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

Please Wait

Applying Filters...

Grow Your Pharma Business Digitally

Find Suppliers : API/FDF
- Search Our Integrated Database
Services
Excipients
Prospector
- Demo Dashboard
Drugs in Dev.
News
Blog
Market Place
Login

Labetalol HCl
South Africa

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

Contact Supplier

Your reliable CDMO partner - agile, scalable, top-quality Small Molecule API & HPAPI solutions from concept to market

Contact Supplier

pharmacompass-1-m-2025-11-24

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

Contact Supplier

Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

Contact Supplier

pharmacompass-2-m-2025-11-03

Labetalol HCl

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 18 USDMF, 7 CEP/COS, 3 JDMF, 5 EU WC, 12 NDC API, 19 Listed Suppliers, $ API Reference Price

36 API Suppliers
18 USDMF
7 CEP/COS
3 JDMF
5 EU WC
12 NDC API
19 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 82 FDA Orange Book, 32 Europe, 11 Canada, 2 Australia, 3 South Africa, 28 Listed Dossiers

158 FDF Dossiers
82 FDA Orange Book
32 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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 5 Ideal Cures, 3 Ingredion Pharma Solutions, 26 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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

46 Coating Systems & Additives, 45 Fillers, Diluents & Binders, 32 Direct Compression, 30 Disintegrants & Superdisintegrants, 27 Thickeners and Stabilizers, 25 Granulation, 22 Controlled & Modified Release, 18 Solubilizers, 14 Topical, 14 Lubricants & Glidants, 13 Parenteral, 11 Chewable & Orodispersible Aids, 11 Film Formers & Plasticizers, 11 Co-Processed Excipients, 8 Taste Masking, 7 Emulsifying Agents, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

46 Coating Systems & Additives
45 Fillers, Diluents & Binders
32 Direct Compression
30 Disintegrants & Superdisintegrants
27 Thickeners and Stabilizers
25 Granulation
22 Controlled & Modified Release
18 Solubilizers
14 Topical
14 Lubricants & Glidants
13 Parenteral
11 Chewable & Orodispersible Aids
11 Film Formers & Plasticizers
11 Co-Processed Excipients
8 Taste Masking
7 Emulsifying Agents
6 Rheology Modifiers
6 API Stability Enhancers
5 Empty Capsules
4 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 19 News #PharmaBuzz

1 Data Compilation #PharmaFlow
19 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 10 Regulatory FDF Prices

17 US Medicaid Prescriptions
10 Regulatory FDF Prices

MARKET PLACE

27 APIs, 11 FDF Dossiers

27 APIs
11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 2 Others

3 EDQM
2 Others

$ API Ref.Price (USD/KG) : 147 Xls

Filters

Reset all filters

Filters

FILTER :

filter Applicant Reset all filters

3 All

01 1Pharmacare Limited, Woodmead

02 1Adcock Ingram Critical Care (Pty) Ltd

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

filter Active Ingredients Reset all filters

3 All

01 1Labetalol

02 1Labetalol Hydrochloride

03 1Labetalol hydrochloride 5,0 mg

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

ISPOR Europe 2025

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.

Contact Supplier

Contact Supplier

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

Digital Content

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

ISPOR Europe 2025

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

ISPOR Europe 2025

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.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Labetalol hydrochloride 5,0 mg

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 -...

ISPOR Europe 2025

Not Confirmed

Glaxosmithkline South Africa (Pty) Ltd -...

ISPOR Europe 2025

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.

Post an Enquiry

Post an Enquiry

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

Contact us
to update this info

Privacy policy
Terms and conditions
Disclaimers
Ask Us!