Manufacturing Site
Charles City – API Site
Charles City, Iowa, USA
- Blocks
- 5
- Area
- 320,000 sq.ft
Classification
ISO 7 Clean RoomContainment Suite
Manufacturer ProfileAPINEXA Verified
Cambrex Corporation
Cambrex Corporation
US-based CDMO specializing in small-molecule API development & manufacturing with USFDA, EU GMP and DMF coverage across 6 dedicated sites.
- Headquarters
- East Rutherford, New Jersey, USA
- Established
- 1981 · 45 years
- Company Type
- API Manufacturer · CDMO
- Region
- New Jersey · Americas
Compliance Coverage
USFDAEU GMPDMFDEAISO 9001
Verification & Trust
Pre-qualified, Compliance-Reviewed Supplier
APINEXA verifies every manufacturer for compliance, regulatory documentation availability, and active export capability before listing.
APINEXA Verified
Confirmed
Verified since Apr 2024
Compliance Review
Cleared
Documentation reviewed by APINEXA team
Export Status
Active
Supplying 38 countries
Match Score
89
AI-derived sourcing confidence
Documentation Availability
Audit-grade documentation pack
- DMF AvailableDrug Master File on request via NDA
- CEP SupportEDQM Certificate of Suitability
- COA per BatchCertificate of Analysis with every shipment
- Stability DataICH Q1A long-term stability available
- Audit ReportRecent third-party audit findings
All Certifications
USFDA
USFDA Site Inspection
U.S. Food & Drug Administration
EU
EU GMP Certification
European Medicines Agency
DMF
US Drug Master File
USFDA
DEA
DEA Controlled Substance License
U.S. Drug Enforcement Administration
ISO
Quality Management
International Standards Org.
Company Overview
About Cambrex Corporation
Cambrex is a leading global Contract Development & Manufacturing Organization (CDMO) providing drug substance, drug product, and analytical services to innovator pharmaceutical companies. The company is known for complex small-molecule API development, custom synthesis, controlled-substance handling, and supports clients from clinical-phase through commercial supply.
Specialization
Custom SynthesisControlled SubstancesSmall-Molecule APIsHigh-Potency APIsInnovator CDMO
Core Strengths
Why buyers choose them
- Innovator-grade CDMO with full lifecycle service
- DEA-licensed controlled substance manufacturing
- HPAPI containment capability (OEB 4-5)
- US-based manufacturing for domestic supply chains
Manufacturing Capabilities
Operational strength
Production capacity, technology platforms, and clean-room infrastructure verified at the manufacturer source.
Production Capacity
Mid scale · 400 MT/yr
- Batch size
- 1 kg pilot · 2,500 kg commercial
- Annual capacity
- 400 MT/year aggregate
- Commercial scale
- Mid-scale commercial with CDMO flexibility
Facility Footprint
6 manufacturing sites
- Plants
- 6
- Manufacturing blocks
- 8 blocks
- Clean-room classes
- ISO 7 Clean Room · Containment Suite · ISO 8 Clean Room
Technology Capabilities
Process technology
- HPAPI handling (OEB 5)
- Controlled substance manufacturing
- Hydrogenation
- Chiral synthesis
- Flow chemistry
Product / API Portfolio
76+ APIs manufactured
A curated view of marquee molecules supplied by this manufacturer. Filter by therapeutic area to narrow results.
Regulatory Coverage
Export readiness across regulated markets
Authority-by-authority regulatory standing for major regulated and semi-regulated pharmaceutical markets.
Total Markets
4
Approved
3
Coverage
75%
| Region | Authority | Status |
|---|---|---|
United States | USFDA | Approved |
Europe | EU GMP | Approved |
Canada | Health Canada | Approved |
Japan | PMDA | Filed |
Export Markets
Active exports across 38 countries
Live supply footprint grouped by market regulatory class — Regulated, Semi-Regulated, and Emerging.
Regulated Markets
5- United States
- Canada
- Germany
- United Kingdom
- Switzerland
Semi-Regulated Markets
0No countries in this category.
Emerging Markets
0No countries in this category.
Export Statistics
38 countries · 5 highlighted
Active commercial exports across regulated markets, with documentation packs available per region.
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Facility & Infrastructure
Production sites & supporting infrastructure
Each facility is verified for clean-room class, production blocks, and built-up area.
Manufacturing Site
High Point – CDMO Site
High Point, North Carolina, USA
- Blocks
- 3
- Area
- 180,000 sq.ft
Classification
ISO 8 Clean Room
Supporting Infrastructure
R&D, QC, Warehousing & Stability
- Innovator-grade pilot plants
- DEA-secured controlled-substance vaults
- USFDA inspected analytical labs
- Continuous flow & containment suites
Supply Capabilities
Procurement decision support
MOQ flexibility, lead times, packaging formats, and supply-flexibility signals to support procurement teams.
MOQ & Lead Time
Order flexibility
- Minimum order quantity
- 100 g pilot · 25 kg commercial
- Lead time
- 8 – 16 weeks
- Contract manufacturing
- Supported
- Long-term supply
- Multi-year contracts
Packaging Options
Standard packaging formats
- Fibre drums with PE linerValidated packaging meeting export-grade requirements.
- Custom containment packagingValidated packaging meeting export-grade requirements.
- DEA-compliant sealed containersValidated packaging meeting export-grade requirements.
Certifications & Documents
Downloadable documentation pack
Secure document access. Restricted documents require an NDA submitted through the RFQ form.
RFQ / Supplier Contact
Contact Cambrex Corporation
Send a structured inquiry routed through APINEXA's coordination team — confidential, compliance-pre-checked, audit-grade. Typical response in 10 hours.