Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
IDT Biologika is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Neurology
Quick Facts
HQ:Germany
Founded:2000
Employees:1,700
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
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
IDT Biologika GmbH
Am Pharmapark, Dessau-Rosslau, Saxony-Anhalt, 06861
Site Capabilities
6 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
STERILIZE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval DEG3ZL
PMDA · #APR-8LPHP8U0 · 2021-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-GGK4R5J5
Issued: 2020-04-09
Expires: 2025-08-19
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-PI630KKQ
Issued: 2020-09-11
Expires: 2025-10-05
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Key facts about IDT Biologika
- IDT Biologika is headquartered in Germany.
- IDT Biologika was founded in 2000.
- IDT Biologika has 1,700 employees.
- IDT Biologika has one manufacturing site listed on CDMO Hub, in Dessau-Rosslau, Germany.
- IDT Biologika's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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