Drug Product
Company Overview
About
Chiracon GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:2010
Employees:585
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Chiracon GmbH
Im Biotechnologiepark, Luckenwalde, 14943
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 6YSRUQ
PMDA · #APR-6D2T690Y · 2020-01-01
Drug Approval AAKJX0
PMDA · #APR-EY3UPO51 · 2020-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-N81NPHM6
Issued: 2020-01-10
Expires: 2025-01-05
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-89LSWQ82
Issued: 2020-09-11
Expires: 2025-05-01
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-UU8ZXVR2
Issued: 2020-05-21
Expires: 2025-10-05
Health Canada GMP
Health Canada
Cert #: CERT-SYCVA1QB
Issued: 2020-02-06
Expires: 2025-07-23
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Key facts about Chiracon GmbH
- Chiracon GmbH is headquartered in Germany.
- Chiracon GmbH was founded in 2010.
- Chiracon GmbH has 585 employees.
- Chiracon GmbH has one manufacturing site listed on CDMO Hub, in Luckenwalde, Germany.
- Chiracon GmbH's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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