Zach System Sa | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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ZACH System SA
FDA

ZACH System-PSE

Zambon Announce First patient dosed in Ph 3b ADIP study of IPX203

22 Dec 2025

// PRESS RELEASE

Zambon appoints Franco Gaudino as Chief HR Officer

11 Sep 2025

// PRESS RELEASE

Zambon Launches Intravenous Formulation of Fluimucil

29 Jun 2025

// PRESS RELEASE

DATA COMPILATION
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Latest Content by PharmaCompass

https://www.youtube.com/embed/pnQL6oDh-KQ

ZACH System SA

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2024, Corporate Presentation, Results of Phase 3 PROMIS-I & PROMIS-II Studies 2023, GMP Certificate 2023, Pipeline, Zach Digital Brochure, Sophisticated Molecules

Product List 2024
Corporate Presentation
Results of Phase 3 PROMIS-I & PROMIS-II Studies 2023
GMP Certificate 2023
Pipeline
Zach Digital Brochure
Sophisticated Molecules

VIDEO(s)

Zambon Production Plant

Zambon Production Plant

DIGITAL CONTENT

8 Corporate Content #SupplierSpotlight, 43 News #PharmaBuzz

8 Corporate Content #SupplierSpotlight
43 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

4 All APIs, 2 USDMF, 3 KDMF, 1 NDC API, 3 Listed APIs

4 All APIs
2 USDMF
3 KDMF
1 NDC API
3 Listed APIs

KEY PRODUCTS

Bosentan Hydrate, Loteprednol Etabonate, Trimebutine Maleate

Bosentan Hydrate
Loteprednol Etabonate
Trimebutine Maleate

SERVICES

Analytical, API Manufacturing

Analytical
- 1 Analytical Method Development
API Manufacturing

KEY SERVICES

Spray Drying, Ozonolysis Reactions, Metal Hydride Reduction, Cyanation for API Custom Synthesis, Ultrafiltration & Nanofiltration

Spray Drying
Ozonolysis Reactions
Metal Hydride Reduction
Cyanation for API Custom Synthesis
Ultrafiltration & Nanofiltration

INSPECTIONS & REGISTRATIONS

5 FDA, 12 EDQM, 2 GDUFA

5 FDA
12 EDQM
2 GDUFA

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FILTER :

filter Legal Name Reset all filters

5 All

01 5Zach System S.A.

filter District Decision Reset all filters

5 All

01 2No Action Indicated

02 1Official Action Indicated

03 2Voluntary Action Indicated

filter Inspection End Date Reset all filters

5 All

01 12021-02-12

02 12017-12-07

03 12014-10-16

04 12010-12-02

05 12009-06-11

filter City Reset all filters

5 All

01 5Avrille Cedex

filter Country/Area Reset all filters

5 All

01 5France

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01

FDA Audited

USA

Biotech Outsourcing Strategies

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

District Decision : Voluntary Action Indicated

Inspection End Date : 2021-02-12

ZACH System SA

City : Avrille Cedex

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2021-02-12

Zach System VB Company banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Biotech Outsourcing Strategies

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-12-07

ZACH System SA

City : Avrille Cedex

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-12-07

Zach System VB Company banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Biotech Outsourcing Strategies

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

District Decision : No Action Indicated

Inspection End Date : 2014-10-16

ZACH System SA

City : Avrille Cedex

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-10-16

Zach System VB Company banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Biotech Outsourcing Strategies

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

District Decision : No Action Indicated

Inspection End Date : 2010-12-02

ZACH System SA

City : Avrille Cedex

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-12-02

Zach System VB Company banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

Biotech Outsourcing Strategies

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

District Decision : Official Action Indicated

Inspection End Date : 2009-06-11

ZACH System SA

City : Avrille Cedex

State :

Country/Area : France

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2009-06-11

Zach System VB Company banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

Contact Zach System Sa and get a quotation

Zach System Sa is a supplier offers 3 products (APIs, Excipients or Intermediates).

Find Bosentan Hydrate bulk with DMF offered by Zach System Sa

Find Loteprednol Etabonate bulk with DMF offered by Zach System Sa

Find Trimebutine Maleate bulk offered by Zach System Sa

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.