HiSiaddi is an innovative foreign trade service provider driven by dual pillars of technology commercialization and cross-border trading. We have established a "1+2+3+4=1" service system and can supply succinic acid sourced directly from well-known original manufacturers. As a foreign trader with in-house R&D capabilities, HiSiaddi has repeatedly resolved customized product demands for succinic acid through technology cooperation with manufacturers and precise market insight. Below is our case of delivering tailored succinic acid solutions.
Contact HiSiaddi customer service for more customized service support.
The buyer is PharmaSynth GmbH based in Heidelberg, Germany, a mid-to-high-end European API R&D and manufacturing enterprise. It specializes in prescription pharmaceutical buffering excipients and high-end sustained-release formulation intermediates, supplying pharmacy chains across Germany and pharmaceutical factories throughout the EU. Its raw materials comply with USP/EP Pharmacopoeia standards, ICH impurity control requirements, EU REACH regulation, FSSC22000 certification and bio-based carbon footprint certification. The company has an annual demand of 165 tons of custom bio-fermented succinic acid. Previously, it sourced bio-based succinic acid from BASF for years, yet it decided to shift customized procurement to Chinese suppliers amid shrinking overseas production capacity and successive raw material price hikes.
The client put forward three non-standard rigid customized specifications that standard domestic succinic acid products fail to meet:
1. Customized raw material origin: Only corn starch bio-fermentation process is acceptable; petrochemically synthesized succinic acid is rejected. Full-chain bio-based traceability and EU OK-BIO bio-carbon certification are required to support Clean Label labeling for pharmaceutical products.
2. Dual particle size grading customization: ① Regular crystals of 30–40 mesh (for sustained-release tablet excipients to achieve slow dissociation and pH control); ② 150-mesh sterile ultrafine powder (for injection buffering raw materials, fully soluble in cold water with zero insoluble residues). Standard commercial products feature mixed particle sizes and cannot be separately fed into production lines.
3. Ultra-high purity impurity specifications: Succinic acid content ≥99.75%, moisture ≤0.12%, heavy metals (Pb, As, Cd) <0.5ppm, residual methanol and acetic acid below ICH Q3C limits, ignition residue ≤0.015% — far stricter than national standard thresholds for regular food-grade and industrial-grade domestic products.
The client independently contacted three domestic succinic acid manufacturers, all of which focused on mass-produced standard-grade goods. Manufacturers were only willing to supply materials based on their existing production line specifications and refused to revamp crystallization, screening and refining sections for niche high-end customization. A small number of manufacturers could produce high-purity products but failed to deliver full bio-based traceability and separate production of dual particle sizes. Six rounds of sample testing in a row failed to pass formulation test standards. Facing an approaching launch deadline for its new drugs, the client entrusted HiSiaddi with full-process customized development and delivery.
HiSiaddi shortlisted leading domestic enterprises specializing in bio-fermented succinic acid (Cathay Biotech, BBCA Group) and eliminated manufacturers focusing on petrochemical synthesis and general industrial-grade products. We split production processes based on the client’s three customized requirements:
1. Upstream raw material locking: Secure non-GMO corn raw material bases, establish complete production ledgers covering corn procurement, starch saccharification, microbial fermentation and refined crystallization. Retain quality inspection documents of raw materials and fermentation production records for each batch, provide third-party bio-based carbon content test reports and apply for EU OK-BIO bio-traceability certificates.
2. Segmented technical transformation of production lines: Coordinate manufacturers to build two independent crystallization and screening production lines. The first line adopts slow temperature-controlled crystallization to generate uniform 30–40 mesh large-particle crystals; the second line implements low-temperature recrystallization + closed airflow crushing to sieve out 150-mesh sterile ultrafine powder, stored in separate silos to avoid particle mixing.
3. Deep impurity removal through refining: Add two-stage activated carbon decolorization and negative-pressure distillation solvent removal processes outside standard crystallization procedures to strictly control trace heavy metals and organic solvents. Each batch undergoes full-item testing in a CNAS-accredited laboratory in accordance with EP Pharmacopoeia, with English-language COA issued.
1. First round samples: 8kg of each particle size sent to the German R&D laboratory for small-scale tablet formulation and injection compatibility tests. Feedback revealed slight turbidity in injections caused by minor moisture absorption of ultrafine powder. HiSiaddi coordinated the manufacturer to add vacuum drying and moisture-proof coating treatment for powder products, and adjust constant temperature & humidity conditions in the crushing workshop.
2. Second round testing: All physical, chemical and formulation performance indicators fully met standards; pH buffering stability and tablet sustained-release rate outperformed the original imported European raw materials.
1. Customized packaging: Pharmaceutical-grade aluminum-plastic composite inner bags + moisture-proof kraft outer bags. Outer packaging printed in German and English with CAS number, E363 code, particle size, bio-based logo, batch number and country of origin, complying with EU pharmaceutical raw material packaging regulations.
2. Customized documentation: Bilingual EP/USP COA, English REACH-compliant SDS, bio-based traceability documents, Certificate of Free Sale, third-party carbon footprint reports and ICH solvent screening reports provided batch by batch to meet filing requirements of German pharmaceutical authorities.
1. First customized order of 72 tons: 41 tons of 30–40 mesh crystals for oral tablets, 31 tons of 150-mesh sterile ultrafine powder for injections, scheduled across 5 staggered production batches.
2. After arrival at Hamburg Port, all customs and pharmaceutical authority inspections passed without delay, and raw materials were fully deployed for mass production of two of the client’s new drugs.
3. After successful delivery of the first order, an annual framework contract for 168 tons was signed, with long-term fixed production schedules for the two customized specifications.
1. Mid-to-high-end German pharmaceutical enterprise: The cost of customized domestically produced bio-based succinic acid decreased by 27.5% compared with European imports, enabling timely launch of new drugs. Drawing on raw material acceptance specifications compiled by HiSiaddi, the enterprise established internal control standards for incoming succinic acid. An additional customized procurement order of 43 tons was placed for its Austrian subsidiary later.
2. Domestic customized manufacturer: The high-end European pharmaceutical customized order drove refinement and upgrading of production lines, forming standardized customized products of dual-particle pharmaceutical-grade succinic acid. The factory subsequently obtained designated supplier qualifications from two pharmaceutical companies in Switzerland and the Netherlands, opening up supply chains for high-end EU pharmaceutical excipients.
3. HiSiaddi Foreign Trade Service Provider: Our integrated customization service covering raw material traceability control, production line technical transformation, sample iteration and full-set export compliance documents helped us break away from basic price-difference trading and build service barriers for high-end customized bio-organic acids. We continue to receive procurement commissions from multiple fine pharmaceutical enterprises across Europe.
Most domestic succinic acid manufacturers focus on mass production of standard food-grade and industrial-grade products, with production line design and quality control systems aligned with national standards. High transformation costs make manufacturers reluctant to proactively carry out customized production. Mid-to-high-end European and American pharmaceutical enterprises are restricted by pharmacopoeia, ICH rules and bio-label regulations, which impose non-standard thresholds on raw material origin, particle size and trace impurities. As an independent foreign trade service provider, HiSiaddi connects upstream raw material control, factory process transformation, downstream formulation trials and cross-border compliance throughout the full chain, accurately fulfilling high-end customized demands and bridging the customization gap between domestic raw material manufacturers and refined European pharmaceutical buyers.
Contact HiSiaddi customer service for more customized service support.
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