KEYNOVO BIOTECH
CEP-Certified Polysaccharide APIs & Excipients
Specialised Polysaccharide API Partner
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Established Pharmaceutical
Ingredient Supplier
Experience & Expertise
Extensive experience in polysaccharide API manufacturing with a
proven track record in pharmaceutical-grade ingredient production.
Global Supply Capability
Long-term supply partnerships with pharmaceutical manufacturers
worldwide, supported by robust logistics and quality systems.
Regulatory Support
The professional regulatory affairs team provides comprehensive
documentation and technical support for customer registrations.
Why Choose Us as Your API Partner
1. CEP Maintenance Excellence
Robust CEP maintenance capability with systematic variation management and proactive regulatory communication.
2. EU Registration Support
Proven experience supporting pharmaceutical companies through EU registration processes with comprehensive technical dossiers.
3. Audit-Ready Systems
Fully compliant quality management system prepared for customer and regulatory audits at anytime.
4. Flexible & Reliable
Flexible minimum order quantities to support clinical and commercial requirements
Stable supply chain with strategic inventory management
Dedicated regulatory affairs specialists for ongoing support
Long-term partnership approach with technical collaboration
Manufacturing Capabilities
Advanced Production Systems
State-of-the-art fermentation technology with precise
environmental control ensures consistent product quality and optimal yields for polysaccharide APIs.
Automated fermentation process control
Multi-stage purification systems
Cleanroom production environment
Scalable & Quality-Focused
Our manufacturing infrastructure supports both clinical and
commercial production requirements with validated processes
and comprehensive quality oversight.
Capacity: Scalable production from pilot batches to
commercial volumes while maintaining pharmaceutical quality
standards throughout.
Quality Control System
Comprehensive Analytical Capabilities
Advanced Analytical Instrumentation
HPLC, GC, and ICP-MS systems for comprehensive chemical and elemental analysis.
ICH Stability Programmes
Comprehensive stability testing according to ICH guidelines with long-term and accelerated studies.
Batch Traceability
Complete traceability from raw materials through finished product with electronic batch records.
Method Validation
All analytical methods validated according to ICH Q2(R1) guidelines ensuring reliable and reproducible results.
Our quality control laboratory operates under GMP principles with qualified personnel and regularly calibrated equipment toensure data integrity and regulatory compliance.
Compliance & Certifications
Comprehensive regulatory compliance supporting pharmaceutical manufacturing worldwide.
Additional Certifications
Halal and Kosher certification available for applicable products
Complete documentation package including COA, COC, TSE/BSE
statements
Regulatory Support
Full technical dossiers, stability data, and regulatory support documentation provided to facilitate customer registrations.
Global Market Experience
International Client Base
Extensive experience supplying pharmaceutical-grade ingredients to manufacturers across Europe, North America, and the Asia-Pacific regions.
Our global supply network ensures reliable delivery and consistent quality regardless of destination, supported by comprehensive logistics expertise.
Regulatory Expertise
In-depth familiarity with regulatory requirements in major
pharmaceutical markets including EU EMA, US FDA, and other
international regulatory frameworks.
Customer Registration Support:
We provide comprehensive technical support for customer regulatory submissions, including detailed manufacturing information and quality documentation.
Partnership Approach
Long-Term Collaboration for Pharmaceutical Excellence
Long-Term Cooperation
We view our customers as
long-term partners,
committed to supporting your
success through consistent
quality, reliable supply, and
responsive technical service.
Audit Support
Our facilities and systems are
prepared for customer and
regulatory audits. We
welcome site visits and
provide full transparency in
our operations.
Regulatory Collaboration
Dedicated regulatory affairs
specialists work closely with
your team to ensure smooth
submissions and ongoing
compliance support.
Development Support
Technical expertise available
for formulation development
projects, including analytical
method transfer and
customised specifications.
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