Luye Pharma (EU CDMO)
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Luye Pharma (EU CDMO) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:China
Founded:1992
Employees:791
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
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval EDSR4I
Health Canada · #APR-8LACFPHM · 2022-11-01
Drug Approval 4SJ7W1
EMA · #APR-DDT0B00I · 2022-04-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-6WP734LV
Issued: 2020-09-16
Expires: 2025-03-11
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-KBROQ4K0
Issued: 2020-08-09
Expires: 2025-10-26
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-GEKM7I2N
Issued: 2020-12-12
Expires: 2025-09-07
Health Canada GMP
Health Canada
Cert #: CERT-GNJGAFH1
Issued: 2020-06-14
Expires: 2025-06-26
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Key facts about Luye Pharma (EU CDMO)
- Luye Pharma (EU CDMO) is headquartered in China.
- Luye Pharma (EU CDMO) was founded in 1992.
- Luye Pharma (EU CDMO) has 791 employees.
- Luye Pharma (EU CDMO)'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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