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Approved Marketing Authorisations (MA) containing Darifenacin Hydrobromide in Europe. Original Data : EMA Website

Client Email

Product

Darifenacin Hydrobromide
Europe

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

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Darifenacin Hydrobromide

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 15 USDMF, 9 EU WC, 7 NDC API, 16 Listed Suppliers, $ API Reference Price

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

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

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TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Granulation, 11 Film Formers & Plasticizers, 8 Solubilizers, 7 Parenteral, 7 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Emulsifying Agents, 5 Empty Capsules, 4 Taste Masking, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 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 Granulation
11 Film Formers & Plasticizers
8 Solubilizers
7 Parenteral
7 Disintegrants & Superdisintegrants
6 API Stability Enhancers
5 Emulsifying Agents
5 Empty Capsules
4 Taste Masking
4 Coloring Agents
4 Vegetarian Capsules
3 Rheology Modifiers
3 Chewable & Orodispersible Aids
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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14 All

01 4CPS Cito Pharma Services GmbH

02 2Macleods Pharmaceuticals Limited

03 2Meru Labs Luxco S.à rl,

04 6Merus Labs Luxco S. à R. L.

filter Active Ingredients Reset all filters

14 All

01 8Darifenacin

02 4Darifenacinum

03 2darifenacin hydrobromide

filter Dosage Form Reset all filters

14 All

01 6Depottablett

02 2ER TABLET

03 2PROLONGED-RELEASE TABLET

04 4Ret Tabl

filter Country Reset all filters

14 All

01 6Norway

02 2Sweden

03 4Switzerland

04 2United Kingdom

filter Brand Name Reset all filters

14 All

01 12Emselex

02 2Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

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01

Macleods Pharmaceuticals Limited

Discovery on Target

Not Confirmed

Macleods Pharmaceuticals Limited

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Digital Content

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Darifenacin

Brand Name :

Dosage Form : ER TABLET

Dosage Strength : 7.5MG

Packaging :

Approval Date :

Application Number : 91190

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Portfolio PDF

Product Web Link

Digital Content

02

Macleods Pharmaceuticals Limited

Discovery on Target

Not Confirmed

Macleods Pharmaceuticals Limited

Discovery on Target

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Digital Content

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Darifenacin

Brand Name :

Dosage Form : ER TABLET

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number : 91190

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Portfolio PDF

Product Web Link

Digital Content

03

Meru Labs Luxco S.à rl,

Country

Discovery on Target

Not Confirmed

Meru Labs Luxco S.à rl,

Country

Discovery on Target

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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Regulatory Info :

Registration Country : Sweden

darifenacin hydrobromide

Brand Name : Emselex

Dosage Form : PROLONGED-RELEASE TABLET

Dosage Strength : 7.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

04

Meru Labs Luxco S.à rl,

Country

Discovery on Target

Not Confirmed

Meru Labs Luxco S.à rl,

Country

Discovery on Target

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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Regulatory Info :

Registration Country : Sweden

darifenacin hydrobromide

Brand Name : Emselex

Dosage Form : PROLONGED-RELEASE TABLET

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

05

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

Not Confirmed

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

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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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Regulatory Info :

Registration Country : Norway

Darifenacin

Brand Name : Emselex

Dosage Form : Depottablett

Dosage Strength : 15 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

06

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

Not Confirmed

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

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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Country

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Digital Content

Regulatory Info :

Registration Country : Norway

Darifenacin

Brand Name : Emselex

Dosage Form : Depottablett

Dosage Strength : 15 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

Not Confirmed

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

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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Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Norway

Darifenacin

Brand Name : Emselex

Dosage Form : Depottablett

Dosage Strength : 15 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

Not Confirmed

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

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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Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Norway

Darifenacin

Brand Name : Emselex

Dosage Form : Depottablett

Dosage Strength : 7.5 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

Not Confirmed

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

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

Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Norway

Darifenacin

Brand Name : Emselex

Dosage Form : Depottablett

Dosage Strength : 7.5 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

Not Confirmed

Merus Labs Luxco S. à R. L.

Country

Discovery on Target

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

Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Norway

Darifenacin

Brand Name : Emselex

Dosage Form : Depottablett

Dosage Strength : 7.5 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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