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

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Hydroxyzine Dihydrochloride
South Africa

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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

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Hydroxyzine Dihydrochloride

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 15 USDMF, 5 CEP/COS, 6 EU WC, 4 KDMF, 23 NDC API, 17 Listed Suppliers, $ API Reference Price

27 API Suppliers
15 USDMF
5 CEP/COS
6 EU WC
4 KDMF
23 NDC API
17 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 145 FDA Orange Book, 37 Europe, 11 Canada, 6 South Africa, 19 Listed Dossiers

218 FDF Dossiers
145 FDA Orange Book
37 Europe
11 Canada
6 South Africa
19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 10MG/5ML, INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 10MG/5ML
INJECTABLE;INJECTION - 25MG/ML
INJECTABLE;INJECTION - 50MG/ML
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG

DIGITAL CONTENT

8 NEWS #PharmaBuzz

8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

32 Finished Drug Prices

32 Finished Drug Prices

MARKET PLACE

9 APIs, 3 FDF Dossiers

9 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 2 USP, 2 Others

1 EDQM
2 USP
2 Others

$ API Ref.Price (USD/KG) : 152 Xls

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filter Applicant Reset all filters

6 All

01 4AHN Pharma (Pty) Limited

02 1Mylan (Pty) Ltd

03 1Pharma-Q Holdings (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 5Hydroxyzine

02 1Hydroxyzine hydrochloride

filter Dosage Form Reset all filters

6 All

01 3INJ

02 1SYR

03 2TAB

filter Brand Name Reset all filters

6 All

01 3Aterax

02 1Aterax 2ml

03 1Neurax

04 1Pharma-Q Hydroxyzine Injection 100,0Mg/2Ml

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01

AHN Pharma (Pty) Limited

BioAsia

Not Confirmed

AHN Pharma (Pty) Limited

BioAsia

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 : Originator

Registration Country : South Africa

Hydroxyzine

Brand Name : Aterax

Dosage Form : SYR

Dosage Strength : 2mg/ml

Packaging : 100X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

AHN Pharma (Pty) Limited

BioAsia

Not Confirmed

AHN Pharma (Pty) Limited

BioAsia

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 : Originator

Registration Country : South Africa

Hydroxyzine

Brand Name : Aterax

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Website

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03

AHN Pharma (Pty) Limited

BioAsia

Not Confirmed

AHN Pharma (Pty) Limited

BioAsia

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 : Originator

Registration Country : South Africa

Hydroxyzine

Brand Name : Aterax

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

AHN Pharma (Pty) Limited

BioAsia

Not Confirmed

AHN Pharma (Pty) Limited

BioAsia

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Hydroxyzine

Brand Name : Aterax 2ml

Dosage Form : INJ

Dosage Strength : 100mg/2ml

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Mylan (Pty) Ltd

BioAsia

Not Confirmed

Mylan (Pty) Ltd

BioAsia

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Regulatory Info : Generic

Registration Country : South Africa

Hydroxyzine hydrochloride

Brand Name : Neurax

Dosage Form : INJ

Dosage Strength : 100mg/2ml

Packaging : 2X10mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Pharma-Q Holdings (Pty) Ltd

Country

BioAsia

Not Confirmed

Pharma-Q Holdings (Pty) Ltd

Country

BioAsia

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Regulatory Info : Generic

Registration Country : South Africa

Hydroxyzine

Brand Name : Pharma-Q Hydroxyzine Injection 100,0Mg/2Ml

Dosage Form : INJ

Dosage Strength : 100mg/2ml

Packaging : 2X10mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Digital Content

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