Company profile for Microchem SRL

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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About

Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmaceutical industry.Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill.Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified.

CONTACT DETAILS

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Country
Country
Italy
Address
Address
Via Filippo Turati, 229017 Fiorenzuola d'Arda PC
Telephone
Telephone
+39 0523981130
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter
Contact Info
Others

Events

Webinars & Exhibitions

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CPhI North America

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Meeting

Digital content read-more

Explore the latest content creation from this company

CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/microchem-srl-party-content-77596.pdf

NEWS #PharmaBuzz

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https://www.munit.com/news/batch-record-a-pillar-of-transparency-and-quality/

PRESS RELEASE
10 May 2024

https://www.munit.com/news/quality-agreements-the-cornerstone-of-quality-and-transparency-at-microchem/

PRESS RELEASE
02 May 2024

https://www.munit.com/news/advanced-process-validation-strategies-microchem-s-commitment-to-compliance-and-quality/

PRESS RELEASE
19 Apr 2024

https://www.munit.com/news/new-frontiers-in-micronization-services-the-building-c-of-microchem/

PRESS RELEASE
10 Apr 2024

https://www.munit.com/news/integration-and-innovation-in-qa-and-regulatory-affairs/

PRESS RELEASE
05 Apr 2024

https://www.munit.com/news/deficiency-letters-microchem-s-approach-to-supporting-regulatory-compliance/

PRESS RELEASE
28 Mar 2024

Inspections and registrations

Check the inspections & registration from this company

FDA

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01

FDA Audited

USA

Microchem SRL

City : Fiorenzuola D\'Arda

State :

Country/Area : Italy

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-09-28

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02

FDA Audited

USA

Microchem SRL

City : Fiorenzuola D\'Arda

State :

Country/Area : Italy

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-03-22

Company Banner

03

FDA Audited

USA

Microchem SRL

City : Fiorenzuola D'Arda

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-04-02

Company Banner

04

FDA Audited

USA

Microchem SRL

City : Fiorenzuola D'Arda

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-07-13

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EDQM

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01

GMP Certified

EU

Microchem SRL

Type : GMP Certificates

Number : IT-API/93/H...

EudraGMDP Key : 169501

Country : Italy

Issue Date : 2024-05-08

Post Code :

NCA Ref : 109

City : Fiorenzuola D\'arda

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02

GMP Certified

EU

Microchem SRL

Type : GMP Certificates

Number : NBF/9/2024/...

EudraGMDP Key : 168302

Country : Italy

Issue Date : 2024-02-29

Post Code :

NCA Ref : 109

City : Fiorenzuola D\'arda

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03

GMP Certified

EU

Microchem SRL

Type : GMP Certificates

Number : IT-API/53/H...

EudraGMDP Key : 127742

Country : Italy

Issue Date : 2021-04-27

Post Code :

NCA Ref : 100140

City : FIORENZUOLA D\'ARDA

Company Banner

04

GMP Certified

EU

Microchem SRL

Type : GMP Certificates

Number : IT-API/53/H...

EudraGMDP Key : 127642

Country : Italy

Issue Date : 2021-04-27

Post Code :

NCA Ref : 100140

City : FIORENZUOLA D\'ARDA

Company Banner

05

GMP Certified

EU

Microchem SRL

Type : GMP Certificates

Number : IT-API/207/...

EudraGMDP Key : 51101

Country : Italy

Issue Date : 2018-11-26

Post Code :

NCA Ref : 100140

City : FIORENZUOLA D\'ARDA

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Others

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01

Inspected

RoW

Inspection : ISO 9001

About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...

Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmaceutical industry.Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill.Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified.

Country : Italy

Company Banner

02

Inspected

RoW

Inspection : ISO 14001

About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...

Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmaceutical industry.Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill.Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified.

Country : Italy

Company Banner

03

Inspected

RoW

Inspection : AIFA

About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...

Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmaceutical industry.Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill.Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified.

Country : Italy

Company Banner

04

Inspected

RoW

Inspection : PMDA

About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...

Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmaceutical industry.Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill.Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified.

Country : Italy

Company Banner

05

Inspected

RoW

Inspection : MFDS

About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...

Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmaceutical industry.Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced, processing skill.Microchem operates under a comprehensive Quality System to comply with all regulatory authorities and harmonized requirements. Microchem is GMP compliance and ISO Certified.

Country : Italy

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