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Fluoxetine

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ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 26 USDMF, 16 CEP/COS, 3 EU WC, 28 KDMF, 19 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

463 FDF Dossiers, 159 FDA Orange Book, 168 Europe, 45 Canada, 12 Australia, 22 South Africa, 57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 10MG BASE, CAPSULE;ORAL - EQ 20MG BASE, CAPSULE;ORAL - EQ 40MG BASE, TABLET;ORAL - EQ 60MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 2 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 9 DKSH, 2 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

94 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 48 Direct Compression, 44 Disintegrants & Superdisintegrants, 39 Thickeners and Stabilizers, 33 Solubilizers, 33 Controlled & Modified Release, 30 Granulation, 24 Parenteral, 23 Topical, 22 Lubricants & Glidants, 22 Film Formers & Plasticizers, 21 Co-Processed Excipients, 19 Taste Masking, 17 Chewable & Orodispersible Aids, 12 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 8 Rheology Modifiers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 53 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 167 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

21 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 8 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
28/10/2024	Fermion Oy	Finland	FERMION OY	11315	FLUOXETINE HYDROCHLORIDE USP	1995-01-26	Active	II	Complete	2014-10-13	2014-10-02
28/10/2024	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	18980	FLUOXETINE HYDROCHLORIDE USP	2005-11-23	Active	II	N/A

Fluoxetine

Fluoxetine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

51 API Suppliers

26 USDMF

16 CEP/COS

3 EU WC

28 KDMF

19 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

463 FDF Dossiers

159 FDA Orange Book

168 Europe

45 Canada

12 Australia

22 South Africa

57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 10MG BASE

CAPSULE;ORAL - EQ 20MG BASE

CAPSULE;ORAL - EQ 40MG BASE

TABLET;ORAL - EQ 60MG BASE

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik

2 Rochem International Inc

17 SPI Pharma

2 Seqens

9 DKSH

2 Jai Radhe Sales

7 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

32 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

13 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

33 Kerry

4 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

8 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

22 Roquette

16 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

3 The Dow Chemical Company

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons