In the pharmaceutical excipient industry, a complete and standardized certification system is the core competitiveness of manufacturers. Although most domestic HPMC producers only have basic qualifications, Meska Joinway stands out as one of the few Chinese manufacturers that possess a complete domestic and international Pharma Grade HPMC certification system. From domestic drug registration applications to global authoritative certifications, religious compliance requirements, and carbon footprint verification, our comprehensive qualification system demonstrates strict quality control, standardized production processes, and long-term stable supply capabilities. We always provide cellulose ether excipients to global pharmaceutical customers with high purity, low impurity content, and highly consistent performance.

1. Domestic Certifications: Strict Compliance for the Chinese Market

1.1 CDE Registration

Our pharmaceutical-grade HPMC has been officially registered by CDE and has obtained a unique filing number. In accordance with the NMPA raw material management standards, we have completed process validation, impurity assessment, and systematic technical review. All production data can be traced and fully complies with the registration and production requirements of domestic pharmaceutical enterprises.

1.2 ISO Certification

We have obtained ISO 9001 (quality management), ISO 14001 (environmental management), and ISO 45001 (occupational health and safety management) certifications. The complete ISO system has standardized all production processes, ensuring consistency between batches, viscosity stability, and uniformity of substitution levels.

2.International Authoritative Certifications: Access to Global High-End Pharmaceutical Markets

2.1 Excipact GMP

As one of the most stringent international standards in the field of pharmaceutical excipients, Excipact GMP embodies strict impurity control and standardized production management. Meska Joinway fully complies with the requirements of Excipact and strictly controls endotoxins, residual propylene oxide and harmful impurities. Our products are particularly suitable for eye drops, sustained-release tablets and other high-end pharmaceutical preparations.

2.2 US FDA DMF

Our pharmaceutical HPMC has completed the DMF filing with the US Food and Drug Administration (FDA). All production processes, quality standards, impurity data, and stability records have been officially certified by the FDA. Our products fully comply with the US Pharmacopeia (USP) standards and can pass the on-site audits conducted by the FDA.

2.3 CEP Certificate

Our CEP certification application is currently under review and is expected to be officially approved within this year. During the pre-certification assessment, our HPMC fully complies with the European Pharmacopoeia (EP) standards, demonstrating extremely high transparency, stable gel temperature, and reliable impurity profiles. Once the CEP certificate is obtained, our products will achieve smoother circulation and wider recognition in the European pharmaceutical market.

3. Global Compliance Certifications: Covering Diversified International Demands

3.1 Halal Certification

To meet the market demands in the Middle East, Southeast Asia and the Islamic regions, we have obtained halal certification. All raw materials are sourced from plant-based materials. There is an independent production area and strict isolation management measures are implemented to ensure full compliance with religious regulations.

3.2 Kosher Certification

Our kosher certification from the Jewish authorities attests that our production environment, equipment and raw materials all fully comply with Jewish dietary regulations. This qualification enables us to provide services to high-end pharmaceutical clients in Europe and North America.

3.3 Carbon Footprint Certification (ISO-14067)

To align with the global trend of carbon neutrality, Meska Joinway has obtained carbon footprint certification. By optimizing energy consumption, water usage, and production processes, we produce low-carbon and environmentally friendly accessories that comply with the green procurement standards of international pharmaceutical groups.

As one of the few manufacturers in China with complete qualification certifications, we possess a comprehensive system covering industry-leading qualifications such as CDE registration, GMP, ISO standards, Excipact GMP, FDA DMF, halal certification, kosher certification, and carbon footprint certification. We are actively applying for the CEP certificate and expect to obtain it within this year.

We never view these qualifications as mere paperwork. They are concrete evidence of our solid technical capabilities, strict internal management, and reliable delivery capacity. Adhering to the principles of “quality first” and “compliance-oriented”, we continuously optimize production technologies and enhance product performance. We are committed to providing safe, stable and high-quality pharmaceutical-grade HPMC, and strive to offer more trustworthy Chinese-made auxiliary material solutions for the global pharmaceutical market.