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

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Enablex
South Africa

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Enablex

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 15 USDMF, 7 EU WC, 7 NDC API, 13 Listed Suppliers, $ API Reference Price

26 API Suppliers
15 USDMF
7 EU WC
7 NDC API
13 Listed Suppliers
$ API Reference Price

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers, 20 FDA Orange Book, 14 Europe, 6 Canada, 5 South Africa, 10 Listed Dossiers

55 FDF Dossiers
20 FDA Orange Book
14 Europe
6 Canada
5 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 DKSH, 2 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 9 BASF, 3 Clariant, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 27 Controlled & Modified Release, 18 Thickeners and Stabilizers, 16 Lubricants & Glidants, 15 Topical, 14 Co-Processed Excipients, 12 Direct Compression, 11 Granulation, 10 Film Formers & Plasticizers, 8 Solubilizers, 6 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Emulsifying Agents, 5 Rheology Modifiers, 5 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 3 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents

48 Coating Systems & Additives
47 Fillers, Diluents & Binders
27 Controlled & Modified Release
18 Thickeners and Stabilizers
16 Lubricants & Glidants
15 Topical
14 Co-Processed Excipients
12 Direct Compression
11 Granulation
10 Film Formers & Plasticizers
8 Solubilizers
6 Disintegrants & Superdisintegrants
6 API Stability Enhancers
5 Emulsifying Agents
5 Rheology Modifiers
5 Parenteral
5 Empty Capsules
4 Vegetarian Capsules
4 Taste Masking
4 Coloring Agents
3 Chewable & Orodispersible Aids
2 Surfactant & Foaming Agents

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 Regulatory FDF Prices, 2 Annual Reports

10 Regulatory FDF Prices
2 Annual Reports

MARKET PLACE

2 APIs, 4 FDF Dossiers

2 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 4,444 Xls

Filters

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FILTER :

filter Applicant Reset all filters

5 All

01 3Pharmacare Limited, Woodmead

02 2Macleods Pharmaceuticals SA (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 3Darifenacin Hydrobromide

02 2darifenacin

filter Dosage Form Reset all filters

5 All

01 2SRT

02 3TAB

filter Brand Name Reset all filters

5 All

01 1Enablex 15mg

02 2Enablex 7,5mg

03 1Floden CR 15 mg

04 1Floden CR 7.5 mg

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Specialty & Agro Chemical

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

Darifenacin Hydrobromide

Brand Name : Enablex 7,5mg

Dosage Form : TAB

Dosage Strength : 7.5mg

Packaging : 28X1mg

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

Pharmacare Limited, Woodmead

Specialty & Agro Chemical

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

Darifenacin Hydrobromide

Brand Name : Enablex 7,5mg

Dosage Form : TAB

Dosage Strength : 7.5mg

Packaging : 14X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Pharmacare Limited, Woodmead

Specialty & Agro Chemical

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

Darifenacin Hydrobromide

Brand Name : Enablex 15mg

Dosage Form : TAB

Dosage Strength : 15mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Macleods Pharmaceuticals SA (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

Specialty & Agro Chemical

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

darifenacin

Brand Name : Floden CR 7.5 mg

Dosage Form : SRT

Dosage Strength : 7.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Macleods Pharmaceuticals SA (Pty) Ltd

Specialty & Agro Chemical

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

Specialty & Agro Chemical

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

darifenacin

Brand Name : Floden CR 15 mg

Dosage Form : SRT

Dosage Strength : 15mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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