As a new type foreign trade service provider driven by both technology transformation and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply neotame sourced from multiple well-known original manufacturers. As a technology R&D-oriented foreign trade service provider, HiSiaddi has repeatedly resolved customers’ customized demands for neotame by leveraging technological transformation cooperation with factories and precise grasp of market demands. The following is a case where HiSiaddi delivered customized neotame solutions for clients.
If you need more customized service support, please contact HiSiaddi customer service.
The purchaser is SwissCare Pharma GmbH based in Zurich, Switzerland, a leading brand of mid-to-high-end functional dietary and oral preparation products in Europe. Its products are sold in premium organic COOP supermarkets across Switzerland, national chain private pharmacies in Switzerland, and high-end lines of German dm drugstores. The company operates three core product lines: sugar-free oral nutrient solutions for children, high-end sugar-control dietary powders, and medicinal orally disintegrating tablet excipients. Its raw materials comply with three sets of standards: EU EFSA food additive regulations, USP United States Pharmacopeia, and Swiss FOAG food access standards. Targeting zero-additive, high-purity pharmaceutical-grade raw materials for end consumers, it qualifies as a standard mid-to-high-end procurement client.
The client had long purchased original neotame raw materials from US brand NutraSweet. In 2025, prolonged delivery cycles and a 22% price hike by the US manufacturer prompted the enterprise to launch a domestic raw material substitution project. It planned to customize two differentiated modified neotame variants in China: pharmaceutical microcrystalline dispersed neotame and acid-resistant modified neotame for low-temperature beverages, with an annual total procurement volume of 7.2 tons.
The client independently contacted three major domestic neotame manufacturers (Huatian Biotechnology, Jinhe Industrial, Luwei Pharmaceutical), yet all three factories only promoted standardized mass-produced neotame complying with national standards and refused to conduct special customized modification per the client’s formula requirements. Standard off-the-shelf neotame failed to resolve the technical pain points of the client’s production lines, leading to three consecutive failed lab trials, stalled formula R&D, and delayed new product launch plans. The client therefore entrusted HiSiaddi Foreign Trade to fully coordinate customized development and deliver exclusive modified neotame products.
1.
Poor powder dispersibility of neotame for medicinal orally disintegrating tablets leading to uneven feeding The client’s fully automated closed feeding production line for children’s orally disintegrating tablets requires neotame powder with D90 particle size controlled within 18–25 μm. Conventional industrial neotame features coarse crystalline particles prone to electrostatic agglomeration. At a tiny addition dosage of only 8 ppm, uneven sweetness distribution (over-sweet local areas) and mottled tablet sweetness occur. When mixed with excipient microcrystalline cellulose, ordinary neotame agglomerates, causing uniform dispersion failure on Switzerland’s automated dry mixing equipment and unqualified finished product quality inspection. Client requirement: Produce carrier-coated microcrystalline modified neotame using pharmaceutical-grade mannitol as coating carrier to achieve free-flowing powder free of electrostatic agglomeration, compliant with Swiss Pharmacopoeia standards for pharmaceutical excipients.
2.
3.
Rapid hydrolysis attenuation in acidic environments for neotame used in high-acid fruit juice nutrient solutions leading to unqualified shelf life The client’s low-temperature NFC fruit juice nutrient solution has a pH value of 2.6–3.1 and requires a 12-month room-temperature shelf life. Standard national standard neotame suffers over 18% sweetness attenuation after 3 months of storage in acidic systems with pH<3.2, resulting in faded sweetness and unbalanced flavor in mid-to-late shelf stages. Customized target for the client: Acid-resistant modified formula with sweetness loss ≤5% under identical storage conditions, compatible with low-temperature aseptic filling processes.
4.
5.
Customized internal control purity indicators exceed national standards, while factories refuse to adjust purification processes The Swiss import raw material internal control standards set by the client mandate neotame main content ≥99.7%, single unknown impurity ≤0.1%, and methanol solvent residue <10 ppm. The qualified threshold for domestic national standard food-grade neotame is merely ≥98.5%. Mass production lines of the three factories are configured for standardized mass production, and revamping purification sections would raise production costs, so all factories declined to adjust process parameters exclusively for small-batch orders.
6.
7.
Lack of customized supporting compliance documents The client requires customized batch-specific USP Pharmacopoeia test reports, Swiss FOAG raw material filing dossiers, non-GMO notarized documents, and DMF active pharmaceutical ingredient filing supporting materials. Standard factories can only provide Chinese COA reports complying with national standards without customized English compliance dossiers, preventing the client from completing pre-import raw material filing in Switzerland.
8.
Leveraging domestic neotame industrial chain resources, HiSiaddi compared R&D capabilities of the three leading enterprises:
· Huatian Biotechnology: Drafter of national neotame standards, owns a provincial sugar substitute R&D laboratory, holds patents for pharmaceutical-grade modified neotame, and is the only domestic enterprise certified for pharmaceutical-grade neotame production.
· Jinhe Industrial: Focuses on standardized mass production with fully booked modification R&D schedules.
· Luwei Pharmaceutical: Specializes in feed-grade standard neotame with weak refined customization capacity.
Huatian Biotechnology was finalized as the customized production partner. HiSiaddi led the establishment of a three-party special project team consisting of the client’s formula R&D department, the factory’s R&D center, and HiSiaddi quality control, locking a 45-day timeline for lab trials and mass production launch.
1. Process adjustment: HiSiaddi collaborated with the factory to optimize the spray coating process, adopting Swiss Pharmacopoeia-grade mannitol as coating carrier. A low-temperature spray coating section was added after neotame crystallization to precisely control powder D90 particle size at 22 μm and eliminate electrostatic adsorption of raw materials.
2. Lab trial verification: Three gradient samples were sent to the client’s laboratory in Switzerland. The client conducted full-process trial production using its proprietary automated dry mixing equipment, achieving sweetness uniformity error <3% across three consecutive batches of tablets and completely resolving agglomeration and local over-sweetness issues.
3. Internal control purification: Optimized chromatographic purification process to strictly control main component content ≥99.72%, single impurity 0.08%, and methanol residue 7.2 ppm, all exceeding the client’s customized internal control standards.
The joint R&D team adopted molecular coating modification with food-grade polydextrose as surface coating to isolate neotame molecules from hydrolysis damage in acidic aqueous environments. Accelerated aging tests (stored at 37℃, pH 2.8 for 90 days) measured only 4.2% sweetness attenuation, meeting the client’s 12-month shelf life indicator. The product adapts to low-temperature aseptic filling processes with no sweetness loss after high-temperature instantaneous sterilization at 135℃ for 4 seconds.
1. HiSiaddi compliance specialists coordinated with factory quality inspection departments to compile customized full-item English COAs aligned with USP Pharmacopoeia and Swiss FOAG regulations, detailing 17 indicators including physicochemical properties, impurities, and solvent residues.
2. Assisted the factory in sorting customized product process traceability dossiers, strain safety statements, and third-party notarized non-GMO documents. Packaged documents supported the client’s completion of pre-import raw material filing in Switzerland, filling the gap of pre-import compliance materials.
First, small-batch trial production of 300 kg each of the two modified neotame variants was shipped to Switzerland. Full-product line mass production verification by the client revealed no process abnormalities. After successful trial production, an annual framework order of 7.2 tons was confirmed, with balanced monthly production split into 6 batches. HiSiaddi simultaneously coordinated customized batch packaging: nitrogen-filled light-proof food-grade aluminum foil packaging compliant with Swiss import labeling regulations, printed with bilingual labels indicating raw material specifications, country of origin, and pharmaceutical excipient filing codes to avoid customs clearance label risks.
1. Delivery achievements: The two exclusive customized neotame variants were successfully delivered, enabling the client to fully replace US imported raw materials. Comprehensive raw material procurement costs dropped by 17.5%. New children’s nutrient solutions and medicinal orally disintegrating tablets were launched on schedule in premium supermarkets and pharmacies across Switzerland and Germany, achieving single-product sales exceeding 1.92 million Swiss Francs within half a year of launch.
2. In-depth cooperation: The mid-to-high-end Swiss client subsequently entrusted HiSiaddi with full responsibility for neotame customized procurement for its subsidiaries in France and Austria. A new organic gluten-free compound modified neotame customization project was launched the following year, raising annual procurement volume to 12.8 tons.
3. Factory benefits: Relying on this customized project, Huatian Biotechnology improved its modified neotame process library and subsequently secured multiple customized orders from high-end European pharmaceutical enterprises, expanding its high-end export product line.
Most domestic neotame manufacturers focus on standardized bulk mass production as their core profit model, with fixed parameters for mass production lines and reluctance to invest in R&D and process modification for small-batch mid-to-high-end orders. Restricted by strict local pharmacopoeia standards and production line processes, overseas high-end pharmaceutical and dietary brands cannot adapt standardized off-the-shelf raw materials to customized formula demands.
Positioned as a neutral foreign trade service provider, HiSiaddi closes the gap between Chinese and foreign supply and demand information and process modification barriers by covering the full value chain: client demand breakdown → factory R&D screening → formula modification & customization → indicator re-testing → compliance document customization → export packaging. Leveraging refined customized production capacity of leading domestic factories, we help overseas mid-to-high-end clients achieve localized substitution of exclusive raw materials manufactured in China, while supporting high-quality domestic sweetener manufacturers to access the high-end European excipient supply chain.
If you need more customized service support, please contact HiSiaddi customer service.