Biomarin Pharmaceutical | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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BioMarin Pharmaceutical
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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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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BioMarin Pharmaceutical

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DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 455 News #PharmaBuzz

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DEVELOPMENTS

121 Drugs in Development

121 Drugs in Development

FINISHED DOSAGE FORMULATIONS

52 FDF Dossiers, 13 FDA Orange Book, 17 Europe, 8 Canada, 14 Australia

52 FDF Dossiers
13 FDA Orange Book
17 Europe
8 Canada
14 Australia

INSPECTIONS & REGISTRATIONS

17 FDA

17 FDA

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filter Legal Name Reset all filters

17 All

01 5BioMarin Pharmaceutical Inc.

02 12BioMarin Pharmaceutical, Inc.

filter District Decision Reset all filters

17 All

01 7No Action Indicated

02 10Voluntary Action Indicated

filter Inspection End Date Reset all filters

17 All

01 12025-03-26

02 12024-08-19

03 12020-11-06

04 22020-02-28

05 12017-12-14

06 12017-12-07

07 12016-11-04

08 12014-04-17

09 12014-02-17

10 12013-09-24

11 12013-06-28

12 12011-11-03

13 12010-07-15

14 22009-09-25

15 12009-03-20

filter City Reset all filters

17 All

01 12Novato

02 5San Rafael

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17 All

01 17U.S.A

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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 : 2025-03-26

BioMarin Pharmaceutical

City : Novato

State : California

Country/Area : U.S.A

Zip : 94949

District :

Center :

Project Area : Human Cellular, Tissue, and Gene...

District Decision : No Action Indicated

Inspection End Date : 2025-03-26

Product
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Data Compilation
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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 : Voluntary Action Indicated

Inspection End Date : 2024-08-19

BioMarin Pharmaceutical

City : Novato

State : California

Country/Area : U.S.A

Zip : 94949

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-08-19

Product
Web Link

Stock Recap
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Data Compilation
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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 : 2020-11-06

BioMarin Pharmaceutical

City : San Rafael

State : California

Country/Area : U.S.A

Zip : 94901

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2020-11-06

Product
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Data Compilation
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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 : 2020-02-28

BioMarin Pharmaceutical

City : San Rafael

State : California

Country/Area : U.S.A

Zip : 94901

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-02-28

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 : 2020-02-28

BioMarin Pharmaceutical

City : San Rafael

State : California

Country/Area : U.S.A

Zip : 94901

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-02-28

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 : 2017-12-14

BioMarin Pharmaceutical

City : Novato

State : California

Country/Area : U.S.A

Zip : 94949

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-12-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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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 : 2017-12-07

BioMarin Pharmaceutical

City : San Rafael

State : California

Country/Area : U.S.A

Zip : 94901

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2017-12-07

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 : No Action Indicated

Inspection End Date : 2016-11-04

BioMarin Pharmaceutical

City : Novato

State : California

Country/Area : U.S.A

Zip : 94949

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2016-11-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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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 : 2014-04-17

BioMarin Pharmaceutical

City : Novato

State : California

Country/Area : U.S.A

Zip : 94949

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-04-17

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 : 2014-02-17

BioMarin Pharmaceutical

City : San Rafael

State : California

Country/Area : U.S.A

Zip : 94901

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-02-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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