Labetalol | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Labetalol
South Africa

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

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

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

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

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xyz-pharma-m-2025-06-09

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Labetalol

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ACTIVE PHARMA INGREDIENTS

34 API Suppliers, 18 USDMF, 7 CEP/COS, 4 JDMF, 5 EU WC, 12 NDC API, 17 Listed Suppliers, $ API Reference Price

34 API Suppliers
18 USDMF
7 CEP/COS
4 JDMF
5 EU WC
12 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

11 Intermediate Suppliers

11 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

134 FDF Dossiers, 78 FDA Orange Book, 12 Europe, 11 Canada, 2 Australia, 3 South Africa, 28 Listed Dossiers

134 FDF Dossiers
78 FDA Orange Book
12 Europe
11 Canada
2 Australia
3 South Africa
28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 5 DKSH, 3 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 30 Disintegrants & Superdisintegrants, 27 Controlled & Modified Release, 26 Direct Compression, 24 Thickeners and Stabilizers, 20 Granulation, 18 Solubilizers, 17 Co-Processed Excipients, 14 Lubricants & Glidants, 13 Topical, 12 Film Formers & Plasticizers, 9 Chewable & Orodispersible Aids, 9 Parenteral, 7 Emulsifying Agents, 7 Taste Masking, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

59 Fillers, Diluents & Binders
51 Coating Systems & Additives
30 Disintegrants & Superdisintegrants
27 Controlled & Modified Release
26 Direct Compression
24 Thickeners and Stabilizers
20 Granulation
18 Solubilizers
17 Co-Processed Excipients
14 Lubricants & Glidants
13 Topical
12 Film Formers & Plasticizers
9 Chewable & Orodispersible Aids
9 Parenteral
7 Emulsifying Agents
7 Taste Masking
6 Rheology Modifiers
6 API Stability Enhancers
5 Empty Capsules
4 Vegetarian Capsules
4 Coloring Agents
3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 18 News #PharmaBuzz

1 Data Compilation #PharmaFlow
18 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 Regulatory FDF Prices

12 Regulatory FDF Prices

MARKET PLACE

25 APIs, 11 FDF Dossiers

25 APIs
11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM

3 EDQM

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

Filters

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filter Applicant Reset all filters

3 All

01 1Pharmacare Limited, Woodmead

02 1Adcock Ingram

03 1Glaxosmithkline South Africa (Pty) Ltd - Cape Town

filter Active Ingredients Reset all filters

3 All

01 1Labetalol

02 2Labetalol Hydrochloride

filter Dosage Form Reset all filters

3 All

01 1INF

02 1INJ

03 1TAB

filter Brand Name Reset all filters

3 All

01 1ADCO LABETALOL 5 MG/ML

02 1Trandate

03 1Trandate Injection

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Labetalol Hydrochloride

Brand Name : Trandate Injection

Dosage Form : INJ

Dosage Strength : 5mg/1ml

Packaging : 20X5mg/1ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

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Corporate PDF

02

Adcock Ingram

IOPC

Not Confirmed

Adcock Ingram

IOPC

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

Labetalol Hydrochloride

Brand Name : ADCO LABETALOL 5 MG/ML

Dosage Form : INF

Dosage Strength : 5mg/1ml

Packaging : 40X1mg/1ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Glaxosmithkline South Africa (Pty) Ltd -...

IOPC

Not Confirmed

Glaxosmithkline South Africa (Pty) Ltd -...

IOPC

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

Brand Name : Trandate

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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