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List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Minakem by EDQM. Original Data: EDQM Database

Minakem
Minakem (formerly Delmar Chemicals)
CEP/COS

Minakem-PSE

Minafin Group appoints Olivier Ubrich as CEO of Health Chemistry Division

05 Sep 2024

// PRESS RELEASE

The EDQM has validated updated CEP of Vinorelbine of Minakem, sole Mfg in Europe

25 Jun 2024

// PRESS RELEASE

Minakem Canada is manufacturing steroid APIs in a brand-new production unit

17 May 2024

// PRESS RELEASE

Data Compilation
#PharmaFlow

Minakem RM

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CPhI Worldwide, Milan

Booth #5A73

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envelop Contact Supplier

Latest Content by PharmaCompass

Minakem

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2024, Corporate Presentation, GMP Certificate 2023, Building Blocks & GMP Excipients 2021, CDMO for Custom APIs & HPAPIs, Analytical Services, A Word With Minakem Teknoscienze, Minakem Interview, Challenging Chemistry in Pharmaceutical Manufacturing

Product List 2024
Corporate Presentation
GMP Certificate 2023
Building Blocks & GMP Excipients 2021
CDMO for Custom APIs & HPAPIs
Analytical Services
A Word With Minakem Teknoscienze
Minakem Interview
Challenging Chemistry in Pharmaceutical Manufacturing

VIDEO(s)

Corporate Video, Your Highly Reliable CDMO Partner, Plant Based Food Developing New Ingredients by EcoXtract, High Containment Lab

Corporate Video
Your Highly Reliable CDMO Partner
Plant Based Food Developing New Ingredients by EcoXtract
High Containment Lab

DIGITAL CONTENT

3 INTERVIEW #SpeakPharma, 1 VLOG #PharmaReel, 13 CORPORATE CONTENT #SupplierSpotlight, 3 COMPANY BIO #AboutSupplier, 2 DATA COMPILATION #PharmaFlow, 65 NEWS #PharmaBuzz

3 INTERVIEW #SpeakPharma
1 VLOG #PharmaReel
13 CORPORATE CONTENT #SupplierSpotlight
3 COMPANY BIO #AboutSupplier
2 DATA COMPILATION #PharmaFlow
65 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

73 All APIs, 21 USDMF, 10 CEP/COS, 4 JDMF, 13 KDMF, 27 NDC API, 1 VMF, 67 Listed APIs

73 All APIs
21 USDMF
10 CEP/COS
4 JDMF
13 KDMF
27 NDC API
1 VMF
67 Listed APIs

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

49 ALL Intermediates

49 ALL Intermediates

KEY PRODUCTS

1,1-Cyclobutane Dicarboxylic Acid, Budesonide, Cyclobutane Carboxaldehyde, Cyclopropyl Methyl Bromide, Cyclopropyl Methyl Chloride, Esomeprazole Magnesium, Esomeprazole Sodium, Fulvestrant, Ibrutinib, Methyl (1R,2S,5S)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate HCl, Propyl Gallate, Remifentanil, Vinblastine Sulfate, Vincristine Sulfate, Vinorelbine Tartrate

1,1-Cyclobutane Dicarboxylic Acid
Budesonide
Cyclobutane Carboxaldehyde
Cyclopropyl Methyl Bromide
Cyclopropyl Methyl Chloride
Esomeprazole Magnesium
Esomeprazole Sodium
Fulvestrant
Ibrutinib
Methyl (1R,2S,5S)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate HCl
Propyl Gallate
Remifentanil
Vinblastine Sulfate
Vincristine Sulfate
Vinorelbine Tartrate

SERVICES

API Manufacturing, API & Drug Product Development

API Manufacturing
API & Drug Product Development
- 2 Preformulation & Material Science
- 9 API Development

KEY SERVICES

Continuous Flow Chemistry, Synthesis of Advanced Intermediates, Polymorph, Salt & Cocrystal Study, API Custom Synthesis, CDMO for High Potency APIs (HPAPIs), HPAPI Contract Manufacturing

Continuous Flow Chemistry
Synthesis of Advanced Intermediates
Polymorph, Salt & Cocrystal Study
API Custom Synthesis
CDMO for High Potency APIs (HPAPIs)
HPAPI Contract Manufacturing

EXCIPIENTS

2 Listed Products

2 Listed Products

KEY EXCIPIENTS

Propyl Gallate GMP

Propyl Gallate GMP

EXCIPIENTS BY INGREDIENTS

Sodium Stearyl Fumarate, Propyl Gallate

Sodium Stearyl Fumarate
Propyl Gallate

EXCIPIENTS BY APPLICATIONS

API Stability Enhancers, Lubricants & Glidants

API Stability Enhancers
Lubricants & Glidants

INSPECTIONS & REGISTRATIONS

15 FDA, 26 EDQM, 2 GDUFA, 2 Others

15 FDA
26 EDQM
2 GDUFA
2 Others

Xls

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FILTER :

filter Substance Reset all filters

10 All

01 1Azaperone for veterinary use

02 1Budesonide, Micronised, non-micronised

03 1Esomeprazole magnesium dihydrate, Micronised, non-micronised

04 1Esomeprazole magnesium trihydrate, Micronised, non-micronised

05 1Remifentanil hydrochloride

06 1Solifenacin succinate

07 1Vinblastine Sulfate

08 1Vinblastine Sulfate, Process 2

09 1Vincristine sulfate

10 1Vinorelbine tartrate

filter Certificate Holder Reset all filters

10 All

01 1DELMAR CHEMICALS INC. LaSalle CA

02 5MINAKEM Dunkerque FR

03 4MINAKEM HIGH POTENT Mont-Saint-Guibert BE

filter Country Reset all filters

10 All

01 1Canada

02 7France

03 2Gabon

filter Status Reset all filters

10 All

01 10Valid

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APIs
USDMF
CEP/COS
JDMF
KDMF
NDC API
Listed APIs

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Digital Content

Azaperone for veterinary use

Product
Web Link

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Certificate Holder

MINAKEM Dunkerque FR

Status

Valid

Certificate Number

R1-CEP 2013-013 - Rev 00

Type

Chemical

Issue Date

2019-09-19

End Date

Substance Number

1708

Minakem Comapny Banner

01

Azaperone for veterinary use

CPhI Worldwide, Milan

Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Contact Supplier

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Digital Content

Certificate Numbers : R1-CEP 2013-013 - Rev 00

Status : Valid

Issue Date : 2019-09-19

Type : Chemical

Substance Number : 1708

Minakem Comapny Banner

Product
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Minakem

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Digital Content

Budesonide, Micronised, non-micronised

Product
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Certificate Holder

MINAKEM Dunkerque FR

Status

Valid

Certificate Number

R1-CEP 2010-190 - Rev 03

Type

Chemical

Issue Date

2020-06-09

End Date

Substance Number

1075

Minakem Comapny Banner

02

Budesonide, Micronised, non-micronised

CPhI Worldwide, Milan

Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Digital Content

Certificate Numbers : R1-CEP 2010-190 - Rev 03

Status : Valid

Issue Date : 2020-06-09

Type : Chemical

Substance Number : 1075

Minakem Comapny Banner

Product
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Minakem

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Digital Content

Esomeprazole magnesium dihydrate, Micronised, non-micro...

Product
Web Link

Stock Recap
#PipelineProspector