SKYEPHARMA (Skyepharma Productions SAS)
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Drug Product
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
SKYEPHARMA (Skyepharma Productions SAS) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:France
Founded:2006
Employees:1,809
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
SKYEPHARMA PRODUCTION SAS
ZONE INDUSTRIELLE CHESNES OUEST 55 RUE DU MONTMURIER, ST QUENTIN FALLAVIER, 38070
Site Capabilities
5 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
RELABEL
International Regulatory
EU GMP Certificates
3
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval YI0NOZ
EMA · #APR-O3RGUMQO · 2021-09-01
Drug Approval I43PCM
PMDA · #APR-WIAUFASD · 2019-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-TAJM0HOC
Issued: 2020-06-02
Expires: 2025-08-14
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-R4IAYIZR
Issued: 2020-06-11
Expires: 2025-02-07
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Key facts about SKYEPHARMA (Skyepharma Productions SAS)
- SKYEPHARMA (Skyepharma Productions SAS) is headquartered in France.
- SKYEPHARMA (Skyepharma Productions SAS) was founded in 2006.
- SKYEPHARMA (Skyepharma Productions SAS) has 1,809 employees.
- SKYEPHARMA (Skyepharma Productions SAS) has one manufacturing site listed on CDMO Hub, in ST QUENTIN FALLAVIER, France.
- SKYEPHARMA (Skyepharma Productions SAS)'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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