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

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Ondansetron Hydrochloride
South Africa

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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Ondansetron Hydrochloride

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 20 USDMF, 18 CEP/COS, 6 JDMF, 7 EU WC, 14 KDMF, 22 NDC API, 30 Listed Suppliers, $ API Reference Price

64 API Suppliers
20 USDMF
18 CEP/COS
6 JDMF
7 EU WC
14 KDMF
22 NDC API
30 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

170 FDF Dossiers, 102 FDA Orange Book, 39 Canada, 8 South Africa, 21 Listed Dossiers

170 FDF Dossiers
102 FDA Orange Book
39 Canada
8 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 5 Rochem International Inc, 19 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 25 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 37 Direct Compression, 32 Disintegrants & Superdisintegrants, 29 Thickeners and Stabilizers, 29 Granulation, 29 Taste Masking, 24 Controlled & Modified Release, 23 Parenteral, 22 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 17 Topical, 16 Solubilizers, 14 Co-Processed Excipients, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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

DIGITAL CONTENT

5 News #PharmaBuzz

5 News #PharmaBuzz

GLOBAL SALES INFORMATION

40 US Medicaid Prescriptions, 16 Regulatory FDF Prices

40 US Medicaid Prescriptions
16 Regulatory FDF Prices

MARKET PLACE

18 APIs, 2 FDF Dossiers

18 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP

8 EDQM
1 USP

$ API Ref.Price (USD/KG) : 1,209 Xls

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8 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 6Ranbaxy Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 2Ondansetron (as hydrochloride)

02 6Ondansetron Hydrochloride

filter Dosage Form Reset all filters

8 All

01 2DSP

02 2FCT

03 4INJ

filter Brand Name Reset all filters

8 All

01 1Sabax Ondansetron injection 4mg/2ml

02 1Sabax Ondansetron injection 8mg/4ml

03 1Zofer 4 Mg Injection

04 1Zofer 4 Mg Tablets

05 1Zofer 8 Mg Injection

06 1Zofer 8 Mg Tablets

07 1Zofer Rapitab 4

08 1Zofer Rapitab 8

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron (as hydrochloride)

Brand Name : Sabax Ondansetron injection 4mg/2ml

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 10X2mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron (as hydrochloride)

Brand Name : Sabax Ondansetron injection 8mg/4ml

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 10X4mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 4 Mg Injection

Dosage Form : INJ

Dosage Strength : 2mg /ml

Packaging : 2X5mg /ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 8 Mg Injection

Dosage Form : INJ

Dosage Strength : 2mg /ml

Packaging : 4X5mg /ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 4 Mg Tablets

Dosage Form : FCT

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer 8 Mg Tablets

Dosage Form : FCT

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer Rapitab 4

Dosage Form : DSP

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

BIO Asia-Taiwan

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Zofer Rapitab 8

Dosage Form : DSP

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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