HiSiaddi is an innovative foreign trade service provider driven by dual engines of technology transformation and foreign trade services. It has established a service system framed as "1+2+3+4=1" and can supply DMSO sourced from multiple well-known original manufacturers. As a foreign trade enterprise with R&D capabilities, HiSiaddi has repeatedly resolved customized DMSO product requirements for clients through technological cooperation with manufacturers and precise market demand insight. Below is a case of HiSiaddi delivering customized DMSO solutions.
For more customized service inquiries, please contact HiSiaddi customer service.
The client is a listed biopharmaceutical company based in Bavaria, Germany, focusing on the R&D and commercial production of innovative anti-tumor drugs and cell therapy products. Its products are filed for clinical trials and marketing authorization across multiple EU countries, with all production lines fully complying with EP European Pharmacopoeia, EMA, GMP and REACH pharmaceutical regulatory standards. It is a high-end end-user with extremely high raw material access thresholds, rather than an ordinary trading intermediary or low-end chemical plant.
The enterprise previously sourced customized DMSO exclusively from BASF. However, surging European energy costs and capacity cuts by the original manufacturer drove a 33% year-on-year price hike, while delivery lead times extended from 4 weeks to 11 weeks, completely destabilizing its supply chain. The enterprise launched a program to establish alternative Asian domestic supply chains. It successively engaged fine chemical manufacturers in Japan and South Korea, as well as 5 bulk DMSO producers in China, yet all trial collaborations were terminated due to substandard indicators, packaging and compliance. Upon recommendation by the European Fine Chemicals Association, the enterprise formally entrusted HiSiaddi, a Chinese foreign trade firm, to act as the general contractor for its ultra-high-purity customized DMSO project, with an annual demand of 108 tons delivered in four separate batches. The client issued an official customized technical agreement with far stricter specifications than standard industrial-grade and conventional pharmaceutical-grade DMSO available on the market:
1. Purity: GC-assayed DMSO main component purity ≥99.997%;
2. Trace impurities: Water content ≤0.012%, single heavy metal element <1ppb, mercaptan/dimethyl sulfide odor impurity <0.3ppm, endotoxin <0.001EU/mL;
3. Custom packaging: Abandon industry-standard 200L iron drums / 25L ordinary plastic pails, adopt customized 20L double-layer light-blocking and moisture-resistant pharmaceutical-grade HDPE sealed pails. Each pail is printed with English product name, CAS number, batch traceability QR code and GHS compliance labels;
4. Documentation & Storage & Transportation: Each batch is accompanied by English COA issued by a GLP-accredited laboratory, GMP compliance documents and complete REACH registration dossiers. Full-process constant temperature & humidity sealed ocean transportation with original full-chain temperature & humidity record documents attached to shipments.
HiSiaddi positions itself as a customized supplier of high-end fine chemical raw materials, abandoning low-end industrial raw material resale business and focusing on customized raw material supply for high-end European and American pharmaceutical and new energy clients. It operates three core functional departments: Raw Material Technology Division, EU Compliance Division and Hazardous Goods Customized Logistics Division. The company has access to over ten domestic production facilities with GMP purification certification, a cooperative local German REACH Only Representative (OR) institution, and a dedicated pharmaceutical-grade hazardous goods temperature-controlled logistics team. Its core strengths cover customized product R&D, full cross-border compliance processing, supporting application technology and customized storage & transportation, qualifying it as the turnkey service provider selected by the client.
Most domestic DMSO manufacturers adopt single-stage rectification processes, yielding grades ranging only from 99.8% to 99.9% for pesticides, coatings and general extraction applications. They fail to meet four stringent criteria: 99.997% ultra-high purity, ppb-level heavy metal control, trace sulfide removal and low endotoxin production. Meeting these standards requires a complete set of processes: four-stage negative pressure precision rectification, chelating resin ion exchange for impurity removal, and sterile ultrafiltration in Class 10,000 clean workshops. Few purification factories in China possess mass production capabilities for such specifications. During independent sample trials with manufacturers, the client repeatedly encountered excessive water content, sulfide odor and elevated endotoxin levels, rendering the material unfit for new drug clinical synthesis.
The client-specified 20L double-layer light-blocking moisture-resistant pail is a non-standard size. The pail body requires pharmaceutical-grade light-shielding oxygen barrier masterbatch and double-layer anti-leak inner plugs, necessitating separate mold development by packaging manufacturers. Most plastic factories refuse to bear mold development costs, and lack EU food-contact packaging safety certifications, making the packaging incompatible with European pharmaceutical raw material entry standards and halting sample filling operations.
Classified as UN1993 Category 3 flammable hazardous goods, DMSO requires hazardous goods packaging certificates, ocean transport identification documents and export inspection certificates for domestic export. Entry into Germany mandates REACH registration, full SVHC 253-substance screening, EU OR filing and EP Pharmacopoeia compliance supporting documents. Domestic manufacturers only hold domestic production qualifications with no EU compliance resources. Previous suppliers’ shipments were detained at Hamburg Customs due to incomplete paperwork, incurring substantial port detention fines.
Dimethyl sulfoxide readily absorbs moisture from ambient air; excess temperature and humidity directly cause water content to exceed standards and render batches unusable. The client imposed mandatory requirements: filling, domestic warehousing and transoceanic shipping must maintain an ambient temperature of 15–26°C and relative humidity ≤42%, with original temperature & humidity data recorded every 2 hours. Standard warehouses and ordinary containers lack constant temperature & humidity control, and most hazardous goods freight forwarders lack dedicated logistics solutions for high-purity pharmaceutical DMSO.
HiSiaddi immediately assembled a special project team consisting of process engineers, compliance specialists, packaging coordinators and temperature-controlled logistics supervisors, executing the project in five phases: "Sample Qualification → Packaging Completion → Compliance Documentation Compilation → Mass Production → Customized Storage & Transportation".
1. Conduct on-site inspections of domestic DMSO purification leading factories holding GMP certification and Class 10,000 sterile filling workshops, verifying rectification production lines, precision filtration equipment and third-party testing laboratory qualifications;
2. Collaborate with factory R&D teams to upgrade processes: add four-stage negative pressure rectification, chelating resin deep heavy metal removal and terminal 0.22μm sterile ultrafiltration to existing production lines. All processes operate under sealed nitrogen protection to isolate moisture and external impurities;
3. Produce small-batch samples across three rounds, with each batch undergoing full testing by a GLP-accredited SGS laboratory. All samples passed full-indicator retesting by the German client’s laboratory, formally validating the production process.
1. Engage plastic manufacturers with EU pharmaceutical packaging certifications, negotiate shared mold costs and complete mass production of customized 20L double-layer light-blocking pails;
2. Design pail labels and traceability QR codes per EU GHS standards, with packaging accompanied by EU food-contact material test reports to meet German import packaging audit criteria.
1. Leverage cooperative local German OR institutions to complete DMSO REACH registration and full SVHC substance screening, filing official ECHA registration dossiers;
2. Apply for domestic UN hazardous goods packaging certificates, ocean transport identification and export inspection certificates; compile 16 full English CLP-compliant SDS documents. Simultaneously issue EP Pharmacopoeia compliance statements and complete factory GMP audit documentation, conducting pre-registration with German Customs in advance to eliminate detention risks at the source.
1. Store finished products after filling in HiSiaddi’s own constant-temperature moisture-proof hazardous goods bonded warehouse with 7×24 real-time warehouse temperature & humidity monitoring;
2. Deploy sealed temperature-controlled hazardous goods containers with moisture-proof buffer protection around pails, fitted with automatic temperature & humidity recorders retaining raw data throughout transit. Ship via dedicated pharmaceutical hazardous goods lines direct from Shanghai to Hamburg Port, Germany.
The first batch of 27 tons of customized DMSO completed production, filling, customs declaration and ocean shipping in sequence. The shipment cleared customs without incident upon arrival and passed full inspection at the client’s facility, with all indicators fully matching the customized technical agreement standards.
1. Short-Term Delivery Results: Zero non-compliant indicators for the first shipment, no port detention fines, and immediate deployment in the client’s anti-tumor drug pilot production. Product quality matched original BASF imported raw materials, reducing overall procurement costs by 28% versus European supply sources;
2. Long-Term Contract Signing: The client awarded HiSiaddi exclusive supply rights for its full annual 108 tons of customized DMSO, signing a 3-year annual framework procurement agreement;
3. Business Expansion: Built on trust established through this collaboration, the client subsequently placed customized sourcing orders for two additional high-purity solvents: sulfolane and electronic-grade NMP, all entrusted to HiSiaddi. HiSiaddi became the client’s sole designated supplier of high-purity pharmaceutical solvents in China.
1. Customization Value: Moving beyond generic spot goods trading logic to deliver full-dimensional non-standard customization of purity, impurities, packaging and storage & transportation, precisely matching exclusive technical requirements for clinical-grade raw materials of high-end pharmaceutical companies and mitigating supply disruption risks from overseas original manufacturers;
2. Technical Value: Collaborate with production facilities to iterate and upgrade processes, breaking domestic grade technical bottlenecks and enabling domestic substitution of imported high-end pharmaceutical raw materials;
3. Compliance Value: One-stop resolution of dual compliance requirements covering "China export supervision + EU REACH/EP Pharmacopoeia", addressing core client concerns over customs clearance and regulatory risks;
4. Foreign Trade Competitiveness: Avoid low-price competition; establish irreplaceable long-term cooperation barriers with high-end overseas clients through integrated capabilities including customized R&D, compliance services, technical support and dedicated logistics.
For more customized service inquiries, please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
English
