Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Leanbio is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Neurology
Quick Facts
HQ:Spain
Founded:1990
Employees:196
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
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval 70QU2H
FDA · #APR-VJOR1GHA · 2019-03-01
Drug Approval ZB4BNO
PMDA · #APR-VJA8FDJ1 · 2020-11-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-NGG77N41
Issued: 2020-08-26
Expires: 2025-10-23
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-TCTWCAKX
Issued: 2020-04-06
Expires: 2025-02-26
Health Canada GMP
Health Canada
Cert #: CERT-0H6BKX45
Issued: 2020-07-09
Expires: 2025-02-07
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Key facts about Leanbio
- Leanbio is headquartered in Spain.
- Leanbio was founded in 1990.
- Leanbio has 196 employees.
- Leanbio's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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