Dalbavancin Hydrochloride | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Dalbavancin Hydrochloride
Europe

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Dalbavancin Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 7 USDMF, 4 NDC API, 17 Listed Suppliers, $ API Reference Price

25 API Suppliers
7 USDMF
4 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

11 FDF Dossiers, 1 FDA Orange Book, 10 Europe

11 FDF Dossiers
1 FDA Orange Book
10 Europe

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 BASF, 2 DFE Pharma, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 10 Kerry, 4 Microlex e.U, 2 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 Sigachi Industries

1 Rochem International Inc
13 SPI Pharma
3 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 BASF
2 DFE Pharma
2 Gangwal Chemicals
1 Ingredion Pharma Solutions
10 Kerry
4 Microlex e.U
2 Pluviaendo
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
2 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

26 Fillers, Diluents & Binders, 15 Direct Compression, 12 Chewable & Orodispersible Aids, 10 Granulation, 10 Taste Masking, 7 Disintegrants & Superdisintegrants, 5 Co-Processed Excipients, 5 Parenteral, 1 Solubilizers, 1 Thickeners and Stabilizers

26 Fillers, Diluents & Binders
15 Direct Compression
12 Chewable & Orodispersible Aids
10 Granulation
10 Taste Masking
7 Disintegrants & Superdisintegrants
5 Co-Processed Excipients
5 Parenteral
1 Solubilizers
1 Thickeners and Stabilizers

DIGITAL CONTENT

11 News #PharmaBuzz

11 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Regulatory FDF Prices, 4 Annual Reports

1 US Medicaid Prescriptions
1 Regulatory FDF Prices
4 Annual Reports

MARKET PLACE

8 APIs, 1 FDF Dossiers

8 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 2 Health Canada Patents

1 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 128,762 Xls

Filters

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filter Applicant Reset all filters

10 All

01 1Abbvie Deutschland Gmbh & Co Kg

02 1Abbvie Deutschland Gmbh & Co. Kg

03 1Accord Healthcare Bv

04 1Accord Healthcare Slu

05 1Baxter Holding B.V.

06 1Bioglan Ab

07 1DURATA THERAPEUTICS INT.B.V.

08 1Reig Jofre Laboratory, Sa

09 1Teva Bv

10 1Zentiva Ks

filter Active Ingredients Reset all filters

10 All

01 1Dalbavancin

02 5Dalbavancin Hydrochloride

03 3Dalbavancina

04 1Zeven

filter Dosage Form Reset all filters

10 All

01 1Dalbavancina 500Mg 1 Unit Parenteral Use

02 1Powder For Concentrate And Solution For Infusion

03 8Powder For Concentrate For Solution For Infusion

filter Country Reset all filters

10 All

01 1Italy

02 3Spain

03 6Sweden

filter Brand Name Reset all filters

10 All

01 1Dalbavancin Accord

02 1Dalbavancin Baxter

03 1Dalbavancin Bioglan

04 1Dalbavancin Teva

05 1Dalbavancin Zentiva

06 1Dalbavancina Accord

07 1Dalbavancina Sala

08 3Xydalba

List of Suppliers

Product Main Page

01

Abbvie Deutschland Gmbh & Co Kg

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dalbavancin

Brand Name : Xydalba

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 19/02/2015

Application Number : 20131130000029

Regulatory Info : Approved

Registration Country : Sweden

Abbvie Company Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Abbvie Deutschland Gmbh & Co. Kg

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dalbavancina

Brand Name : Xydalba

Dosage Form : Powder For Concentrate And Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2015-06-27

Application Number : 114986001

Regulatory Info : Authorized

Registration Country : Spain

Abbvie Company Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Accord Healthcare Bv

PREP

Not Confirmed

Accord Healthcare Bv

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Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Accord

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 11/06/2024

Application Number : 20230223000066

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Accord Healthcare Slu

PREP

Not Confirmed

Accord Healthcare Slu

PREP

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dalbavancina

Brand Name : Dalbavancina Accord

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-05-17

Application Number : 89574

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

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05

Baxter Holding B.V.

PREP

Not Confirmed

Baxter Holding B.V.

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Baxter

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 08/07/2024

Application Number : 20230227000031

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Bioglan Ab

PREP

Not Confirmed

Bioglan Ab

PREP

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Bioglan

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 26/04/2024

Application Number : 20230223000011

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

DURATA THERAPEUTICS INT.B.V.

PREP

Not Confirmed

DURATA THERAPEUTICS INT.B.V.

PREP

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Italy

Brand Name : Xydalba

Dosage Form : Dalbavancina 500Mg 1 Unit Parenteral Use

Dosage Strength : 1 bottle groun EV 500 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

08

Reig Jofre Laboratory, Sa

PREP

Not Confirmed

Reig Jofre Laboratory, Sa

PREP

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dalbavancina

Brand Name : Dalbavancina Sala

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500MG

Packaging :

Approval Date : 2024-05-07

Application Number : 89545

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Teva Bv

PREP

Not Confirmed

Teva Bv

PREP

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Teva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 08/07/2024

Application Number : 20230901000074

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zentiva Ks

PREP

Not Confirmed

Zentiva Ks

PREP

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dalbavancin Hydrochloride

Brand Name : Dalbavancin Zentiva

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 500mg

Packaging :

Approval Date : 21/07/2025

Application Number : 20230801000099

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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