Manufacturing Site
Teva API – Sicor Site
Rho, Italy
- Blocks
- 7
- Area
- 240,000 sq.ft
Classification
ISO 5 Clean RoomSterile Block
Manufacturer ProfileAPINEXA Verified
Teva API
Teva Active Pharmaceutical Ingredients Division
Global API division of Teva Pharmaceuticals — one of the world's largest API portfolios with deep regulatory coverage and CDMO depth across 17 sites.
- Headquarters
- Petah Tikva, Israel
- Established
- 1935 · 91 years
- Company Type
- API Manufacturer · CDMO · Exporter
- Region
- Tel Aviv · EMEA
Compliance Coverage
USFDAEU GMPEDQMCEPDMFPMDA
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 Feb 2024
Compliance Review
Cleared
Documentation reviewed by APINEXA team
Export Status
Active
Supplying 168 countries
Match Score
95
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
EDQM
EDQM Compliance
European Directorate for the Quality of Medicines
CEP
Certificate of Suitability
EDQM
DMF
US Drug Master File
USFDA
PMDA
PMDA Approval
Pharmaceuticals & Medical Devices Agency, Japan
Company Overview
About Teva API
Teva API is the API division of Teva Pharmaceutical Industries, supplying APIs and intermediates to generic, branded and innovator pharmaceutical companies globally. With one of the broadest API portfolios in the industry and significant R&D investment, Teva API operates 17 manufacturing facilities across Europe, North America and Asia, all maintained under stringent USFDA, EU GMP and EDQM regulatory oversight.
Specialization
Generic API PortfolioCustom SynthesisPeptidesSterile APIsSteroids & Hormones
Core Strengths
Why buyers choose them
- One of the broadest API portfolios globally (312+)
- CDMO depth with end-to-end services
- Strong USFDA / EMA / EDQM compliance posture
- European manufacturing base for EU buyers
Manufacturing Capabilities
Operational strength
Production capacity, technology platforms, and clean-room infrastructure verified at the manufacturer source.
Production Capacity
Large scale · 2,000 MT/yr
- Batch size
- 1 kg pilot · 5,000 kg commercial
- Annual capacity
- 2,000+ MT/year aggregate
- Commercial scale
- Tier-1 multi-site commercial scale
Facility Footprint
17 manufacturing sites
- Plants
- 17
- Manufacturing blocks
- 18 blocks
- Clean-room classes
- ISO 5 Clean Room · Sterile Block · ISO 7 Clean Room · Containment Suite
Technology Capabilities
Process technology
- Peptide synthesis
- HPAPI handling (OEB 4-5)
- Sterile crystallization
- Continuous manufacturing
- Complex hormones
Product / API Portfolio
312+ APIs manufactured
A curated view of marquee molecules supplied by this manufacturer. Filter by therapeutic area to narrow results.
- Cardiovascular
Atorvastatin Calcium
CAS 134523-03-8
USDMFCEPEU GMPStrong SupplyVery HighView API profile - Diabetes / GLP-1
Semaglutide
CAS 910463-68-2
USDMFEU GMPLimited AvailabilityVery HighView API profile - Oncology
Lenalidomide
CAS 191732-72-6
USDMFEU GMPActive ExportVery HighView API profile - Cardiovascular
Rosuvastatin Calcium
CAS 147098-20-2
USDMFCEPStrong SupplyHighView API profile
Regulatory Coverage
Export readiness across regulated markets
Authority-by-authority regulatory standing for major regulated and semi-regulated pharmaceutical markets.
Total Markets
6
Approved
6
Coverage
100%
| Region | Authority | Status |
|---|---|---|
United States | USFDA | Approved |
Europe | EU GMP / EDQM | Approved |
Japan | PMDA | Approved |
Canada | Health Canada | Approved |
Australia | TGA | Approved |
Israel | MOH Israel | Approved |
Export Markets
Active exports across 168 countries
Live supply footprint grouped by market regulatory class — Regulated, Semi-Regulated, and Emerging.
Regulated Markets
8- United States
- Germany
- United Kingdom
- France
- Italy
- Japan
- Canada
- Australia
Semi-Regulated Markets
0No countries in this category.
Emerging Markets
0No countries in this category.
Export Statistics
168 countries · 8 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
Teva API – Plantex
Netanya, Israel
- Blocks
- 5
- Area
- 180,000 sq.ft
Classification
ISO 7 Clean RoomContainment Suite
Manufacturing Site
Teva API – Ramat Hovav
Beersheba, Israel
- Blocks
- 6
- Area
- 210,000 sq.ft
Classification
ISO 7 Clean Room
Supporting Infrastructure
R&D, QC, Warehousing & Stability
- Global R&D centres (Israel + Italy)
- USFDA & EMA inspected QC laboratories
- GLP-compliant stability storage
- Audit-grade documentation vault
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
- 1 kg pilot · 50 kg commercial
- Lead time
- 4 – 8 weeks
- Contract manufacturing
- Supported
- Long-term supply
- Multi-year contracts
Packaging Options
Standard packaging formats
- 25 kg fibre drumsValidated packaging meeting export-grade requirements.
- HDPE drums with PE linerValidated packaging meeting export-grade requirements.
- Custom sterile packagingValidated 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 Teva API
Send a structured inquiry routed through APINEXA's coordination team — confidential, compliance-pre-checked, audit-grade. Typical response in 6 hours.