As a new foreign trade service provider driven by both technology commercialization and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply original factory goods of acetyl L-carnitine hydrochloride from multiple well-known brands. As a tech-driven foreign trade service provider, HiSiaddi has repeatedly resolved customized product demands for acetyl L-carnitine hydrochloride through technological cooperation with manufacturers and precise insight into market demands. Below is a case of customized acetyl L-carnitine hydrochloride fully implemented by HiSiaddi for overseas clients.
Please contact HiSiaddi customer service if you need more customized service support.
The purchasing party in this cooperation is SPORTWELL Health Group based in Milan, Italy. With 30 years of deep engagement in high-end professional sports dietary supplements and fat-loss special medical preparations across Southern Europe (Italy, Spain, Greece), its products are stocked in nutrition supply warehouses of Serie A football clubs, high-end organic pharmacy chains in Italy, and weight management specialist supporting product catalogs of EU hospitals. All its products comply with USP (United States Pharmacopeia), EP (European Pharmacopoeia), EU EFSA raw material safety regulations, TSE/BSE animal-free control standards, and HALAL halal certification. The group mainly produces three categories of finished products: sustained-release fat-loss tablets, sports energy oral liquids, and enteric soft capsules, all of which adopt refined pharmaceutical-grade acetyl L-carnitine hydrochloride instead of cheap industrial-grade or ordinary food-grade raw materials. It is a benchmark mid-to-high-end purchaser, distinct from low-end intermediaries purchasing large quantities of low-priced goods for mass-market generic health products.
For over a decade, the group had stably sourced customized-specification acetyl L-carnitine hydrochloride from Swiss pharmaceutical manufacturers with an annual fixed purchase volume of 35 tons. However, due to environmental production restrictions on local EU API manufacturers, a 34% year-on-year hike in raw material prices, a raised minimum order quantity of 7 tons for customized products, and an extended ocean delivery cycle of up to 108 days, the group launched a localization replacement project for Chinese-origin raw materials in 2025. The client independently contacted four major domestic manufacturers (Shandong Luwei, Anhui Huabang, Hebei Tianxu, Jiangsu Pulai Pharmaceutical) for sample customization with four exclusive customized technical indicators. Nevertheless, all four manufacturers mainly produced standardized mass-produced general specifications, with continuous production lines built for mainstream universal grades. They were unwilling to adjust fermentation, refining and crystallization processes for niche customized orders. After 7 rounds of unsuccessful sample trials, the client suffered a total loss of over 79,000 EUR in R&D investment and auxiliary material waste, and the launch plan of its new fat-loss oral liquid was postponed by two months. After fruitless negotiations with original manufacturers on process optimization, the client fully entrusted HiSiaddi to coordinate the whole-chain customization work covering raw material traceability, factory screening, technical renovation of production processes, lab and pilot trials, and mass production.
Four mandatory differentiated customized indicators required by the client (far stricter than domestic general standard products):
1. Physicochemical content: HPLC-determined dry basis content of acetyl L-carnitine hydrochloride ≥99.2%, single unknown impurity ≤0.05%, total impurities ≤0.15%, superior to general EP Pharmacopoeia standards;
2. Powder physical indicators: 100-mesh full sieve passing, angle of repose 29°±1°, moisture absorption weight gain <1.0% after 72 hours under 65% humidity environment, compatible with automated high-speed tableting and low-temperature water-soluble formulations;
3. Optical rotation and residue control: Specific rotation -27.5°~-29.0°, single residual organic solvents (methanol, ethanol) <200 ppm, no risk of excessive chloride;
4. Restricted production process: Produced via microbial enzymatic conversion process, chemical synthesis routes are prohibited to meet EU clean label raw material labeling requirements.
HiSiaddi conducted on-site visits to the four manufacturers and sorted out the root causes of failed customization combined with test data of unqualified samples submitted by the client, which are also key reasons why major domestic API manufacturers are generally reluctant to undertake sophisticated customized orders:
The acetylcarnitine production lines of the four major domestic manufacturers are all continuous large-scale crystallization assembly lines with fixed long-term process parameters, cooling rates and solvent ratios. Adjusting crystallization processes to control particle size and angle of repose requires full-line shutdown and tank cleaning, resulting in high one-time shutdown losses of raw materials and labor costs. Prioritizing mass-produced general orders for profitability, manufacturers refuse to separately modify crystallization sections for individual clients.
General mass-produced products can be delivered with internal control of total impurities ≤0.3%, while the client’s customized standard requires total impurities ≤0.15%. A third-stage precision chromatographic refining process must be added on the basis of the original two-stage resin purification. Most manufacturers have no idle chromatographic equipment, and adding new processes will significantly increase production costs, leading to original manufacturer quotations far exceeding the client’s procurement budget.
The fixed cooling rate of general mass production crystallization produces powder with mixed coarse and fine particles and high hygroscopicity, with the angle of repose generally ranging from 36° to 41%. This fails to meet the mandatory requirements of non-caking during automated tableting and complete dissolution at low temperature for oral liquids. Manufacturers can only perform simple crushing and sieving post-production, without optimizing powder physical properties from the crystallization source.
Shandong Luwei and Anhui Huabang use chemical synthesis routes for some mass-produced batches; Hebei Tianxu mainly produces feed-grade raw materials in large packages, and Jiangsu Pulai Pharmaceutical faces tight scheduling of pilot workshops. None of the four manufacturers can simultaneously satisfy the triple customization requirements of biological enzymatic process, ultra-low impurities and powder modification.
HiSiaddi set up a special project team consisting of API process engineers, on-site technical renovation specialists, EU compliance document specialists and procurement cost accounting specialists, and implemented the whole-service workflow of selecting enzymatic production factories → flexible partial technical renovation → iterative multi-batch lab trials → pilot verification → mass customized production scheduling:
Among the four manufacturers, Jiangsu Pulai Pharmaceutical was selected as the customized production entity. The enterprise owns an independent pharmaceutical-grade flexible pilot workshop with full biological enzymatic conversion preparation processes and idle precision chromatographic purification equipment, meeting the technical renovation conditions for pharmaceutical API customization. HiSiaddi negotiated with the factory to utilize the pilot workshop during gaps between mass production orders to share technical renovation costs, lowering the client’s minimum customized batch quantity from the original factory’s 5 tons to 2.8 tons, matching the client’s demand for small-batch trial production in separate lots.
1. Upgrading refining section: Install precision silica gel chromatographic columns on the basis of original two-stage resin adsorption to stepwise remove trace organic impurities and by-products, strictly controlling total impurities ≤0.13% and single unknown impurity ≤0.04%, meeting the content standard of above 99.2%;
2. Resetting crystallization process parameters: Optimize cooling gradient and stirring speed, adopt segmented slow cooling crystallization to control grain size from the crystallization source, followed by low-temperature air flow crushing and graded sieving equipment to precisely achieve full passing through 100-mesh sieve with stable angle of repose at 28.8°;
3. Optimizing solvent recovery system: Adopt low-boiling environmentally friendly solvents and optimize solvent removal processes, with measured residual methanol and ethanol ≤120 ppm, far below the client’s upper limit of 200 ppm;
4. Locking full-process biological enzymatic conversion route: Retain complete records of strain cultivation and enzymatic conversion production throughout the process, eliminating mixing of chemically synthesized raw materials, and issue EU-recognized process statements to meet clean label regulations.
4 batches of laboratory small samples and 3 batches of 80kg pilot trial production were carried out successively. Before delivery of each batch of products, SGS conducted full-item testing in accordance with dual EP and USP standards, and samples were simultaneously sent to the client’s R&D laboratory in Italy for formulation pilot testing. The drying temperature and vacuum degree were fine-tuned according to powder hygroscopicity, and all indicators finally reached the standard, with the client issuing a formal acceptance confirmation letter for qualified samples.
The annual 35-ton procurement order was split: the first trial production batch of 4.5 tons, and the remaining 30.5 tons split into 9 batches scheduled monthly in staggered shifts. Flexible capacity of the pilot workshop was utilized to flexibly adjust production, avoiding process fluctuation risks of one-time mass production. HiSiaddi conducted on-site sampling and retention for each batch, issuing bilingual Chinese-English COA, GMP production qualification and full-process traceability documents.
Customized food-grade moisture-proof fiber drum outer packaging in accordance with Italian drug administration requirements, with bilingual Italian-English labels on drums marking CAS number, EP grade, production process source and storage conditions. Complete supporting documents including TSE/BSE animal-free statement, HALAL certificate, third-party safety assessment report and certificate of origin were provided to meet Italian customs clearance and client incoming inspection standards.
The first batch of 4.5 tons of customized acetyl L-carnitine hydrochloride was shipped from Shanghai Port to Genoa Port, Italy. Full set of test and compliance documents passed dual inspections of Italian customs and client incoming inspection at one time. After the raw materials were put into the client’s three formulation production lines, no layer separation or mold blockage occurred during tableting, and the oral liquid remained clear without precipitation after 90 days of low-temperature storage. The new fat-loss product whose launch had been postponed for two months was successfully launched in high-end Italian pharmacies and Serie A club supply chains. All 35 tons of annual raw materials were delivered smoothly in batches. Compared with the original Swiss imported raw materials, the overall procurement cost decreased by 25.9%, and the ocean delivery cycle was shortened from 108 days to 37 days, greatly improving the client’s global supply chain turnover efficiency.
1. SPORTWELL Group of Italy completely terminated imports from Swiss original manufacturers, with 100% of its annual 35-ton acetyl L-carnitine hydrochloride demand switched to customized domestic raw materials supplied by HiSiaddi. In the following year, it added customized demand for ultra-low impurity ultra-fine powder specially for children’s special medical drops, with an additional annual supporting procurement order of 13.2 tons;
2. Relying on the process accumulation from this customization project, HiSiaddi assisted Jiangsu Pulai Pharmaceutical in perfecting standardized processes for high-end customized enzymatic acetylcarnitine, successfully developing two equivalent mid-to-high-end sports nutrition brands in Spain and Portugal;
3. The client entrusted HiSiaddi as its exclusive customized service provider in China, delegating all customization work for raw materials such as L-carnitine and creatine (amino acid derivatives) to HiSiaddi for overall coordination.
Major domestic manufacturers of acetyl L-carnitine hydrochloride possess mature mass production processes, yet their production lines are designed for general food and ordinary health product specifications. Restricted by production modification costs and production scheduling plans, they are generally unwilling to invest in technical renovations for niche customized orders of overseas mid-to-high-end clients. Relying on self-developed patented formulations, European and American mid-to-high-end special medical and sports nutrition brands impose strict customization thresholds on raw materials in terms of impurities, powder properties and production processes. Independent docking with manufacturers often leads to repeated failed sample trials and delayed projects. Breaking the traditional foreign trade model of only sourcing matching, HiSiaddi acts as a full-chain customized service provider coordinating all links including factory screening, process technical renovation, sample control and compliance support, bridging the adaptation gap between sophisticated customized domestic APIs and high-end European formulations. It not only helps European mid-to-high-end clients smoothly implement localization replacement of raw materials and recover R&D losses, but also assists high-quality domestic API manufacturers to escape low-end homogeneous price competition and access high-value EU pharmaceutical-grade raw material supply chains, achieving long-term win-win results for both supply and demand sides.
Please contact HiSiaddi customer service if you need more customized service support.
+86-13120989737 
info@hisiaddi.com 
English
