Hyaluronic Acid 9004-61-9 — China API Manufacturer | EP USP ChP R&D to Production

China Manufacturing Landscape for Hyaluronic Acid

Hyaluronic Acid (CAS 9004-61-9), also known as Sodium Hyaluronate in its salt form, is a naturally occurring glycosaminoglycan with extraordinary water-binding properties, making it indispensable across pharmaceutical, cosmetic, medical device, and nutraceutical applications. China has become the world’s largest producer of Hyaluronic Acid through microbial fermentation, with production capacity exceeding global demand. Our production facility is a leading manufacturer offering pharmaceutical, cosmetic, food, and medical-grade Hyaluronic Acid in a complete range of molecular weight grades to customers worldwide.

The Chinese Hyaluronic Acid industry has undergone rapid advancement, transitioning from animal-sourced extraction to sophisticated microbial fermentation technology that delivers higher purity, consistent molecular weight, and freedom from animal-derived contaminants. Our facility uses proprietary fermentation strains and optimized bioprocesses to produce HA across the full molecular weight spectrum, from ultra-low molecular weight oligomers to high molecular weight polymers exceeding 2 million Daltons.

Manufacturing Process & Facility Overview

Hyaluronic Acid production at our facility employs microbial fermentation using a non-pathogenic, non-GMO strain of Streptococcus zooepidemicus. The fermentation process is conducted in stainless steel bioreactors with volumes up to 50,000L, with automated control of dissolved oxygen, pH, temperature, agitation, and nutrient feeding to maximize HA yield and target specific molecular weight profiles. Post-fermentation processing includes cell removal by microfiltration, purification through multiple chromatographic and ultrafiltration steps, ethanol precipitation for molecular weight fractionation, and controlled lyophilization or spray drying for final product form.

The manufacturing facility features dedicated areas for different product grades (pharmaceutical, cosmetic, food) with independent HVAC systems and appropriate cleanroom classifications. Pharmaceutical-grade production operates under ISO Class 7 conditions. The facility includes advanced molecular weight characterization capability using multi-angle laser light scattering (MALLS) coupled with size-exclusion chromatography for precise molecular weight determination and distribution analysis.

Quality Standards & Multi-Pharmacopeial Compliance

Our Hyaluronic Acid products are manufactured and tested in compliance with European Pharmacopoeia (EP) Sodium Hyaluronate monograph, United States Pharmacopeia (USP), and Chinese Pharmacopoeia (ChP) specifications. Quality control testing encompasses glucuronic acid content determination (assay ≥95.0% on dried basis), intrinsic viscosity measurement for molecular weight characterization, protein content by Bradford or UV methods, nucleic acid content, endotoxin testing by LAL method, heavy metals by ICP-MS, microbial limit testing, and molecular weight distribution by SEC-MALLS.

Multiple grades are available to meet diverse application requirements: high molecular weight (1.5-2.5 MDa) for viscoelastic formulations, medium molecular weight (0.5-1.5 MDa) for topical and cosmetic applications, low molecular weight (100-500 kDa) for enhanced skin penetration, and ultra-low molecular weight (below 10 kDa) for nutraceutical and specialty applications. Each grade is produced under validated conditions with defined molecular weight specifications.

Regulatory Documentation & Export Support

We maintain complete regulatory documentation supporting Hyaluronic Acid applications across pharmaceutical, cosmetic, medical device, and food supplement categories. Available documentation includes US FDA Drug Master File (DMF), EDQM Certificate of Suitability (CEP), non-animal origin certification, non-GMO declarations, kosher and halal certifications, EU cosmetics regulation compliance data (CPNP ready), and Novel Food authorization documentation for EU food supplement applications.

Our regulatory team provides expert guidance on grade selection for specific end-use applications and supports customer regulatory filings with complete technical dossiers. We maintain ISO 13485 certification for medical-grade Hyaluronic Acid production and ISO 22716 (cosmetic quality standard) for cosmetic-grade material.

Packaging & Global Logistics

Hyaluronic Acid is available in lyophilized powder and spray-dried powder forms, packaged in double-layer polyethylene bags within aluminum-lined fiber drums. Standard packaging units include 100 g, 500 g, 1 kg, 5 kg, and 25 kg configurations. Pharmaceutical-grade material is packaged under controlled cleanroom conditions with nitrogen overlay. All packaging carries complete lot traceability, and certificates of analysis are provided with each shipment.

Global shipping is coordinated through established logistics channels with options for FOB, CIF, and DDP terms. Hyaluronic Acid is classified as non-hazardous for transport, enabling straightforward shipping logistics. Standard ocean freight delivery times are 18-25 days to European ports and 20-30 days to North American destinations. Air freight delivery is available within 3-5 business days globally.

Competitive Pricing & Supply Reliability

As one of China’s largest Hyaluronic Acid producers with substantial fermentation capacity, we offer competitive pricing that represents the most competitive sourcing option globally for high-quality HA. Our pricing structure accommodates all customer scales, from research quantities to multi-ton commercial orders, with attractive volume-based discounts and annual contract pricing options. Different grade and molecular weight specifications are priced to reflect production complexity while maintaining overall cost competitiveness.

Supply reliability is underpinned by continuous year-round fermentation capability, maintained finished goods inventory across all standard grades, and established backup fermentation capacity for demand surge management. Our on-time delivery performance exceeds 98%, and we provide dedicated key account management with proactive inventory planning support for major customers.

Hyaluronic Acid Technical Specifications