American Injectables
Is this your company? Claim this profile
Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
American Injectables is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:United States
Founded:1997
Employees:1,364
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
American Injectables Inc.
15261 Telcom Drive, Brooksville, Florida, 34604
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval CEL6Y5
PMDA · #APR-30B3HZ71 · 2019-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-2E7BCWAJ
Issued: 2020-04-24
Expires: 2025-02-25
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-A1DKBHU7
Issued: 2020-11-12
Expires: 2025-11-23
WHO GMP
World Health Organization
Cert #: CERT-C9FT74GO
Issued: 2020-06-13
Expires: 2025-02-12
Health Canada GMP
Health Canada
Cert #: CERT-PYTH7GYL
Issued: 2020-07-05
Expires: 2025-05-14
Loading CDMO intelligence...
Key facts about American Injectables
- American Injectables is headquartered in the United States.
- American Injectables was founded in 1997.
- American Injectables has 1,364 employees.
- American Injectables has one manufacturing site listed on CDMO Hub, in Brooksville, United States.
- American Injectables's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
Find CDMOs like American Injectables
Directory pages this company appears in, each with the full list of matching manufacturers.