Service Platform
Related Services and Solutions
We look forward to working with you and providing you with excellent service.
Capabilities
· Compilation of 300+ drug master files (DMFs)
· Export to 90+ countries
· Experienced API R&D, registration, and production team
· Global regulatory and commercial support
· Integrated services spanning the entire industry chain, from intermediates to APIs and DPs
Strengths
Cutting-Edge Production Technologies
Jiuzhou Pharma has cutting-edge R&D service platforms for chiral catalysis, continuous flow reactions, fluorine chemistry, enzyme catalysis, catalyzed coupling reactions, and peptides.
Extensive Manufacturing Network
Our multi-site manufacturing network consists of over 50 production lines in large specialized workshops, multipurpose workshops, and pilot plants, offering kilogram- to tonne-scale manufacturing capabilities that accommodate different demands.
Our production facilities are fitted with state-of-the-art, cGMP-qualified API production equipment that facilitate a range of reactions, including high-pressure dehydrogenation and cryogenic reactions. We also built production facilities for highly potent compounds, featuring two OEB 5 and six OEB 4 production lines.
Our production bases utilize automated technologies, including distributed control systems (DCS), to enable automated temperature control and inert gas sample transfer modules. We also implemented safety instrumented systems (SIS) for hazardous processes to achieve safe, stable intelligent manufacturing.
Powerful Analytical Services
Analytical method development
Analytical method transfer
Analytical method validation
Elemental impurities testing and product release
Stability studies
Structure determination of compounds
Q(SAR) genotoxicity predictions
Impurity reference substance preparation and impurity isolation
Structural identification of reference substances
Crystal form analysis
Microbial detection method development, testing, and release
Advanced Technologies and Engineering
Standard reactions:
Condensation, esterification, hydrolysis, amination, oxidation, alkylation, halogenation, diazotization, peroxidation, diazo coupling, reduction, hydrogenation, etc.
Specialized reactions:
High pressure reactions: Hydrogenation reactors (100–10,000 L)
Cryogenic reactions: Cryogenic reactors (-80°C, 200–2,000L)
Ultra-high-temperature reactions: Up to 350°C
Grignard reaction
Microchannel continuous flow reactions: 100 kg – 100 tonnes/year
Enzyme catalysis
Cost Control
Source control: Our strong R&D capabilities ensure a competitive cost advantage in process development.
Process management: Sophisticated, lean production management systems
Supply chain assurance: In-house starting materials and intermediates
Robust Supply Chain Management
We have an established supplier quality, social, and environmental management system supported by documents such as the Supplier Management Policy and Supplier Code of Conduct. Our supply chain management, quality management, EHS, and other concerned departments work closely to asses and manage suppliers and drive the continuous improvement of suppliers' internal management practices to reduce exposure to supplier risk. We prioritize the procurement and use of energy-saving, water-saving, and material-saving raw materials and products with minimal adverse environmental impacts. The resilience and continuity of the supply chain are among our top concerns. In 2022, we developed the Business Continuity Plan for Raw Material Supply Disruptions. The document presents a supply chain development plan that ensures a quick response to unexpected raw material supply disruptions to ensure the continuity of key business.
Sustainable Delivery
We integrate the environmental, social, and governance (ESG) strategy into our operations management and fulfill our ESG responsibility by upholding our commitments to our shareholders, customers, consumers, employees, the public and community, government and regulatory agencies, and other stakeholders.
We uphold the values of honesty and integrity, maintain operational compliance and standardization, integrate the principles of operational compliance and business ethics into our operations, constantly improve our responsible marketing and intellectual property management policies, and prevent and address compliance risks to maintain sustainable and healthy development.
We received the EcoVadis Silver Medal for Corporate Social Responsibility, with a sustainability performance outperforming 86% of evaluated companies. Our robust manufacturing capacity distributed across multiple production bases ensures a sustainable supply of products.
Business Collaboration
Innovative Drug CDMO Services
Tel: 86-576-85588039
E-mail: bd.cdmo@jiuzhoupharma.com
