Fluoxetine Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Fluoxetine Hydrochloride
South Africa

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

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Fluoxetine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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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

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

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CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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, 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, 9 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, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 47 Direct Compression, 43 Disintegrants & Superdisintegrants, 39 Thickeners and Stabilizers, 33 Controlled & Modified Release, 32 Solubilizers, 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

92 Fillers, Diluents & Binders
60 Coating Systems & Additives
47 Direct Compression
43 Disintegrants & Superdisintegrants
39 Thickeners and Stabilizers
33 Controlled & Modified Release
32 Solubilizers
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

4 DATA COMPILATION #PharmaFlow
53 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

2 US Medicaid Prescriptions
167 Finished Drug Prices
3 Annual Reports

MARKET PLACE

22 APIs, 4 FDF Dossiers

22 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 9 Others

3 EDQM
3 USP
9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 113 Xls

Filters

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22 All

01 3Pharmacare Limited, Woodmead

02 2Biotech Laboratories (Pty) Ltd

03 2Cipla Medpro (Pty) Ltd

04 1Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

05 1Dr Reddy's Laboratories (Pty) Ltd

06 3Eli Lilly (SA) (Pty) Ltd

07 3Oethmaan Biosims (Pty) Ltd

08 1Ranbaxy Pharmaceuticals (Pty) Ltd

09 3Sandoz SA (Pty) Ltd

10 1Unichem SA (Pty) Ltd

11 1Unimed Healthcare (Pty) Ltd

12 1Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

22 All

01 19Fluoxetine

02 3Fluoxetine hydrochloride

filter Dosage Form Reset all filters

22 All

01 18CAP

02 2DSP

03 2TAB

filter Brand Name Reset all filters

22 All

01 1A-Lennon Fluoxetine

02 1FLUOXITINE 20 UNIMED

03 3Fluoxetine 20 Oethmaan

04 1Fluoxetine Actor 20

05 2Fluoxetine Biotech 20

06 1Lilly-Fluoxetine

07 2Lorien

08 1Nuzak

09 1ProHexal 40T

10 1ProHexal 20 T

11 1Prohexal 20

12 1Prolax Capsules

13 1Prozac 20

14 1Prozac Tablets

15 1Ranflocs 20 Capsules

16 1Rezak

17 1Trizac 20 mg

18 1Zydus Fluoxetine 20 mg

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Lorien

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : A-Lennon Fluoxetine

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Lorien

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Biotech Laboratories (Pty) Ltd

Pharma, Lab & Chemical Expo

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Biotech Laboratories (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Fluoxetine hydrochloride

Brand Name : Fluoxetine Biotech 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Biotech Laboratories (Pty) Ltd

Pharma, Lab & Chemical Expo

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Biotech Laboratories (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluoxetine hydrochloride

Brand Name : Fluoxetine Biotech 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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06

Cipla Medpro (Pty) Ltd

Pharma, Lab & Chemical Expo

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Cipla Medpro (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Fluoxetine Actor 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Cipla Medpro (Pty) Ltd

Pharma, Lab & Chemical Expo

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Cipla Medpro (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Nuzak

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Eli Lilly (SA) (Pty) Ltd

Pharma, Lab & Chemical Expo

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Eli Lilly (SA) (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Prozac 20

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Dezzo Trading 392 (Pty) Limited T/A Indo...

Pharma, Lab & Chemical Expo

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Dezzo Trading 392 (Pty) Limited T/A Indo...

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Prolax Capsules

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Website

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10

Dr Reddy's Laboratories (Pty) Ltd

Country

Pharma, Lab & Chemical Expo

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Dr Reddy's Laboratories (Pty) Ltd

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Pharma, Lab & Chemical Expo

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Rezak

Dosage Form : CAP

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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