HiSiaddi is an innovative foreign trade service provider driven by dual pillars of technology transformation and foreign trade services. It has established a service system framed as "1+2+3+4=1" and can supply fumaric acid sourced directly from multiple well-known original manufacturers. As a foreign trade enterprise with independent R&D capabilities, HiSiaddi has repeatedly resolved customized product demands for fumaric acid through technological transformation cooperation with manufacturers and precise market demand insight. Below is a case study of HiSiaddi delivering customized fumaric acid solutions.
Contact HiSiaddi customer service if you require further customized service support.
The buyer, ItalBio Srl of Italy, is a leading enterprise specializing in mid-to-high-end pharmaceutical excipients and organic dietary raw materials in Southern Europe. Its products are sold in premium Italian pharmacy chains and serve as OEM bases for Swiss infant supplementary food brands. The company’s core product lines include supporting raw materials for ferrous fumarate API, high-effervescent dietary tablets, and children’s chewable nutrition tablets. All products comply with the European Pharmacopoeia (EP), United States Pharmacopeia (USP), EU EFSA E297 additive standards, LFGB, Kosher certification, and EU organic clean label regulations. The enterprise previously imported pharmaceutical-grade fumaric acid from Spain and Germany all year round. Amid surging European chemical raw material prices and supply shortages caused by plant maintenance, the company launched customized procurement from China in 2025, with an annual customized order volume of 112 tons of high-purity fermented fumaric acid.
General industrial-grade and standard food-grade fumaric acid available on the market were incompatible with the client’s formula system. The client set three non-standard mandatory customized technical indicators, yet major domestic mass producers of fumaric acid (Changmao, Landian, Shouguang Fukang of Shandong) operate mass production lines calibrated for standard specifications, manufacturing large-particle generic products. Factories were reluctant to adjust refining, crystallization, grading and screening processes separately for high-end pharmaceutical formulas due to high technical renovation costs, preferring bulk off-the-shelf sales. After four rounds of sample testing, the client encountered three critical defects: abnormal effervescent tablet disintegration, bitter taste in chewable tablets, and excessive impurities in ferrous fumarate intermediates. Continuous R&D sample losses delayed the launch schedule of new products. After unsuccessful rectification efforts by multiple manufacturers, the client formally entrusted HiSiaddi with full oversight of customized raw material R&D, production line technical transformation, pilot verification, and full-chain compliance support.
1. Purity & Impurity Customization: Only biologically fermented fumaric acid is accepted; petrochemical synthetic raw materials are rejected. Minimum main content ≥99.80%, residual maleic acid ≤0.012%, heavy metals (lead, arsenic, cadmium) ≤0.4ppm, ignition residue ≤0.01%. These thresholds are far stricter than national standard limits for standard food-grade products. Excessive trace impurities directly render intermediates unqualified during ferrous fumarate synthesis.
2. Dual Particle Size Grading Customization ① 25–35 mesh compact regular crystals (for effervescent nutritional tablets): Slow, controlled dissolution to prevent instant violent gas generation that causes tablet cracking; ② 140-mesh homogeneous sterile ultrafine powder (for children’s chewable tablets and pharmaceutical intermediates): Uniform particle size distribution, rapid cold-water dissolution without coarse foreign particles, improving chew texture and eliminating scratchy, astringent throat sensations from coarse grains.
3. Traceability & Packaging Customization: Raw materials sourced exclusively from non-GMO corn saccharification liquid for fermentation, with full-chain raw material traceability filing. Conventional 25kg PE-lined woven bags are replaced with customized high-barrier aluminum-plastic composite vacuum bags for light-shielding and moisture resistance, suitable for high-temperature and high-humidity storage in the Mediterranean region. Outer packaging is printed with Italian-English bilingual markings including E297 code, raw material properties, batch numbers, and allergen declarations, fully complying with EU Regulation No. 1169 labeling requirements.
HiSiaddi assembled a special team consisting of organic acid engineers, pharmaceutical formulation specialists, and compliance officers. It selected two manufacturers with flexible customization and technical renovation capacity: Changmao Biotech and Shouguang Fukang. Independent isolated dedicated production lines were deployed to avoid cross-contamination with generic synthetic-grade fumaric acid. Optimization was implemented across four core links: fermentation control, multi-stage deep refining, graded crystallization & screening, and customized packaging.
1. Collaborated with manufacturers to optimize fermentation strains and temperature control procedures, reducing by-product maleic acid generation at the fermentation source;
2. Added two-stage ion exchange and low-temperature activated carbon deep impurity removal processes on top of conventional primary crystallization, followed by secondary negative-pressure recrystallization to eliminate trace heavy metals and coking impurities. Finished product testing recorded maleic acid content at 0.009%, with all impurities outperforming the client’s customized thresholds.
1. 25–35 mesh crystals for effervescent tablets: Adopted stepped slow cooling crystal growth technology to form compact large-particle crystals with controllable dissolution rates, matching the gas generation rhythm of effervescent formulas;
2. 140-mesh ultrafine powder for chewable tablets: Closed low-temperature airflow pulverization plus fully enclosed graded screening to remove coarse particles, concentrating powder particle size within the target range, improving chew texture and eliminating tablet astringency.
1. HiSiaddi locked in designated non-GMO corn deep-processing bases and established full-batch traceability ledgers covering corn raw materials → saccharification liquid → fermentation → refining → finished products. Each batch raw material code corresponds uniquely to finished goods, with EU-recognized raw material traceability compliance documents issued per batch;
2. Coordinated packaging manufacturers to produce high-barrier aluminum foil vacuum inner bags with bilingual compliance printing, meeting EU import label audit standards.
Italian-English bilingual batch-specific Certificates of Analysis (CoA) were issued in accordance with the European Pharmacopoeia and EU food regulations, supplemented by CNAS third-party test reports, English GHS Safety Data Sheets (SDS), batch-by-batch Kosher certificates, and Free Sales Certificates to satisfy customs clearance at Genoa Port, Italy and local pharmaceutical enterprise drug regulatory filing requirements.
HiSiaddi delivered samples in three batches sequentially: 500g laboratory samples → 50kg pilot samples → 1-ton mass production trial material. The Italian client’s R&D center completed full testing covering intermediate synthesis, tablet compatibility, and accelerated stability. All three customized raw material specifications passed all indicators, completely resolving previous defects including tablet cracking, bitter taste, and excessive intermediate impurities. The client signed an annual framework procurement contract for 112 tons: 61 tons of 25–35 mesh crystals for effervescent dietary tablets, and 51 tons of 140-mesh ultrafine powder for chewable tablets and pharmaceutical intermediates. Goods were shipped monthly in 10 separate batches. The first vessel departed Shanghai for Genoa Port, with customs documents passing single inspection clearance. The client’s two formulation production lines achieved full operation, enabling new products to launch on premium health product retailers across Italy and Switzerland.
In the second year of cooperation, the client expanded OEM high-end nutritional product businesses in Greece and Slovenia, placing an additional customized fumaric acid order of 37 tons. The enterprise entrusted HiSiaddi with full coordination of all its organic acid customized procurement projects.
· Comprehensive procurement costs decreased by 27.8% compared with raw materials imported from Germany and Spain; three new product lines successfully penetrated Southern Europe’s premium dietary and API channels;
· Leveraging internal raw material acceptance standards compiled by HiSiaddi, the R&D cycle for new product raw material customization was shortened by 55%, drastically cutting costs incurred by discarded formulation samples.
· Supported by this high-end European customized order, manufacturers completed technical upgrades for pharmaceutical-grade refined production lines and improved EP Pharmacopoeia-compliant fumaric acid quality control systems. With this successful implementation case, they successively secured designated supply agreements with three pharmaceutical excipient enterprises in Portugal and Austria, successfully entering Southern Europe’s premium pharmaceutical raw material supply chain and escaping low-price homogenized competition in low-end industrial-grade fumaric acid.
· Transcended the traditional trading model reliant on spot product price differences, forming an integrated service capability covering customized process implementation, particle size grading modification, traceability control, and full EU compliance support. Technological barriers enabled deep binding with mid-to-high-end pharmaceutical and dietary clients in Western Europe, building differentiated competitiveness within the fumaric acid niche market.
Most domestic fumaric acid manufacturers focus on mass production of low-cost petrochemical synthetic-grade and standard food-grade products, with crystallization and screening equipment calibrated for generic goods. Production priorities center on capacity expansion and cost reduction, lacking refined grading processes tailored to European and American pharmaceutical-grade standards, as well as expertise in downstream pharmaceutical intermediate and tablet formulation characteristics. Mid-to-high-end pharmaceutical and dietary brands in Europe and America are bound by the EP Pharmacopoeia and EU food additive regulations; minor deviations in trace impurities or particle size of raw materials lead directly to finished product scrapping. As a neutral third-party foreign trade service provider, HiSiaddi connects upstream manufacturers’ technical transformation demands with downstream end-user customization requirements, bridging technological and information gaps between China and overseas markets. It not only enables overseas high-end clients to achieve cost reduction through localized Chinese procurement but also supports domestic high-quality fermented fumaric acid to enter Europe’s premium pharmaceutical ingredient market in bulk.
Contact HiSiaddi customer service for further customized service inquiries.
+86-13120989737 
info@hisiaddi.com 
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