FDA APPLICATION 21350 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Skyepharma

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Skyepharma

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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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, 56 NEWS #PharmaBuzz

2 INTERVIEW #SpeakPharma
23 CORPORATE CONTENT #SupplierSpotlight
56 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

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FILTER :

filter Applicant Reset all filters

2 All

01 2SKYEPHARMA AG

filter Dosage Reset all filters

2 All

01 2TABLET;ORAL

filter Regulatory Info Reset all filters

2 All

01 1DISCN

02 1RX

filter Brand Name Reset all filters

2 All

01 2TRIGLIDE

filter RLD Reset all filters

2 All

01 1No

02 1Yes

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Brand Name : TRIGLIDE

Pharma, Lab & Chemical Expo

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

Contact Supplier

Contact Supplier

Digital Content

RLD : No

TE Code :

FENOFIBRATE

Dosage Form : TABLET; ORAL

Proprietary Name : TRIGLIDE

Dosage Strength : 50MG

Approval Date : 2005-05-07

Application Number : 21350

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Brand Name : TRIGLIDE

Pharma, Lab & Chemical Expo

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

Contact Supplier

Contact Supplier

Digital Content

RLD : Yes

TE Code : BX

FENOFIBRATE

Dosage Form : TABLET; ORAL

Proprietary Name : TRIGLIDE

Dosage Strength : 160MG

Approval Date : 2005-05-07

Application Number : 21350

RX/OTC/DISCN : RX

RLD : Yes

TE Code : BX

Skyepharma Company Banner

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