AB Biotechnology Ltd
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Drug Product
Advanced Modalities
Company Overview
About
AB Biotechnology Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:United Kingdom
Founded:2008
Employees:2,768
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
Phase II
Clinical
Pilot Scale
Markets Served
Global
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 6RNRB1
PMDA · #APR-1ZVQMDCH · 2021-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-K5KVFMG2
Issued: 2020-05-18
Expires: 2025-07-09
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-8LV63YDP
Issued: 2020-02-13
Expires: 2025-09-15
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-72E08Z83
Issued: 2020-03-03
Expires: 2025-06-27
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Key facts about AB Biotechnology Ltd
- AB Biotechnology Ltd is headquartered in the United Kingdom.
- AB Biotechnology Ltd was founded in 2008.
- AB Biotechnology Ltd has 2,768 employees.
- AB Biotechnology Ltd's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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