Miltenyi Bioindustries (Miltenyi Biotec)
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Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Miltenyi Bioindustries (Miltenyi Biotec) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Germany
Founded:2012
Employees:2,771
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Miltenyi Biotec Gmbh
Friedrich-Ebert-Str. 68, Bergisch Gladbach
Regulatory Approvals
Drug Approval 458YL3
Health Canada · #APR-YBJ4GKFN · 2020-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-TPVQXNUK
Issued: 2020-11-09
Expires: 2025-09-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-XRYCA9RN
Issued: 2020-10-21
Expires: 2025-03-18
Health Canada GMP
Health Canada
Cert #: CERT-1ALVV29Z
Issued: 2020-08-27
Expires: 2025-11-18
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Key facts about Miltenyi Bioindustries (Miltenyi Biotec)
- Miltenyi Bioindustries (Miltenyi Biotec) is headquartered in Germany.
- Miltenyi Bioindustries (Miltenyi Biotec) was founded in 2012.
- Miltenyi Bioindustries (Miltenyi Biotec) has 2,771 employees.
- Miltenyi Bioindustries (Miltenyi Biotec) has one manufacturing site listed on CDMO Hub, in Bergisch Gladbach, Germany.
- Miltenyi Bioindustries (Miltenyi Biotec)'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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