Drug Product
Company Overview
About
Antibiotice S.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Romania
Founded:2011
Employees:1,173
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Antibiotice SA
1 Valea Lupului Street, Iasi, Iasi, 707410
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
International Regulatory
EU GMP Certificates
4
WHO Prequalified Products
7
Regulatory Bodies
EMA/EudraGMDP
WHO
Regulatory Approvals
Drug Approval 6M9RFD
PMDA · #APR-HWNRP4T4 · 2018-09-01
Drug Approval 5EZ2ZQ
EMA · #APR-OX1ITITD · 2021-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-P0TL3EXW
Issued: 2020-02-06
Expires: 2025-03-04
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-17CM3UVM
Issued: 2020-07-27
Expires: 2025-06-14
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-5R59PI7H
Issued: 2020-06-21
Expires: 2025-09-14
WHO GMP
World Health Organization
Cert #: CERT-QTNMMI0Q
Issued: 2020-08-23
Expires: 2025-08-11
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Key facts about Antibiotice S.A.
- Antibiotice S.A. is headquartered in Romania.
- Antibiotice S.A. was founded in 2011.
- Antibiotice S.A. has 1,173 employees.
- Antibiotice S.A. has one manufacturing site listed on CDMO Hub, in Iasi, Romania.
- Antibiotice S.A.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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