Manufacturing Site
Chuannan – API Block A
Linhai, Zhejiang
- Blocks
- 6
- Area
- 120,000 sq.ft
Classification
ISO 7 Clean Room
Manufacturer ProfileAPINEXA Verified
Zhejiang Huahai Pharma
Zhejiang Huahai Pharmaceutical Co., Ltd.
Major Chinese API & finished-dosage manufacturer with USFDA, EU GMP and WHO GMP approvals — known for cardiovascular and CNS API portfolio.
- Headquarters
- Linhai, Zhejiang, China
- Established
- 1989 · 37 years
- Company Type
- API Manufacturer · Exporter · Finished Dosage Manufacturer
- Region
- Zhejiang · APAC
Compliance Coverage
USFDAEU GMPWHO GMPNMPADMF
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 Jul 2024
Compliance Review
Cleared
Documentation reviewed by APINEXA team
Export Status
Active
Supplying 84 countries
Match Score
88
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
WHO
WHO Good Manufacturing
World Health Organization
NMPA
NMPA Approval
National Medical Products Administration, China
DMF
US Drug Master File
USFDA
Company Overview
About Zhejiang Huahai Pharma
Zhejiang Huahai Pharmaceutical is a leading Chinese vertically integrated pharmaceutical company specialising in APIs, intermediates, and finished dosage forms. It is a top-tier supplier of cardiovascular APIs to global markets and operates USFDA, EU GMP and WHO GMP inspected facilities across multiple sites in Zhejiang.
Specialization
Cardiovascular APIsCNS APIsAnti-InfectivesSartans Portfolio
Core Strengths
Why buyers choose them
- Large-scale cardiovascular API capacity
- Vertically integrated KSM to finished dosage
- Cost-competitive commercial supply
- Strong NMPA & EMA inspection record
Manufacturing Capabilities
Operational strength
Production capacity, technology platforms, and clean-room infrastructure verified at the manufacturer source.
Production Capacity
Large scale · 1,500 MT/yr
- Batch size
- 100 kg – 10,000 kg per batch
- Annual capacity
- 1,500 MT/year aggregate
- Commercial scale
- Very large commercial scale (Tier-1)
Facility Footprint
6 manufacturing sites
- Plants
- 6
- Manufacturing blocks
- 10 blocks
- Clean-room classes
- ISO 7 Clean Room · ISO 8 Clean Room
Technology Capabilities
Process technology
- Continuous manufacturing
- Crystallization expertise
- Nitrosamine impurity controls
- Solid-state characterization
Product / API Portfolio
96+ 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
5
Approved
4
Coverage
80%
| Region | Authority | Status |
|---|---|---|
United States | USFDA | Approved |
Europe | EU GMP | Approved |
China | NMPA | Approved |
Japan | PMDA | Filed |
Brazil | ANVISA | Approved |
Export Markets
Active exports across 84 countries
Live supply footprint grouped by market regulatory class — Regulated, Semi-Regulated, and Emerging.
Regulated Markets
3- United States
- Germany
- United Kingdom
Semi-Regulated Markets
2- Brazil
- Russia
Emerging Markets
0No countries in this category.
Export Statistics
84 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
Xunqiao – Cardiovascular APIs
Linhai, Zhejiang
- Blocks
- 4
- Area
- 85,000 sq.ft
Classification
ISO 8 Clean Room
Supporting Infrastructure
R&D, QC, Warehousing & Stability
- Centralised R&D centre
- USFDA inspected QC laboratories
- Nitrosamine impurity testing labs
- Validated solvent recovery system
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
- 25 kg pilot · 500 kg commercial
- Lead time
- 6 – 12 weeks
- Contract manufacturing
- Supported
- Long-term supply
- Multi-year contracts
Packaging Options
Standard packaging formats
- 25 kg HDPE drumsValidated packaging meeting export-grade requirements.
- Aluminium bagsValidated packaging meeting export-grade requirements.
RFQ / Supplier Contact
Contact Zhejiang Huahai Pharma
Send a structured inquiry routed through APINEXA's coordination team — confidential, compliance-pre-checked, audit-grade. Typical response in 12 hours.