Facilities
Kaifeng Darui Pharmaceutical Co., Ltd. operates GMP-certified facilities in the Kaifeng Fine Chemical Park, equipped with advanced technology to ensure precision, compliance, and sustainability in producing veterinary APIs, pharmaceutical intermediates, and food additives.
Core Production Equipment & Systems
1. GMP-Certified Manufacturing Infrastructure
- Synthesis & Refining Workshops
- 700㎡ production area with two independent lines (synthesis + refining/packaging).
- D-grade cleanrooms (ISO 8 equivalent): Air purification systems, color steel partition walls for contamination control.
- 150t/d wastewater treatment: Eco-friendly recycling compliant with China’s green chemical standards.
- RCO (Regenerative Catalytic Oxidation): VOC emissions reduction for sustainable operations.
2. Precision Processing Equipment
- Distillation & Reaction Systems: High-efficiency distillation towers for API purification.
- Drying & Crystallization:
- Bromonitro alcohol crystallization dryers (patented).
- Double-cone vacuum dryers for heat-sensitive compounds.
- Automated Control: Closed-loop dosing systems and corrosion-resistantmother liquor recovery.
Quality Control & Analytical Laboratories
1. Advanced Testing Instruments
- Chromatography:
- Shimadzu HPLC for impurity profiling.
- Shanghai Yichun GC and FTIR.
- Precision Measurement:
- Electronic analytical balances (±0.1mg accuracy).
- UV-Vis spectrophotometers, melting point analyzers.
- Stability Testing: Climate-controlled chambers for ICH-compliant shelf-life studies.
2. Utility & Support Systems
- Purified Water Systems: USP-grade water for production and cleaning.
- HVAC & Air Handling: HEPA-filtered cleanroom air conditioning for temperature/humidity control.
- Warehousing: Climate-monitored storage for raw materials, finished goods, and hazardous substances.
Compliance & Certifications
- Veterinary drug GMP certification: Full compliance with China’s Veterinary Drug Production Quality Management standards.
- 18 API GMP Certificates: Issued by Henan Province’s Department of Agriculture (November 2024).
- Utility Patents: 12+ patented systems (e.g.,Vacuum distillation anti-corrosion device, bromonitro alcohol recovery devices).
Sustainable & Scalable Operations
- Waste Minimization: Closed-loop solvent recovery and RCO for 95%+ VOC elimination.
- Energy Efficiency: Automated controls reduce energy consumption by 20% vs. industry benchmarks.
- Scalability: Modular facility design supports capacity expansion (current output: 6,000+ tons/year).
Why Partner with Darui Pharma?
- End-to-End Capabilities: From R&D-scale synthesis to GMP production.
- Global Standards: Equipment validated for FDA/EMA-compliant exports.
- Technical Support: 20+ engineers for equipment maintenance, process optimization, and troubleshooting.
Contact Us for OEM/ODM projects, equipment specifications, or facility audits.
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