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

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Labetalol Hydrochloride
South Africa

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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

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xyz-pharma-m-2024-10-07

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Labetalol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 19 USDMF, 7 CEP/COS, 4 JDMF, 4 EU WC, 13 NDC API, 16 Listed Suppliers, $ API Reference Price

32 API Suppliers
19 USDMF
7 CEP/COS
4 JDMF
4 EU WC
13 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

130 FDF Dossiers, 78 FDA Orange Book, 12 Europe, 11 Canada, 2 Australia, 2 South Africa, 25 Listed Dossiers

130 FDF Dossiers
78 FDA Orange Book
12 Europe
11 Canada
2 Australia
2 South Africa
25 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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 3 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 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, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 36 Direct Compression, 31 Disintegrants & Superdisintegrants, 28 Controlled & Modified Release, 24 Thickeners and Stabilizers, 20 Granulation, 18 Solubilizers, 16 Co-Processed Excipients, 15 Lubricants & Glidants, 13 Topical, 12 Film Formers & Plasticizers, 11 Parenteral, 9 Chewable & Orodispersible Aids, 7 Taste Masking, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 3 Surfactant & Foaming Agents

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

12 Finished Drug Prices

12 Finished Drug Prices

MARKET PLACE

23 APIs, 11 FDF Dossiers

23 APIs
11 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

3 EDQM
1 USP
2 Others

$ API Ref.Price (USD/KG) : 187 Xls

Filters

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filter Applicant Reset all filters

2 All

01 1Pharmacare Limited, Woodmead

02 1Glaxosmithkline South Africa (Pty) Ltd - Cape Town

filter Active Ingredients Reset all filters

2 All

01 1Labetalol

02 1Labetalol Hydrochloride

filter Dosage Form Reset all filters

2 All

01 1INJ

02 1TAB

filter Brand Name Reset all filters

2 All

01 1Trandate

02 1Trandate Injection

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Pharmtech & Ingredients

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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

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Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Glaxosmithkline South Africa (Pty) Ltd -...

Pharmtech & Ingredients

Not Confirmed

Glaxosmithkline South Africa (Pty) Ltd -...

Pharmtech & Ingredients

Not Confirmed

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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

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Digital Content

Corporate PDF

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