Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-16-methyl-, (11beta,16beta)- | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-16-methyl-, (11beta,16beta)-
Europe

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Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-16-methyl-, (11beta,16beta)-

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ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 8 USDMF, 1 JDMF, 4 EU WC, 9 NDC API, 17 Listed Suppliers, $ API Reference Price

28 API Suppliers
8 USDMF
1 JDMF
4 EU WC
9 NDC API
17 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

17 FDF Dossiers, 3 FDA Orange Book, 5 Europe, 2 Canada, 2 Australia, 5 South Africa

17 FDF Dossiers
3 FDA Orange Book
5 Europe
2 Canada
2 Australia
5 South Africa

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 6 Kirsch Pharma, 1 ACG Worldwide, 2 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 Corel Pharma Chem, 1 Finar, 3 Gangwal Chemicals, 3 Ideal Cures, 9 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 1 Microlex e.U, 1 Novo Excipients, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 The Dow Chemical Company

1 Nanjing Well Pharmaceutical
6 Kirsch Pharma
1 ACG Worldwide
2 Actylis
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
10 Corel Pharma Chem
1 Finar
3 Gangwal Chemicals
3 Ideal Cures
9 Kerry
3 Kima Chemical
6 Lonza Capsugel
1 Microlex e.U
1 Novo Excipients
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
6 Seppic
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 The Dow Chemical Company

EXCIPIENTS BY APPLICATIONS

34 Coating Systems & Additives, 11 Controlled & Modified Release, 7 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Solubilizers, 4 Film Formers & Plasticizers, 3 API Stability Enhancers, 3 Fillers, Diluents & Binders, 2 Granulation, 2 Coloring Agents, 2 Emulsifying Agents, 2 Thickeners and Stabilizers, 2 Taste Masking, 1 Direct Compression, 1 Topical, 1 Rheology Modifiers, 1 Chewable & Orodispersible Aids, 1 Disintegrants & Superdisintegrants

34 Coating Systems & Additives
11 Controlled & Modified Release
7 Parenteral
5 Empty Capsules
4 Vegetarian Capsules
4 Solubilizers
4 Film Formers & Plasticizers
3 API Stability Enhancers
3 Fillers, Diluents & Binders
2 Granulation
2 Coloring Agents
2 Emulsifying Agents
2 Thickeners and Stabilizers
2 Taste Masking
1 Direct Compression
1 Topical
1 Rheology Modifiers
1 Chewable & Orodispersible Aids
1 Disintegrants & Superdisintegrants

DIGITAL CONTENT

1 News #PharmaBuzz

1 News #PharmaBuzz

MARKET PLACE

8 APIs, 1 FDF Dossiers

8 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 Others

3 Others

$ API Ref.Price (USD/KG) : 3,093 Xls

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01 3Dechra Regulatory BV

02 2Dechra Regulatory Bv

03 1Health Organon Sl

04 1Nv Organon

filter Active Ingredients Reset all filters

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01 2Betamethasone Acetate; Betamethasone Sodium Phosphate

02 1Betamethasone Acetate; Florfenicol; Terbinafine

03 1Betamethasone Acetate; Terbinafine

04 1Terbinafin; Betametasonacetat

05 2Terbinafin; Florfenikol; Betametasonacetat

filter Dosage Form Reset all filters

7 All

01 3Ear Drops

02 2Ear Gel

03 1Injectable Solution

04 1Injectable Suspension

filter Country Reset all filters

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01 2Denmark

02 3Norway

03 1Spain

04 1Sweden

filter Brand Name Reset all filters

7 All

01 1Celeston Bifas

02 1Celestone Chronodose Injectable Suspension

03 1DuOtic

04 1Duotic

05 3Osurnia

Symbiotec Betamethasone Acetate

List of Suppliers

Product Main Page

01

Dechra Regulatory BV

SCOPE Summit

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Dechra Regulatory BV

SCOPE Summit

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Regulatory Info : Marketed

Registration Country : Norway

Terbinafin; Betametasonacetat

Brand Name : DuOtic

Dosage Form : Ear Drops

Dosage Strength : 10mg; 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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Corporate PDF

02

Dechra Regulatory BV

SCOPE Summit

Not Confirmed

Dechra Regulatory BV

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Regulatory Info : Marketed

Registration Country : Norway

Terbinafin; Florfenikol; Betametasonacetat

Brand Name : Osurnia

Dosage Form : Ear Drops

Dosage Strength : 10mg; 10mg; 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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Product Web Link

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03

Dechra Regulatory BV

SCOPE Summit

Not Confirmed

Dechra Regulatory BV

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Regulatory Info : Marketed

Registration Country : Norway

Terbinafin; Florfenikol; Betametasonacetat

Brand Name : Osurnia

Dosage Form : Ear Drops

Dosage Strength : 10mg; 10mg; 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

Dechra Regulatory Bv

SCOPE Summit

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Dechra Regulatory Bv

SCOPE Summit

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Regulatory Info : Prescription

Registration Country : Denmark

Betamethasone Acetate; Florfenicol; Terbinafine

Brand Name : Osurnia

Dosage Form : Ear Gel

Dosage Strength : 10mg; 10mg; 1mg

Packaging :

Approval Date : 31-07-2014

Application Number : 28105304413

Regulatory Info : Prescription

Registration Country : Denmark

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05

Dechra Regulatory Bv

SCOPE Summit

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Dechra Regulatory Bv

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Regulatory Info : Prescription

Registration Country : Denmark

Betamethasone Acetate; Terbinafine

Brand Name : Duotic

Dosage Form : Ear Gel

Dosage Strength : 10mg/1mg

Packaging :

Approval Date : 22-11-2024

Application Number : 28107054723

Regulatory Info : Prescription

Registration Country : Denmark

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06

Nv Organon

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Nv Organon

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Regulatory Info : Approved

Registration Country : Sweden

Betamethasone Acetate; Betamethasone Sodium Phosphate

Brand Name : Celeston Bifas

Dosage Form : Injectable Solution

Dosage Strength : 5.7mg/ml

Packaging :

Approval Date : 22/06/1967

Application Number : 19670122000011

Regulatory Info : Approved

Registration Country : Sweden

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07

Health Organon Sl

SCOPE Summit

Not Confirmed

Health Organon Sl

SCOPE Summit

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Regulatory Info : Authorized

Registration Country : Spain

Betamethasone Acetate; Betamethasone Sodium Phosphate

Brand Name : Celestone Chronodose Injectable Suspension

Dosage Form : Injectable Suspension

Dosage Strength :

Packaging :

Approval Date : 01-03-1965

Application Number : 40628

Regulatory Info : Authorized

Registration Country : Spain

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