Promoted Content

Promoted Content

X

Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Minakem

Minakem

MINAKEM

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2021, Corporate Presentation, GMP Certificate 2022, API Product List 2021, 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, High Containment Lab

DIGITAL CONTENT

3 Interview #SpeakPharma, 3 Supplier #LearnMore, 53 News

APIs // Active Pharmaceutical Ingredients

17 APIs, 6 USDMF, 9 CEP/COS, 3 JDMF, 9 KDMF, 9 NDC API, 14 Listed APIs

DEVELOPMENTS

No Content

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

INTERMEDIATES

49 Listed Products

49 Listed Products

SERVICES

All Services, API Manufacturing, API & Drug Product Development

KEY SERVICES

High Potency API (HPAPI) Manufacturing, Continuous Flow Chemistry, Polymorph & Cocrystal Study, Development of High Potency APIs (HPAPIs), Fine Chemical and Intermediate Development, Custom Synthesis & Development

High Potency API (HPAPI) Manufacturing
Continuous Flow Chemistry
Polymorph & Cocrystal Study
Development of High Potency APIs (HPAPIs)
Fine Chemical and Intermediate Development
Custom Synthesis & Development

EXCIPIENTS

2 Listed Products

2 Listed Products

KEY EXCIPIENTS

Propyl Gallate GMP

Propyl Gallate GMP

EXCIPIENTS BY INGREDIENTS

Propyl Gallate, Sodium Stearyl Fumarate

EXCIPIENTS BY APPLICATIONS

API Stability Enhancers, Lubricants & Glidants

INSPECTIONS & REGISTRATIONS

13 FDA, 29 EDQM, 2 Others, 1 GDUFA

List of Products

Full View Screen

Full Screen View

Supplier Virtual Booth

price-trend

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Budesonide

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

Found USDMF

Application Number

28441

Status

Active

Filing Details

BUDESONIDE MICRONIZED

Issue/Submission Date

2014-06-20

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2010-190 - Rev 03

Status

Valid

Filing Details

Budesonide Micronised, non-micronis...

Issue/Submission Date

2020-06-09

Japanese DMF

Found JDMF

Application Number

301MF10045

Status

Filing Details

Budesonide at 224 avenue de la Dord...

Issue/Submission Date

2019-08-20

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

28441

R1-CEP 2010-190 - Rev 03

301MF10045

Status

Active
Fees Paid
Reviewed

Valid

Filing Details

BUDESONIDE MICRONIZED

Budesonide Micronised, non-micronis...

Budesonide at 224 avenue de la Dord...

Issue/Submission Date

2014-06-20

2020-06-09

2019-08-20

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Vinorelbine Tartrate

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

Found USDMF

Application Number

14619

Status

Active

Filing Details

VINORELBINE TARTRATE

Issue/Submission Date

1999-12-13

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2011-342 - Rev 00

Status

Valid

Filing Details

Vinorelbine tartrate

Issue/Submission Date

2018-08-06

Japanese DMF

Found JDMF

Application Number

303MF10150

Status

Filing Details

Vinorelbine Tartrate at Rue Fonds J...

Issue/Submission Date

2021-09-17

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

14619

R1-CEP 2011-342 - Rev 00

303MF10150

Status

Active
Fees Paid
Reviewed

Valid

Filing Details

VINORELBINE TARTRATE

Vinorelbine tartrate

Vinorelbine Tartrate at Rue Fonds J...

Issue/Submission Date

1999-12-13

2018-08-06

2021-09-17

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Esomeprazole Magnesium

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

Found USDMF

Application Number

28462

Status

Active

Filing Details

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Issue/Submission Date

2014-07-08

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2015-086 - Rev 00

Status

Valid

Filing Details

Esomeprazole magnesium dihydrate Mi...

Issue/Submission Date

2020-08-31

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

28462

R1-CEP 2015-086 - Rev 00

Status

Active
Fees Paid
N/A

Valid

Filing Details

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Esomeprazole magnesium dihydrate Mi...

Issue/Submission Date

2014-07-08

2020-08-31

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Esomeprazole Magnesium

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

Found USDMF

Application Number

34026

Status

Active

Filing Details

ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...

Issue/Submission Date

2019-10-04

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2012-256 - Rev 02

Status

Valid

Filing Details

Esomeprazole magnesium trihydrate M...

Issue/Submission Date

2021-06-03

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

34026

R1-CEP 2012-256 - Rev 02

Status

Active
Fees Paid
Reviewed

Valid

Filing Details

ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...

Esomeprazole magnesium trihydrate M...

Issue/Submission Date

2019-10-04

2021-06-03

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Vinblastine Sulfate

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

Found USDMF

Application Number

5335

Status

Active

Filing Details

VINBLASTINE SULFATE

Issue/Submission Date

1984-04-13

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2004-073 - Rev 02

Status

Valid

Filing Details

Vinblastine Sulfate

Issue/Submission Date

2015-08-04

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

5335

R1-CEP 2004-073 - Rev 02

Status

Active
Fees Paid
Reviewed

Valid

Filing Details

VINBLASTINE SULFATE

Vinblastine Sulfate

Issue/Submission Date

1984-04-13

2015-08-04

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Vincristine Sulfate

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

Found USDMF

Application Number

4932

Status

Active

Filing Details

VINCRISTINE SULFATE

Issue/Submission Date

1983-06-01

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2004-048 - Rev 04

Status

Valid

Filing Details

Vincristine sulfate

Issue/Submission Date

2020-01-29

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

4932

R1-CEP 2004-048 - Rev 04

Status

Active
Fees Paid
Reviewed

Valid

Filing Details

VINCRISTINE SULFATE

Vincristine sulfate

Issue/Submission Date

1983-06-01

2020-01-29

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Azaperone

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2013-013 - Rev 00

Status

Valid

Filing Details

Azaperone for veterinary use

Issue/Submission Date

2019-09-19

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

R1-CEP 2013-013 - Rev 00

Status

Valid

Filing Details

Azaperone for veterinary use

Issue/Submission Date

2019-09-19

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Remifentanil

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

Found CEP/COS

Application Number

R0-CEP 2020-323 - Rev 00

Status

Valid

Filing Details

Remifentanil hydrochloride

Issue/Submission Date

2022-03-14

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

R0-CEP 2020-323 - Rev 00

Status

Valid

Filing Details

Remifentanil hydrochloride

Issue/Submission Date

2022-03-14

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Vinblastine Sulfate

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

Found CEP/COS

Application Number

R0-CEP 2020-065 - Rev 00

Status

Valid

Filing Details

Vinblastine Sulfate Process 2

Issue/Submission Date

2020-09-09

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

R0-CEP 2020-065 - Rev 00

Status

Valid

Filing Details

Vinblastine Sulfate Process 2

Issue/Submission Date

2020-09-09

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Vindesine Sulfate

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

Found JDMF

Application Number

218MF10518

Status

Filing Details

Vindesine sulfate at Rue Fonds Jean...

Issue/Submission Date

2006-05-18

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

218MF10518

Status

Filing Details

Vindesine sulfate at Rue Fonds Jean...

Issue/Submission Date

2006-05-18

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Formoterol Fumarate

PDF Supplier PDF

URL Supplier Web Content

NA Not Available For Sales

See all info for this product

See Less

USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

Status

Filing Details

Issue/Submission Date

Minakem Comapny Banner

World ADC London 2023

Attending

envelop Contact Supplier

Minakem

Contact Supplier

CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Fulvestrant

PDF Supplier PDF

URL Supplier Web Content

See all info for this product

See Less

USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details