Swedish Orphan Biovitrum Ab | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Swedish Orphan Biovitrum AB
FDA

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

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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pharmacompass-1-m-2026-01-12

LEBSA- Your strategic API source for niche molecules.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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pharmacompass-2-m-2025-11-03

Swedish Orphan Biovitrum AB

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 226 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
226 News #PharmaBuzz

DEVELOPMENTS

183 Drugs in Development

183 Drugs in Development

FINISHED DOSAGE FORMULATIONS

164 FDF Dossiers, 12 FDA Orange Book, 132 Europe, 8 Canada, 12 Australia

164 FDF Dossiers
12 FDA Orange Book
132 Europe
8 Canada
12 Australia

REF. STANDARDS & IMPURITIES

1 Others

1 Others

INSPECTIONS & REGISTRATIONS

11 FDA

11 FDA

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FILTER :

filter Legal Name Reset all filters

11 All

01 2CTI Biopharma Corp

02 1Sobi, Inc.

03 8Swedish Orphan Biovitrum AB (Publ)

filter District Decision Reset all filters

11 All

01 4No Action Indicated

02 7Voluntary Action Indicated

filter Inspection End Date Reset all filters

11 All

01 12022-11-22

02 12021-05-25

03 12019-08-29

04 12018-05-04

05 12016-03-22

06 12014-05-01

07 12013-02-22

08 22011-01-27

09 12009-11-18

10 12009-01-20

filter City Reset all filters

11 All

01 2Seattle

02 8Stockholm

03 1Waltham

filter Country/Area Reset all filters

11 All

01 8Sweden

02 3U.S.A

Supplier Virtual Booth

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01

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : No Action Indicated

Inspection End Date : 2022-11-22

Swedish Orphan Biovitrum AB

City : Waltham

State : Massachusetts

Country/Area : U.S.A

Zip : 2451

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2022-11-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : No Action Indicated

Inspection End Date : 2021-05-25

CTI BioPharma Corp

City : Seattle

State : Washington

Country/Area : U.S.A

Zip : 98121

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2021-05-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : No Action Indicated

Inspection End Date : 2019-08-29

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2019-08-29

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-05-04

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-05-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-03-22

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-03-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-05-01

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-05-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : No Action Indicated

Inspection End Date : 2013-02-22

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-02-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-27

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-27

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-27

Swedish Orphan Biovitrum AB

City : Stockholm

State :

Country/Area : Sweden

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-01-27

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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.

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-11-18

CTI BioPharma Corp

City : Seattle

State : Washington

Country/Area : U.S.A

Zip : 98121

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-11-18

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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