Enzyme Quality Assurance & International Certifications
GMP-, ISO-, Halal-, Kosher-certified Industrial and Specialty Enzymes for Global Industries, Backed by Rigorous Quality Standards
At Catalex Bio, quality isn’t just part of our process—it’s the foundation of everything we do.
As a manufacturer and global exporter of industrial and specialty enzymes, we ensure that every enzyme we produce at our in-house GMP-, ISO-, FSSAI-, and Halal-certified manufacturing facility meets the highest international standards for purity, activity, and consistency.
In addition to our own production, we partner with carefully audited manufacturing facilities certified for GMP, ISO, FSSAI, Halal, and Kosher compliance, enabling us to offer an expanded portfolio of enzyme solutions across food-grade, pharmaceutical-grade, industrial, and feed applications.
Our comprehensive Quality Assurance System covers every critical aspect — from raw material sourcing and controlled production processes to stringent batch testing — ensuring precise compliance with your specifications and full documentation, including certificates of analysis (COA), Material Safety Data Sheet (MSDS), and Technical Data Sheets.
Our Quality Assurance Process
Multi-tier Quality control protocol that covers the entire supply chain
Certified In-House Production & Partner Network
Enzymes manufactured in our GMP-, ISO-, FSSAI-, Halal-certified facility, or selectively sourced from audited, certified partners for consistent quality and compliance
Batch Testing & Verification
In-house and third-party testing for enzyme activity, purity, microbiological safety, heavy metals, and moisture. Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) provided with every shipment.
Export-Ready Compliance & Traceability
Complete traceability from manufacturing to delivery, with country-specific compliance documents and streamlined export paperwork for efficient customs clearance.
Packaging That Protects Your Product
Food-grade, moisture-resistant, tamper-proof packaging designed to maintain enzyme activity and prevent contamination during transit.
Certifications
Our in-house manufacturing facility and certified partners hold the following certifications:
- GMP (Good Manufacturing Practices) – Controlled, consistent manufacturing standards
- ISO 9001 / ISO 22000 – Quality and food safety management systems
- Halal Certification – For Islamic dietary market requirements
- Kosher Certification – For Jewish dietary compliance markets
- HACCP – Hazard Analysis and Critical Control Point for food safety
- FSSAI (India) – Food Safety and Standards Authority compliance
- Organic Compliance – Available on request for select enzyme categories
Documentation With Every Order
Every enzyme shipment is backed by complete documentation for full compliance and traceability
- COA (Certificate of Analysis): Comprehensive test results detailing potency, purity, and key quality parameters
- TDS (Technical Data Sheet): Detailed product specifications, performance data, and recommended usage guidelines
- MSDS (Material Safety Data Sheet): Guidelines for safe handling, storage, and hazard precautions
- Export Documents: Complete paperwork including invoices, packing lists, airway bills or Bills of Lading, Certificates of Origin, and more for smooth international shipping
- Compliance Certificates: Market-specific compliance certificates ensuring your order meets all applicable regulations