Athena Pharmaceutiques Oral Dispersible Tablets

Athena Pharmaceutiques Oral Dispersible Tablets

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Details of Minakem's U.S. FDA Inspections. Original Data: FDA Inspection Database

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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, 58 News

APIs // Active Pharmaceutical Ingredients

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

DEVELOPMENTS

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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, Development of High Potency APIs (HPAPIs), Custom Synthesis & Development, Synthesis of Advanced Intermediates, Polymorph, Salt & Cocrystal Study

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

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

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District Decision

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Inspection End Date

2020-02-06

City

Corbais

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BE

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ORA

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CDER

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Drug Quality Assurance

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Inspection End Date

2018-06-22

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Dunkirk

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District Decision

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Inspection End Date

2018-01-25

City

Beuvry-la-foret

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FR

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ORA

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CDER

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Voluntary Action Indicated

Inspection End Date

2016-04-22

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Dunkirk

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CDER

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District Decision

Voluntary Action Indicated

Inspection End Date

2016-03-25

City

Beuvry-la-foret

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FR

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ORA

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CVM

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District Decision

Voluntary Action Indicated

Inspection End Date

2016-03-25

City

Beuvry-la-foret

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FR

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ORA

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CDER

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District Decision

No Action Indicated

Inspection End Date

2015-09-24

City

Corbais

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BE

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CDER

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District Decision

Voluntary Action Indicated

Inspection End Date

2013-09-13

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Beuvry-la-foret

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FR

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District Decision

Voluntary Action Indicated

Inspection End Date

2013-09-13

City

Beuvry-la-foret

State

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FR

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District

ORA

Center

CDER

Project Area

Drug Quality Assurance

Minakem Comapny Banner

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Minakem

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District Decision

No Action Indicated

Inspection End Date

2013-05-17

City

Dunkirk

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FR

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CDER

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Drug Quality Assurance

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

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District Decision

Voluntary Action Indicated

Inspection End Date

2012-01-12

City

Corbais

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BE

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CDER

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Drug Quality Assurance

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

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District Decision

Voluntary Action Indicated

Inspection End Date

2010-07-08

City

Beuvry-la-foret

State

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FR

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ORA

Center

CVM

Project Area

Monitoring of Marketed An...

Minakem Comapny Banner

DCAT Week 2023

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Minakem

Contact Supplier

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

INSPECTIONS & REGISTRATIONS

PDF Supplier PDF

URL Supplier Web Content

District Decision

Voluntary Action Indicated

Inspection End Date

2010-07-08

City

Beuvry-la-foret

State

Country/Area

FR

Zip

District

ORA

Center

CDER

Project Area

Drug Quality Assurance

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