pharmaceutical Material

11 2Jiangsu Jiaerke Pharmaceuticals Group

12 2Laboratorio Syntex S.A

13 1Organon

14 1Productos Quimicos Naturales

15 1Quimica Sintetica

16 1SIGMA TAU

17 1Signa S.A. de C.V.

18 2Zhejiang Shenzhou Pharmaceutical

19 1Zhejiang Xianju Xianming Pharmaceutical

20 2Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2018-10-25

Pay. Date : 2018-07-27

DMF Number : 27668

Submission : 2013-11-01

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

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 : 1418

Submission : 1969-09-04

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 : N/A

Rev. Date :

Pay. Date :

DMF Number : 29030

Submission : 2015-01-20

Status : Active

Type : II

Symbiotec Pharmalab

04

GDUFA

DMF Review : Complete

Rev. Date : 2019-05-14

Pay. Date : 2019-05-09

DMF Number : 3823

Submission : 1980-05-20

Status : Active

Type : II

Aspen API Comapny Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2021-03-11

Pay. Date : 2021-01-12

DMF Number : 33003

Submission : 2018-07-25

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

06

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2019-06-03

Pay. Date : 2018-03-16

DMF Number : 32099

Submission : 2017-12-28

Status : Active

Type : II

Pfizer centreOne

07

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2019-09-11

Pay. Date : 2019-06-10

DMF Number : 32709

Submission : 2018-04-03

Status : Active

Type : II

Symbiotec Pharmalab

08

Boulder Peptide 2024
Not Confirmed

09

Boulder Peptide 2024
Not Confirmed

09

Boulder Peptide 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2019-11-05

Pay. Date : 2019-10-29

DMF Number : 5416

Submission : 1984-06-08

Status : Active

Type : II

blank

10

Boulder Peptide 2024
Not Confirmed

10

Boulder Peptide 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-01-21

Pay. Date : 2015-01-13

DMF Number : 19792

Submission : 2006-09-18

Status : Active

Type : II

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