Alcami
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Drug Product
Analytical & Bioanalytical Services
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Manufacturing & Lab Equipment
Consultants & Advisory Services
Company Overview
About
Alcami is a US-based CDMO with 45+ years of experience providing integrated drug product manufacturing, laboratory services, and cGMP pharmaceutical storage. The company specializes in sterile fill-finish manufacturing (liquid and lyophilized injectables, prefilled syringes) and oral solid dose, with DEA licensing for controlled substances and EU/Annex 1 compliance.
Key Expertise
sterile fill-finish, lyophilization, oral solid dose, controlled substances, cGMP storage, clinical packaging, isolator technology, prefilled syringes
Quick Facts
HQ:United States
Founded:1979
Consulting Services
Alcami — Technical & Process
Drug Development & Formulation
Expertise
Pharmaceutical R&D
Biosimilars, Advanced Therapies
API synthesis optimization, and IND-enabling studies.
Formulation development
Analytical Development (method dev/validation, QC, stability study)
- Industry experience
- 47 years
- Engagement types
- consulting
Capabilities & Services
Core Capabilities
- Small Molecule Drug Product
- Oral Solid Dose
- Formulation Development
Dosage Forms
Oral Solid Dose
Sterile Injectable
Lyophilized (Freeze-Dried)
Prefilled Syringe
Containment Capabilities
DEA Schedule II-V
Production Scales
R&D / Pre-clinical
Phase I Clinical Trials
Phase II
Clinical
Phase III Clinical Trials
Commercial Scale
Annual Capacity
Medium Clinical (100 - 1,000 kg/year)
Commercial (1,000 - 10,000 kg/year)
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Alcami - United States Facility
United States
Site Capabilities
3 capabilitiesSolid Dose Manufacturing
Oral Liquids
Topicals
Certifications
FDA Registration
U.S. Food and Drug Administration
EMA GMP Certificate
European Medicines Agency