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Quetiapine

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ACTIVE PHARMA INGREDIENTS

116 API Suppliers, 58 USDMF, 40 CEP/COS, 9 JDMF, 36 EU WC, 33 KDMF, 34 NDC API, 71 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

INTERMEDIATES

34 API Suppliers

34 API Suppliers

FINISHED DOSAGE FORMULATIONS

1365 FDF Dossiers, 198 FDA Orange Book, 700 Europe, 145 Canada, 69 Australia, 109 South Africa, 144 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 300MG BASE, TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 11 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 4 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

82 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 42 Disintegrants & Superdisintegrants, 41 Direct Compression, 35 Controlled & Modified Release, 31 Solubilizers, 28 Thickeners and Stabilizers, 27 Granulation, 20 Co-Processed Excipients, 18 Parenteral, 18 Film Formers & Plasticizers, 17 Topical, 16 Lubricants & Glidants, 10 Emulsifying Agents, 9 Chewable & Orodispersible Aids, 9 Taste Masking, 7 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 57 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 541 Finished Drug Prices, 13 Annual Reports

MARKET PLACE

12 APIs, 10 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 Health Canada Patents

14 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 5 JP, 29 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Fermion Oy	Finland	FERMION OY	19160	QUETIAPINE FUMARATE ACTIVE PHARMACEUTICAL INGREDIENT	2006-02-02	Active	II	N/A
26/09/2024	Cohance Lifesciences	India	COHANCE LIFESCIENCES LTD	32085	QUETIAPINE FUMARATE USP	2017-10-03	Active	II	Complete	2017-12-01	2017-10-18

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

Quetiapine

Quetiapine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

116 API Suppliers

58 USDMF

40 CEP/COS

9 JDMF

36 EU WC

33 KDMF

34 NDC API

71 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

13 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

34 API Suppliers

FINISHED DOSAGE FORMULATIONS

1365 FDF Dossiers

198 FDA Orange Book

700 Europe

145 Canada

69 Australia

109 South Africa

144 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 200MG BASE

TABLET;ORAL - EQ 25MG BASE

TABLET;ORAL - EQ 300MG BASE

TABLET;ORAL - EQ 400MG BASE

TABLET;ORAL - EQ 50MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

2 Seqens

4 DKSH

2 Jai Radhe Sales

11 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 ACG Worldwide

9 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

26 BASF

2 Clariant

11 Corel Pharma Chem

7 DFE Pharma

2 Finar

13 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

38 Kerry

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

TABLET;ORAL - EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons