Drug Product
Company Overview
About
Axyntis is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Neurology
Quick Facts
HQ:France
Founded:1997
Employees:1,113
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Orgapharm
ZONE INDUSTRIELLE RUE DU MOULIN DE LA CANNE, PITHIVIERS, 45300
Site Capabilities
2 capabilitiesAPI MANUFACTURE
MANUFACTURE
Regulatory Approvals
Drug Approval ZYUQJ5
Health Canada · #APR-UKXOUYVJ · 2022-10-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-G5SEUJIH
Issued: 2020-05-22
Expires: 2025-11-04
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-IYO4AMGN
Issued: 2020-06-10
Expires: 2025-01-25
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Key facts about Axyntis
- Axyntis is headquartered in France.
- Axyntis was founded in 1997.
- Axyntis has 1,113 employees.
- Axyntis has one manufacturing site listed on CDMO Hub, in PITHIVIERS, France.
- Axyntis's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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