Ethambutol Dihydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Ethambutol Dihydrochloride
South Africa

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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xyz-pharma-m-2025-01-06

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Ethambutol Dihydrochloride

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 4 USDMF, 3 CEP/COS, 3 JDMF, 3 EU WC, 1 KDMF, 2 NDC API, 2 Listed Suppliers, $ API Reference Price

10 API Suppliers
4 USDMF
3 CEP/COS
3 JDMF
3 EU WC
1 KDMF
2 NDC API
2 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 9 FDA Orange Book, 5 Europe, 2 Canada, 11 South Africa, 4 Listed Dossiers

31 FDF Dossiers
9 FDA Orange Book
5 Europe
2 Canada
11 South Africa
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 400MG

TABLET;ORAL - 100MG
TABLET;ORAL - 400MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 7 DKSH, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 27 BASF, 1 Clariant, 11 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 26 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 5 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 28 Solubilizers, 28 Controlled & Modified Release, 27 Direct Compression, 23 Film Formers & Plasticizers, 23 Thickeners and Stabilizers, 22 Granulation, 19 Lubricants & Glidants, 17 Taste Masking, 17 Topical, 16 Parenteral, 15 Disintegrants & Superdisintegrants, 14 Co-Processed Excipients, 9 Empty Capsules, 9 Emulsifying Agents, 7 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 3 Rheology Modifiers, 1 Soft Gelatin

72 Fillers, Diluents & Binders
49 Coating Systems & Additives
28 Solubilizers
28 Controlled & Modified Release
27 Direct Compression
23 Film Formers & Plasticizers
23 Thickeners and Stabilizers
22 Granulation
19 Lubricants & Glidants
17 Taste Masking
17 Topical
16 Parenteral
15 Disintegrants & Superdisintegrants
14 Co-Processed Excipients
9 Empty Capsules
9 Emulsifying Agents
7 Chewable & Orodispersible Aids
6 API Stability Enhancers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Coloring Agents
3 Rheology Modifiers
1 Soft Gelatin

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices

1 US Medicaid Prescriptions
3 Finished Drug Prices

MARKET PLACE

2 APIs

2 APIs

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 382 Xls

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11 All

01 3Medicine Developers International CC

02 4Sandoz SA (Pty) Ltd

03 4Sandoz SA Pty Ltd

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11 All

01 4Ethambutol HCl

02 7Ethambutol Hydrochloride

filter Dosage Form Reset all filters

11 All

01 11TAB

filter Brand Name Reset all filters

11 All

01 3Antib-4

02 4Rimstar 4-Fdc

03 2Sandoz Ethambutol HCI 400

04 2Sandoz Ethambutol HCl 400

List of Suppliers

Product Main Page

01

Sandoz SA Pty Ltd

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Sandoz SA Pty Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol HCl

Brand Name : Rimstar 4-Fdc

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

02

Sandoz SA Pty Ltd

PharmaVenue

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Sandoz SA Pty Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol HCl

Brand Name : Rimstar 4-Fdc

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

03

Sandoz SA Pty Ltd

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Sandoz SA Pty Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol HCl

Brand Name : Rimstar 4-Fdc

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 84X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

04

Sandoz SA Pty Ltd

PharmaVenue

Not Confirmed

Sandoz SA Pty Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol HCl

Brand Name : Rimstar 4-Fdc

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 112X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

05

Sandoz SA (Pty) Ltd

PharmaVenue

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Sandoz SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol Hydrochloride

Brand Name : Sandoz Ethambutol HCI 400

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

06

Sandoz SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol Hydrochloride

Brand Name : Sandoz Ethambutol HCl 400

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

07

Sandoz SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ethambutol Hydrochloride

Brand Name : Sandoz Ethambutol HCl 400

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 84X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Product Web Link

Digital Content

08

Medicine Developers International CC

Country

PharmaVenue

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Medicine Developers International CC

Country

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Regulatory Info : Generic

Registration Country : South Africa

Ethambutol Hydrochloride

Brand Name : Antib-4

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 84X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Medicine Developers International CC

Country

PharmaVenue

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Medicine Developers International CC

Country

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Regulatory Info : Generic

Registration Country : South Africa

Ethambutol Hydrochloride

Brand Name : Antib-4

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 112X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Medicine Developers International CC

Country

PharmaVenue

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Medicine Developers International CC

Country

PharmaVenue

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Regulatory Info : Generic

Registration Country : South Africa

Ethambutol Hydrochloride

Brand Name : Antib-4

Dosage Form : TAB

Dosage Strength : 275mg

Packaging : 500X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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