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

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Ondansetron HCl
South Africa

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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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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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Ondansetron HCl

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 20 USDMF, 18 CEP/COS, 6 JDMF, 7 EU WC, 14 KDMF, 23 NDC API, 31 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers, 102 FDA Orange Book, 40 Europe, 39 Canada, 10 South Africa, 21 Listed Dossiers

212 FDF Dossiers
102 FDA Orange Book
40 Europe
39 Canada
10 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INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for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, 9 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 7 Kirsch Pharma, 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, 26 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

69 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 37 Direct Compression, 32 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 29 Granulation, 29 Taste Masking, 29 Parenteral, 25 Controlled & Modified Release, 22 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 17 Topical, 16 Solubilizers, 13 Co-Processed Excipients, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

69 Fillers, Diluents & Binders
50 Coating Systems & Additives
37 Direct Compression
32 Disintegrants & Superdisintegrants
32 Thickeners and Stabilizers
29 Granulation
29 Taste Masking
29 Parenteral
25 Controlled & Modified Release
22 Lubricants & Glidants
21 Chewable & Orodispersible Aids
19 Film Formers & Plasticizers
17 Topical
16 Solubilizers
13 Co-Processed Excipients
9 Empty Capsules
7 Emulsifying Agents
7 Rheology Modifiers
6 API Stability Enhancers
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
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) : 1,181 Xls

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10 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 6Ranbaxy Pharmaceuticals (Pty) Ltd

03 2Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

10 All

01 2Ondansetron (as hydrochloride)

02 8Ondansetron Hydrochloride

filter Dosage Form Reset all filters

10 All

01 4DSP

02 2FCT

03 4INJ

filter Brand Name Reset all filters

10 All

01 1Sabax Ondansetron injection 4mg/2ml

02 1Sabax Ondansetron injection 8mg/4ml

03 1Vomiz D 4mg

04 1Vomiz D 8mg

05 1Zofer 4 Mg Injection

06 1Zofer 4 Mg Tablets

07 1Zofer 8 Mg Injection

08 1Zofer 8 Mg Tablets

09 1Zofer Rapitab 4

10 1Zofer Rapitab 8

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

The MedTech Conference

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Adcock Ingram Critical Care (Pty) Ltd

The MedTech Conference

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

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02

Adcock Ingram Critical Care (Pty) Ltd

The MedTech Conference

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

The MedTech Conference

Not Confirmed

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Digital Content

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

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Corporate PDF

03

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

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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

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04

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

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Digital Content

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

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Corporate PDF

05

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

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Digital Content

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

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06

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

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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

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07

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

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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

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08

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

The MedTech Conference

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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

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09

Zydus Healthcare SA (Pty) Ltd

Country

The MedTech Conference

Not Confirmed

Zydus Healthcare SA (Pty) Ltd

Country

The MedTech Conference

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Country

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Vomiz D 4mg

Dosage Form : DSP

Dosage Strength : 4mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Digital Content

Website

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10

Zydus Healthcare SA (Pty) Ltd

Country

The MedTech Conference

Not Confirmed

Zydus Healthcare SA (Pty) Ltd

Country

The MedTech Conference

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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Country

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Regulatory Info : Generic

Registration Country : South Africa

Ondansetron Hydrochloride

Brand Name : Vomiz D 8mg

Dosage Form : DSP

Dosage Strength : 8mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Website

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