Isotopia Molecular Imaging Ltd
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Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Isotopia Molecular Imaging Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1996
Employees:1,003
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
Manufacturing Facilities
3 sites worldwide
ISOTOPIA MOLECULAR IMAGING LTD
39 Alexander Yanai, Segula Industrial Park, Petah Tikva, 4927735
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Isotopia Molecular Imaging
Soreq Nuclear Reseach Center (NRC), Yavne, 8180000
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
Isotopia Molecular Imaging
8 Hasatat, Modiin-maccabim-reut, 7178106
Site Capabilities
1 capabilityPACK
International Regulatory
EU GMP Certificates
16
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval MFC9ZD
PMDA · #APR-DPWZ8HP5 · 2022-06-01
Drug Approval 1W2NER
FDA · #APR-TOP559PY · 2020-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-5MQDMS6J
Issued: 2020-06-08
Expires: 2025-03-25
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-RGF1LHB2
Issued: 2020-08-21
Expires: 2025-03-11
WHO GMP
World Health Organization
Cert #: CERT-VEM046LN
Issued: 2020-09-07
Expires: 2025-11-25
Health Canada GMP
Health Canada
Cert #: CERT-ANY7KIVL
Issued: 2020-02-25
Expires: 2025-07-16
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Key facts about Isotopia Molecular Imaging Ltd
- Isotopia Molecular Imaging Ltd is headquartered in Germany.
- Isotopia Molecular Imaging Ltd was founded in 1996.
- Isotopia Molecular Imaging Ltd has 1,003 employees.
- Isotopia Molecular Imaging Ltd has 3 manufacturing sites listed on CDMO Hub, in Petah Tikva, Israel, Yavne, Israel and Modiin-maccabim-reut, Israel.
- Isotopia Molecular Imaging Ltd's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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