Darifenacin Hydrobromide | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Darifenacin Hydrobromide
South Africa

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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

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xyz-pharma-m-2024-10-07

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

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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xyz-pharma-m-2024-10-07

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Darifenacin Hydrobromide

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 15 USDMF, 9 EU WC, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

27 API Suppliers
15 USDMF
9 EU WC
7 NDC API
15 Listed Suppliers
$ API Reference Price

INTERMEDIATES

8 API Suppliers

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TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Seqens, 3 DKSH, 3 Boai NKY Pharmaceuticals Ltd, 8 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 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 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, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives, 50 Fillers, Diluents & Binders, 28 Controlled & Modified Release, 20 Direct Compression, 18 Thickeners and Stabilizers, 17 Lubricants & Glidants, 14 Topical, 13 Co-Processed Excipients, 11 Film Formers & Plasticizers, 11 Granulation, 8 Solubilizers, 7 Parenteral, 7 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 3 Chewable & Orodispersible Aids, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

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

DIGITAL CONTENT

12 NEWS #PharmaBuzz

12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

10 Finished Drug Prices, 2 Annual Reports

10 Finished Drug 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

3 USP, 4 Others

3 USP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 4,535 Xls

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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

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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

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02

Pharmacare Limited, Woodmead

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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

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03

Pharmacare Limited, Woodmead

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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

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Macleods Pharmaceuticals SA (Pty) Ltd

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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

05

Macleods Pharmaceuticals SA (Pty) Ltd

PackExpo

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

PackExpo

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

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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

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Product Web Link

Digital Content

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