Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Leukocare AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:2008
Employees:2,774
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 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Regulatory Approvals
Drug Approval LRVH6V
Health Canada · #APR-ODT79XSE · 2020-06-01
Drug Approval J51D91
PMDA · #APR-HE4G3JYK · 2021-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-DLFEKND1
Issued: 2020-10-26
Expires: 2025-03-02
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-83LJBKCC
Issued: 2020-12-16
Expires: 2025-01-03
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-EFKIN0DA
Issued: 2020-02-27
Expires: 2025-02-04
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-WJ014B39
Issued: 2020-02-02
Expires: 2025-11-12
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Key facts about Leukocare AG
- Leukocare AG is headquartered in Germany.
- Leukocare AG was founded in 2008.
- Leukocare AG has 2,774 employees.
- Leukocare AG's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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