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Dornase Alfa
FDF Dossiers

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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

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pharmacompass-2-m-2025-10-20

Dornase Alfa

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 1 FDA Orange Book, 30 Europe, 1 Canada, 2 Australia, 1 South Africa

35 FDF Dossiers
1 FDA Orange Book
30 Europe
1 Canada
2 Australia
1 South Africa

DIGITAL CONTENT

1 News #PharmaBuzz

1 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Regulatory FDF Prices, 11 Annual Reports

1 US Medicaid Prescriptions
1 Regulatory FDF Prices
11 Annual Reports

MARKET PLACE

2 APIs, 1 FDF Dossiers

2 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

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35 All

01 3Abacus Medicine

02 1Ebb Medical

03 8F. Hoffmann-La Roche

04 1Genentech

05 6Medartuum

06 1Northern Medical Group Aps

07 6ORIFARM GROUP AS

08 1Omnia L?kemedel Ab

09 5Paranova Pharmaceuticals Ab

10 2Pharmachim Ab

11 1Unimedic AB

filter Dosage Reset all filters

35 All

01 27Inhalation Solution

02 1Inhalation liquid for nebulizer, solution

03 1SLN

04 1SOLUTION

05 1Solution For Inhalation

06 1Solution For Nebulizer Inhalation

07 1VIAL

08 2Blank

filter Regulatory Info Reset all filters

35 All

01 1Allowed

02 12Approved

03 1Authorized

04 15Deregistered

05 1Originator

06 1Prescription

07 4Blank

filter Brand Name Reset all filters

35 All

01 2PULMOZYME

02 33Pulmozyme

filter Country Reset all filters

35 All

01 2Australia

02 1Canada

03 1Norway

04 1South Africa

05 1Spain

06 27Sweden

07 1Switzerland

08 1USA

List of Suppliers

Product Main Page

01

Abacus Medicine

ACI Convention

Not Confirmed

Abacus Medicine

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21/12/2021

Application Number : 20210616000019

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Abacus Medicine

ACI Convention

Not Confirmed

Abacus Medicine

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21/12/2021

Application Number : 20210603000039

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Abacus Medicine

ACI Convention

Not Confirmed

Abacus Medicine

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/09/2014

Application Number : 20140208000076

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Ebb Medical

ACI Convention

Not Confirmed

Ebb Medical

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/07/2024

Application Number : 20240416000186

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

F. Hoffmann-La Roche

ACI Convention

Not Confirmed

F. Hoffmann-La Roche

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Norway

Dornase alfa

Brand Name : Pulmozyme

Dosage Form : Inhalation liquid for nebulizer, solution

Dosage Strength : 1mg/ml

Packaging : Ampoule av plast 30 2.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

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Digital Content

Corporate PDF

06

F. Hoffmann-La Roche

ACI Convention

Not Confirmed

F. Hoffmann-La Roche

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/09/1993

Application Number : 19930904000029

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Genentech

ACI Convention

Not Confirmed

Genentech

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : USA

DORNASE ALFA

Brand Name : PULMOZYME

Dosage Form : VIAL

Dosage Strength : 1MG/ML

Packaging :

Approval Date :

Application Number : 103532

Regulatory Info :

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Medartuum

ACI Convention

Not Confirmed

Medartuum

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 20/11/2013

Application Number : 20130228000026

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Medartuum

ACI Convention

Not Confirmed

Medartuum

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 26/09/2018

Application Number : 20170530000062

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Medartuum

ACI Convention

Not Confirmed

Medartuum

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 24/10/2018

Application Number : 20180321000065

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

11

Medartuum

ACI Convention

Not Confirmed

Medartuum

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21/11/2018

Application Number : 20180110000023

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

12

Medartuum

ACI Convention

Not Confirmed

Medartuum

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 20/11/2013

Application Number : 20130228000019

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

13

Medartuum

ACI Convention

Not Confirmed

Medartuum

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 25/02/2020

Application Number : 20191009000062

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

14

ORIFARM GROUP AS

ACI Convention

Not Confirmed

ORIFARM GROUP AS

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 10/08/2021

Application Number : 20210115000046

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

15

ORIFARM GROUP AS

ACI Convention

Not Confirmed

ORIFARM GROUP AS

ACI Convention

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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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 29/01/2014

Application Number : 20130702000054

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

16

ORIFARM GROUP AS

ACI Convention

Not Confirmed

ORIFARM GROUP AS

ACI Convention

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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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 29/01/2014

Application Number : 20130702000078

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

17

ORIFARM GROUP AS

ACI Convention

Not Confirmed

ORIFARM GROUP AS

ACI Convention

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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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 17/12/2014

Application Number : 20140716000049

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

18

Unimedic AB

ACI Convention

Not Confirmed

Unimedic AB

ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/09/2014

Application Number : 20140208000083

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

19

Northern Medical Group Aps

Country

ACI Convention

Not Confirmed

Northern Medical Group Aps

Country

ACI Convention

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 19/10/2016

Application Number : 20160122000099

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

20

Omnia L?kemedel Ab

Country

ACI Convention

Not Confirmed

Omnia L?kemedel Ab

Country

ACI Convention

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 : Deregistered

Registration Country : Sweden

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 07/02/2013

Application Number : 20111214000060

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

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Virtual Booth

Digital Content

Website

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