AmericanBio, Inc.
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Drug Product
Excipients & Specialty Ingredients
Company Overview
About
AmericanBio, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:1995
Employees:2,661
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 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
Regulatory Approvals
Drug Approval NGIJJ7
FDA · #APR-1ZR2MH31 · 2019-03-01
Drug Approval R2PC0K
PMDA · #APR-VB912QSD · 2022-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-1XD49IMQ
Issued: 2020-07-10
Expires: 2025-01-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-3SHH1QLD
Issued: 2020-03-27
Expires: 2025-06-21
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-MFZ78QOJ
Issued: 2020-03-21
Expires: 2025-01-18
Health Canada GMP
Health Canada
Cert #: CERT-VPZHTTU2
Issued: 2020-11-11
Expires: 2025-05-08
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Key facts about AmericanBio, Inc.
- AmericanBio, Inc. is headquartered in the United States.
- AmericanBio, Inc. was founded in 1995.
- AmericanBio, Inc. has 2,661 employees.
- AmericanBio, Inc.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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