Chiesi Group | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Chiesi Group
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

Chiesi Group

VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 88 News #PharmaBuzz

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

DEVELOPMENTS

238 Drugs in Development

238 Drugs in Development

FINISHED DOSAGE FORMULATIONS

354 FDF Dossiers, 36 FDA Orange Book, 276 Europe, 14 Canada, 28 Australia

354 FDF Dossiers
36 FDA Orange Book
276 Europe
14 Canada
28 Australia

INSPECTIONS & REGISTRATIONS

19 FDA

19 FDA

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filter Legal Name Reset all filters

19 All

01 1AMRYT GMBH

02 5Amryt Pharmaceuticals, Inc.

03 5Chiesi Farmaceutici S.p.A.

04 8Chiesi USA, Inc.

filter District Decision Reset all filters

19 All

01 9No Action Indicated

02 1Official Action Indicated

03 9Voluntary Action Indicated

filter Inspection End Date Reset all filters

19 All

01 12024-08-01

02 12023-09-29

03 12022-12-06

04 12022-09-14

05 12020-01-23

06 12018-11-23

07 12018-07-26

08 12018-06-15

09 12016-07-29

10 22015-07-16

11 12015-03-06

12 12015-03-04

13 12012-09-20

14 12012-08-27

15 12012-07-24

16 12011-07-08

17 12010-03-24

18 12009-04-28

filter City Reset all filters

19 All

01 5Boston

02 8Cary

03 1Niefern-Oschelbronn

04 5Parma

filter Country/Area Reset all filters

19 All

01 1Germany

02 5Italy

03 13U.S.A

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01

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2024-08-01

CHIESI USA INC

City : Cary

State : North Carolina

Country/Area : U.S.A

Zip : 27518

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-08-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2023-09-29

CHIESI USA INC

City : Parma

State :

Country/Area : Italy

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-09-29

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2022-12-06

Amryt Pharma

City : Niefern-Oschelbronn

State :

Country/Area : Germany

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-12-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2022-09-14

Amryt Pharma

City : Boston

State : Massachusetts

Country/Area : U.S.A

Zip : 2110

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2022-09-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2020-01-23

Amryt Pharma

City : Boston

State : Massachusetts

Country/Area : U.S.A

Zip : 2110

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2020-01-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2018-11-23

CHIESI USA INC

City : Parma

State :

Country/Area : Italy

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-11-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2018-07-26

CHIESI USA INC

City : Parma

State :

Country/Area : Italy

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-07-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2018-06-15

CHIESI USA INC

City : Cary

State : North Carolina

Country/Area : U.S.A

Zip : 27518

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2018-06-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2016-07-29

CHIESI USA INC

City : Parma

State :

Country/Area : Italy

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-07-29

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2015-07-16

Amryt Pharma

City : Boston

State : Massachusetts

Country/Area : U.S.A

Zip : 2110

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-07-16

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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