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

Skyepharma
Vectura Ltd
FDA

Skyepharma-PSE

Bigger Thinking for nanomedicines 28 March 2023

28 Mar 2024

// PRESS RELEASE

Skyepharma: the specialized CDMO growing in double digits

24 Jan 2024

// PRESS RELEASE

Skyepharma CDMO makes debut at Nordic Life Science Days

23 Nov 2023

// PHARMACEUTICAL-TECHNOLOGY

Data Compilation
#PharmaFlow

Skyepharma RM

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CPhI Worldwide, Milan

Booth #18D8

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envelop Contact Supplier

Latest Content by PharmaCompass

Skyepharma

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)

Corporate Presentation, Controlling Lag-time & Release Kinetics of Press-coated Tablets , Microfluidization - Skyepharma Collaboration with Lyon University, GMP Certificate 2021, Leading Pharmaceutical Development in a Sustainable Way, Skyepharma & MaaT Pharma launches a facility for Biotherapies, Services, Quality By Design & Expertise, Compaction Simulation Expertise

Corporate Presentation
Controlling Lag-time & Release Kinetics of Press-coated Tablets
Microfluidization - Skyepharma Collaboration with Lyon University
GMP Certificate 2021
Leading Pharmaceutical Development in a Sustainable Way
Skyepharma & MaaT Pharma launches a facility for Biotherapies
Services
Quality By Design & Expertise
Compaction Simulation Expertise

VIDEO(s)

CDMO Expert in Complex Oral Solid Dosage Forms, Interview CPhI WW 2022, Services Presentation, Corporate Video - Center of Excellence, Agile CDMO Partner, Fully Integrated CDMO, Manufacturing Capabilities, Microfluidizer Technology, Pharmaceutical Development Services, Reliable CDMO Partner, Soctec® Technology, Pharmapack 2020- Interview with David Lescuyer, Packaging Services 2020, CPhI Worldwide 2018

CDMO Expert in Complex Oral Solid Dosage Forms
Interview CPhI WW 2022
Services Presentation
Corporate Video - Center of Excellence
Agile CDMO Partner
Fully Integrated CDMO
Manufacturing Capabilities
Microfluidizer Technology
Pharmaceutical Development Services
Reliable CDMO Partner
Soctec® Technology
Pharmapack 2020- Interview with David Lescuyer
Packaging Services 2020
CPhI Worldwide 2018

DIGITAL CONTENT

2 INTERVIEW #SpeakPharma, 23 CORPORATE CONTENT #SupplierSpotlight, 55 NEWS #PharmaBuzz

2 INTERVIEW #SpeakPharma
23 CORPORATE CONTENT #SupplierSpotlight
55 NEWS #PharmaBuzz

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers, 3 FDA Orange Book

3 FDF Dossiers
3 FDA Orange Book

SERVICES

Analytical, Drug Product Manufacturing, Sales, Marketing, Registration, Packaging, API & Drug Product Development

Analytical
- 1 Analytical Method Development
Drug Product Manufacturing
Sales, Marketing, Registration
- 1 Regulatory Affairs / Pharmacovigilance
Packaging
- 4 Contract Services
API & Drug Product Development
- 5 Formulation Development

KEY SERVICES

Modified Release Capsule Manufacturing, GEOMATRIX - Multi-layer Tablet Technology, GEOCLOCK - Press-coated Tablet (Tab-in-Tab), SOCTEC - ER Gastro-retentive Technology, Immediate & Modified Release Tablets, Controlled Drug Delivery, Highly Potent Tablet Manufacturing, Complex OSD Manufacturing, Orally Disintegrating Tablet Manufacturing, Chewable Tablet Manufacturing, Bioproduction, Highly Potent Capsule Manufacturing

Modified Release Capsule Manufacturing
GEOMATRIX - Multi-layer Tablet Technology
GEOCLOCK - Press-coated Tablet (Tab-in-Tab)
SOCTEC - ER Gastro-retentive Technology
Immediate & Modified Release Tablets
Controlled Drug Delivery
Highly Potent Tablet Manufacturing
Complex OSD Manufacturing
Orally Disintegrating Tablet Manufacturing
Chewable Tablet Manufacturing
Bioproduction
Highly Potent Capsule Manufacturing

INSPECTIONS & REGISTRATIONS

5 FDA, 5 EDQM, 1 GDUFA

5 FDA
5 EDQM
1 GDUFA

Xls

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FILTER :

filter Legal Name Reset all filters

5 All

01 1SkyePharma AG

02 4SkyePharma Production SAS

filter District Decision Reset all filters

5 All

01 4No Action Indicated

02 1Voluntary Action Indicated

filter Inspection End Date Reset all filters

5 All

01 12019-09-06

02 12015-06-19

03 12013-05-31

04 12010-04-02

05 12009-09-18

filter City Reset all filters

5 All

01 1Muttenz

02 4St Quentin Fallavier

filter Country/Area Reset all filters

5 All

01 1CH

02 4FR

FDA
EDQM
GDUFA

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

CPhI Worldwide, Milan

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

District Decision : No Action Indicated

Inspection End Date : 2009-09-18

City : Muttenz

State :

Country/Area : CH

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-09-18

Skyepharma Company Banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

CPhI Worldwide, Milan

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-04-02

City : St Quentin Fallavier

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-04-02

Skyepharma Company Banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

CPhI Worldwide, Milan

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

District Decision : No Action Indicated

Inspection End Date : 2013-05-31

City : St Quentin Fallavier

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-05-31

Skyepharma Company Banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

CPhI Worldwide, Milan

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

District Decision : No Action Indicated

Inspection End Date : 2015-06-19

City : St Quentin Fallavier

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-06-19

Skyepharma Company Banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

CPhI Worldwide, Milan

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

District Decision : No Action Indicated

Inspection End Date : 2019-09-06

City : St Quentin Fallavier

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2019-09-06

Skyepharma Company Banner

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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