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

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01 1EUROAPI

02 1Fermion Oy

03 1SCI Pharmtech

04 1Abbott Laboratories

05 2Alkaloida Chemical Company Zrt

06 1Chongqing Kangle Pharmaceutical

07 1Curia

08 1Ipca Laboratories

09 1Laurus Labs

10 1MSN Laboratories

11 1SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD

12 2SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL

13 1SMS Pharmaceuticals

14 1Shanghai Ziyuan Pharmaceutical

15 1Srini Pharmaceuticals

16 1Symed Labs

17 1Unimark Remedies Limited

18 1Wuhan Wuyao Pharmaceutical

19 1Zhejiang Supor Pharmaceuticals Co., LTD

20 1Zhuhai Rundu Pharmaceutical

21 1Zydus Lifesciences

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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 : 2022-02-16

Pay. Date : 2022-02-11

DMF Number : 20692

Submission : 2007-07-17

Status : Active

Type : II

EUROAPI Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-26

Pay. Date : 2016-01-21

DMF Number : 30014

Submission : 2015-11-24

Status : Active

Type : II

fermion

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-11

Pay. Date : 2015-09-08

DMF Number : 8619

Submission : 1990-06-27

Status : Active

Type : II

SCI Company Banner

04

Discovery on Target
Not Confirmed

04

Discovery on Target
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2018-05-11

Pay. Date : 2018-04-04

DMF Number : 23582

Submission : 2010-03-25

Status : Active

Type : II

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05

Discovery on Target
Not Confirmed

08

Discovery on Target
Not Confirmed