Pi Health Sciences | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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PI Health Sciences
FDA

Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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Smithfield BioScience transforms bioproducts into trusted, life-saving therapies through safe, reliable U.S.-based manufacturing.

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Evonik

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

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

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Temad- We think of world-class quality.

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PI Health Sciences

VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

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Webinars & Exhibitions

PRESENTATION(s)

Product List 2025

Product List 2025

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow

ACTIVE PHARMA INGREDIENTS

36 All APIs, 13 USDMF, 4 CEP/COS, 4 KDMF, 20 NDC API, 19 Listed APIs

36 All APIs
13 USDMF
4 CEP/COS
4 KDMF
20 NDC API
19 Listed APIs

INSPECTIONS & REGISTRATIONS

12 FDA, 3 GDUFA

12 FDA
3 GDUFA

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FILTER :

filter Legal Name Reset all filters

12 All

01 3Prime European Therapeuticals S.p.A., abbr Euticals S.p.A.

02 2Prime European Therapeuticals SPA

03 7Prime European Therapeuticals SpA dba Euticals SpA

filter District Decision Reset all filters

12 All

01 7No Action Indicated

02 5Voluntary Action Indicated

filter Inspection End Date Reset all filters

12 All

01 12017-04-28

02 12017-03-31

03 12015-07-17

04 12015-02-05

05 12014-09-25

06 12014-03-28

07 12012-11-23

08 12012-09-21

09 12011-09-15

10 12011-09-08

11 12010-05-13

12 12009-07-22

filter City Reset all filters

12 All

01 3Lodi

02 2Origgio

03 3Rozzano

04 2Rozzano (Mi)

05 2Varese

filter Country/Area Reset all filters

12 All

01 12Italy

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2017-04-28

City : Lodi

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-04-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2017-03-31

City : Rozzano

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-03-31

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2015-07-17

City : Varese

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-07-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2015-02-05

City : Rozzano (Mi)

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-02-05

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2014-09-25

City : Lodi

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-09-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2014-03-28

City : Origgio

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-03-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2012-11-23

City : Rozzano

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-11-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2012-09-21

City : Varese

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-09-21

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2011-09-15

City : Rozzano (Mi)

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2011-09-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

ACS Fall 2025

Not Confirmed

FDA Audited

USA

ACS Fall 2025

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 : 2011-09-08

City : Lodi

State :

Country/Area : Italy

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2011-09-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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