Opella Healthcare Group | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Opella Healthcare Group
FDA

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

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Opella Healthcare Group

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 3 News #PharmaBuzz

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DEVELOPMENTS

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FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 141 Europe, 17 South Africa

158 FDF Dossiers
141 Europe
17 South Africa

INSPECTIONS & REGISTRATIONS

8 FDA

8 FDA

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filter Legal Name Reset all filters

8 All

01 2Opella Healthcare Hungary Ltd.

02 6Opella Healthcare International SAS

filter District Decision Reset all filters

8 All

01 3No Action Indicated

02 5Voluntary Action Indicated

filter Inspection End Date Reset all filters

8 All

01 12025-01-10

02 12019-10-31

03 12017-06-23

04 12015-09-18

05 12013-09-19

06 12011-11-17

07 12011-10-21

08 12009-09-10

filter City Reset all filters

8 All

01 6Compiegne

02 2Veresegyhaz

filter Country/Area Reset all filters

8 All

01 6France

02 2Hungary

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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 : Voluntary Action Indicated

Inspection End Date : 2025-01-10

Opella Healthcare Group

City : Compiegne

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-01-10

Product
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Stock Recap
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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 : 2019-10-31

Opella Healthcare Group

City : Compiegne

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-10-31

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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 : Voluntary Action Indicated

Inspection End Date : 2017-06-23

Opella Healthcare Group

City : Compiegne

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-06-23

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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 : 2015-09-18

Opella Healthcare Group

City : Compiegne

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-09-18

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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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 : 2013-09-19

Opella Healthcare Group

City : Compiegne

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-09-19

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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 : No Action Indicated

Inspection End Date : 2011-11-17

Opella Healthcare Group

City : Veresegyhaz

State :

Country/Area : Hungary

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2011-11-17

Product
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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 : 2011-10-21

Opella Healthcare Group

City : Compiegne

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2011-10-21

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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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 : 2009-09-10

Opella Healthcare Group

City : Veresegyhaz

State :

Country/Area : Hungary

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-09-10

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