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

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$ API Ref.Price (USD/KG) : 106Xls
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01 2Fermion Oy

02 1Cohance Lifesciences

03 1Dr. Reddy's Laboratories

04 1IOL Chemicals and Pharmaceuticals

05 1Moehs Iberica

06 1Aarti Pharmalabs

07 1Medichem S.A

08 1Megafine Pharma (P) Limited

09 1Alembic Pharmaceuticals Limited

10 2Aurobindo Pharma Limited

11 1Cambrex Corporation

12 1Chemeca Drugs

13 1Cipla

14 1CordenPharma

15 1Dishman Carbogen Amcis

16 1Divis Laboratories

17 2F.I.S. Fabbrica Italiana Sintetici

18 3Hetero Drugs

19 1Hikal

20 2Ind Swift Laboratories Limited

21 1Indoco Remedies Limited

22 1Ipca Laboratories

23 2Jubilant Generics

24 1Lupin Ltd

25 1Macleods Pharmaceuticals Limited

26 1Menadiona

27 1Olon S.p.A

28 1Orchid Pharma

29 1Par Pharmaceutical

30 1Piramal Pharma Solutions

31 1RANBAXY LABORATORIES LIMITED

32 1Raks Pharma

33 1Sun Pharmaceutical Industries Limited

34 1Suzhou no. 4 Pharmaceutical Factory

35 1Teva API

36 1Teva Pharmaceutical Industries

37 1Torrent Pharmaceuticals Limited

38 2UQUIFA

39 2Unichem Laboratories Limited

40 1Vasudha Pharma Chem

41 1Viatris

42 1Wanbury Limited

43 1Zhejiang Apeloa Jiayuan Pharmaceutical

44 1Zhejiang Hisun Pharmaceutical

45 1Zhejiang Huahai Pharmaceutical

46 2Zhejiang Supor Pharmaceuticals Co., LTD

47 1Zydus Lifesciences

48 1Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19160

Submission : 2006-02-02

Status : Active

Type : II

fermion

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2017-12-01

Pay. Date : 2017-10-18

DMF Number : 32085

Submission : 2017-10-03

Status : Active

Type : II

Cohance

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17122

Submission : 2004-01-29

Status : Active

Type : II

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37105

Submission : 2023-03-22

Status : Active

Type : II

IOL Chemicals

05

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

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24541

Submission : 2011-01-07

Status : Active

Type : II

Moehs Iberica

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21336

Submission : 2008-02-12

Status : Active

Type : II

Aarti Industries Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-25

Pay. Date : 2014-12-05

DMF Number : 28833

Submission : 2014-12-05

Status : Active

Type : II

Medichem

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-22

Pay. Date : 2013-09-26

DMF Number : 22744

Submission : 2009-04-20

Status : Active

Type : II

Megafine Pharma

09

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25954

Submission : 2011-10-26

Status : Active

Type : II

fermion