Drug Product
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
CCL Healthcare is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Australia
Founded:2019
Employees:2,038
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 5T81FR
EMA · #APR-F0JLJ38G · 2020-06-01
Drug Approval OEDLCK
EMA · #APR-UW45MPON · 2021-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-DCWDYDMS
Issued: 2020-03-26
Expires: 2025-06-05
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-AV5PI05R
Issued: 2020-10-02
Expires: 2025-04-28
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-NFPJACEE
Issued: 2020-04-16
Expires: 2025-04-24
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-VZ7ZUOWR
Issued: 2020-09-25
Expires: 2025-12-18
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Key facts about CCL Healthcare
- CCL Healthcare is headquartered in Australia.
- CCL Healthcare was founded in 2019.
- CCL Healthcare has 2,038 employees.
- CCL Healthcare's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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