Mannitol 87-78-5 — China Manufacturer | Pharma-Grade Excipient R&D to Production

Product Overview & China Production Capacity

Mannitol (CAS 87-78-5, molecular formula C₆H₁₄O₆, MW 182.17) is a six-carbon sugar alcohol widely employed as a filler, diluent, and sweetening agent in pharmaceutical solid dosage forms. Chinese manufacturers operate large-scale catalytic hydrogenation lines converting glucose and fructose feedstocks into high-purity D-Mannitol, achieving annual output exceeding 80,000 metric tons across multiple production facilities in Shandong and Henan provinces. This massive production base positions China as the world’s leading Mannitol supplier, delivering consistent pharma-grade material at competitive competitive pricing.

As a non-hygroscopic polyol, Mannitol provides exceptional flowability and compressibility in direct-compression tablet formulations. It serves as the preferred excipient for orally disintegrating tablets (ODTs) due to its pleasant cooling mouthfeel and rapid dissolution. Injectable-grade Mannitol is used as an osmotic diuretic in clinical settings. Chinese production facilities maintain dedicated cleanroom granulation and crystallization units that deliver both powder and granular grades meeting USP/NF, EP, and JP pharmacopoeial requirements.

Manufacturing Standards & Quality Assurance

Our partnered Mannitol manufacturing facilities hold ISO 9001:2015, and ISO 22000 certifications. Each production batch undergoes rigorous quality control including HPLC assay verification (purity ≥98.0%), residual sugar analysis, heavy metals testing (Pb <0.5 ppm), microbial limit testing, and endotoxin screening for injectable grades. Facilities maintain FDA Drug Master Files (DMFs) and CEPs issued by the EDQM, enabling streamlined regulatory submissions in the US and EU markets.

Raw material traceability extends from corn-derived glucose sourcing through final packaging. In-process controls monitor hydrogenation pressure, temperature profiles, and crystallization parameters in real time. Stability studies conducted under ICH Q1A guidelines confirm shelf-life specifications. Every shipment is accompanied by a Certificate of Analysis (CoA) and Certificate of Origin, with samples retained for the full product shelf life.

Technical Specifications

Packaging & Export Logistics

Mannitol is packed in 25 kg multiply kraft paper bags with food-grade PE inner liners, palletized and stretch-wrapped for container loading. Bulk orders of 500 kg or more can be supplied in fiber drums or flexible intermediate bulk containers (FIBCs). All packaging materials comply with FDA 21 CFR and EU Regulation (EC) No 1935/2004 for food-contact materials. Standard lead time is 7–10 business days from order confirmation, with FOB, CIF, and DDP Incoterms available from major Chinese ports including Shanghai, Qingdao, and Tianjin.

Temperature-controlled container options are available for shipments to tropical destinations. Documentation packages include commercial invoice, packing list, CoA, MSDS/SDS, and phytosanitary certificates where required. Our logistics team coordinates customs clearance support and can arrange consolidated shipments for multi-product orders to minimize freight costs.

China Supply Advantage

Sourcing Mannitol directly from Chinese manufacturers eliminates intermediary markups typically adding 15–30% to landed costs. China’s integrated supply chain, from corn wet-milling to finished excipient packaging, ensures stable raw material availability and pricing predictability. With over a decade of export experience to pharmaceutical companies across 60+ countries, Chinese Mannitol producers deliver the reliability, regulatory documentation, and technical support that global formulators demand. Volume-based pricing tiers, flexible payment terms, and dedicated English-speaking account managers make China the strategic sourcing choice for Mannitol procurement.