Altruist Biologics
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Drug Product
Advanced Modalities
Regulatory, Tech Transfer & Support Services
Company Overview
About
Altruist Biologics is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:China
Founded:1997
Employees:2,190
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
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval 5F0YQC
FDA · #APR-TBE62DJQ · 2021-12-01
Drug Approval VW4AER
PMDA · #APR-SE5KU7Y1 · 2018-04-01
Certifications
WHO GMP
World Health Organization
Cert #: CERT-LI53M4ZN
Issued: 2020-08-18
Expires: 2025-04-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-ND9IPFR4
Issued: 2020-04-26
Expires: 2025-12-24
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-CJN1076K
Issued: 2020-03-09
Expires: 2025-03-04
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-TGCA1SJ1
Issued: 2020-09-07
Expires: 2025-12-07
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Key facts about Altruist Biologics
- Altruist Biologics is headquartered in China.
- Altruist Biologics was founded in 1997.
- Altruist Biologics has 2,190 employees.
- Altruist Biologics's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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