Excipients & Specialty Ingredients
Company Overview
About
IOI Oleo GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Germany
Founded:2018
Employees:533
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Manufacturing Facilities
1 site worldwide
IOI Oleo GmbH
Arthur-Imhausen-Str. 92, Witten, 58453
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval GHZ7M2
EMA · #APR-MVB4KLJI · 2020-11-01
Drug Approval LP7HMM
EMA · #APR-O8FZQ91O · 2022-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-RX1B4IK0
Issued: 2020-09-24
Expires: 2025-01-28
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-JGEOMOVX
Issued: 2020-02-22
Expires: 2025-06-19
WHO GMP
World Health Organization
Cert #: CERT-QVIYNRXL
Issued: 2020-04-18
Expires: 2025-03-03
Health Canada GMP
Health Canada
Cert #: CERT-QTY8S2BU
Issued: 2020-05-09
Expires: 2025-12-12
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Key facts about IOI Oleo GmbH
- IOI Oleo GmbH is headquartered in Germany.
- IOI Oleo GmbH was founded in 2018.
- IOI Oleo GmbH has 533 employees.
- IOI Oleo GmbH has one manufacturing site listed on CDMO Hub, in Witten, Germany.
- IOI Oleo GmbH's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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