Drug Product
Analytical & Bioanalytical Services
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
Alcami is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:1997
Employees:2,606
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
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Manufacturing Facilities
2 sites worldwide
Alcami Corporation
165 Fieldcrest Ave, Edison, New Jersey, 08837
Alcami Carolinas Corporation
4221 Faber Place Drive, Charleston, South Carolina, 29405
Site Capabilities
2 capabilitiesANALYSIS
MANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval G196MY
EMA · #APR-KESBRF1X · 2020-11-01
Drug Approval VXWP0M
FDA · #APR-LYXAEQPG · 2019-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SIA2Z2K9
Issued: 2020-05-10
Expires: 2025-02-21
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EUJU5PMO
Issued: 2020-08-21
Expires: 2025-11-05
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-VFEHLQX4
Issued: 2020-04-16
Expires: 2025-06-08
Health Canada GMP
Health Canada
Cert #: CERT-G5TDSAU7
Issued: 2020-02-11
Expires: 2025-07-17
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Key facts about Alcami
- Alcami is headquartered in the United States.
- Alcami was founded in 1997.
- Alcami has 2,606 employees.
- Alcami has 2 manufacturing sites listed on CDMO Hub, in Edison, United States and Charleston, United States.
- Alcami's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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