Excipients & Specialty Ingredients
Company Overview
About
AB-BIOTICS S.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Neurology
Quick Facts
HQ:Spain
Founded:2010
Employees:2,566
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
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval ON1CRF
PMDA · #APR-8XCTC64X · 2022-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-HFTETY34
Issued: 2020-03-25
Expires: 2025-12-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-X2Y7B764
Issued: 2020-02-05
Expires: 2025-10-09
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-60WCT1JN
Issued: 2020-03-20
Expires: 2025-08-15
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-GFYX1TV0
Issued: 2020-09-01
Expires: 2025-05-10
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Key facts about AB-BIOTICS S.A.
- AB-BIOTICS S.A. is headquartered in Spain.
- AB-BIOTICS S.A. was founded in 2010.
- AB-BIOTICS S.A. has 2,566 employees.
- AB-BIOTICS S.A.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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