Cisapride CAS 81098-60-4 — China API Manufacturer | ChP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Cisapride is a serotonin 5-HT4 receptor agonist and gastroprokinetic agent that enhances gastrointestinal motility by facilitating acetylcholine release. With CAS number 81098-60-4 and molecular formula C₂₃H₂₉ClFNO₄, cisapride was historically one of the most widely prescribed GI motility drugs worldwide. While its availability has been restricted in some markets due to cardiac safety concerns, cisapride remains registered and actively marketed in numerous countries across Asia, Latin America, the Middle East, and Africa. China maintains approximately 8 NMPA-registered manufacturers of cisapride API with combined annual production capacity of around 100 metric tons. Our facility continues active production of cisapride API for export to regulated markets where the product maintains valid marketing authorization.

Our Manufacturing Process & Facility Standards

Our cisapride synthesis follows a validated multi-step process starting from 4-amino-5-chloro-2-methoxybenzoic acid, proceeding through amide bond formation, piperidine ring construction, and fluorobenzyloxy side chain introduction. The synthesis requires 8-10 individual steps with overall yields optimized to 15-20%. Production is conducted in our production facility with 16,000 square meters of manufacturing space, utilizing glass-lined and stainless steel reactor systems ranging from 1,000 to 5,000 liters. Final processing stages including recrystallization, filtration, vacuum drying, and milling operate within ISO 14644-1 Class 7 cleanroom conditions. In-process quality controls include HPLC purity monitoring at each intermediate stage, reaction completion verification by TLC, stereochemical purity confirmation (cis:trans ratio), and real-time drying endpoint determination by inline NIR spectroscopy. Batch-to-batch consistency data demonstrates assay RSD below 0.8% across 100+ production batches, confirming well-controlled manufacturing operations.

Quality Standards & Multi-Pharmacopeial Compliance

Our cisapride API is manufactured to meet Chinese Pharmacopoeia (ChP 2020), European Pharmacopoeia (EP 11.0), and customer-specified standards based on ICH Q6A guidelines. Typical assay values reach 99.0-100.5% on a dried basis. Key quality parameters include: related substances by gradient HPLC (each specified impurity ≤0.15%, total impurities ≤0.5%), residual solvents per ICH Q3C, loss on drying (≤0.5%), heavy metals (≤20 ppm), sulfated ash (≤0.1%), particle size distribution by laser diffraction (customizable to customer formulation requirements), and polymorphic form identification by XRPD. Microbial limits testing is performed per pharmacopeial requirements. Stability studies following ICH Q1A demonstrate 48-month shelf life under recommended storage conditions. Each shipment receives complete COA documentation with all test results, chromatographic purity profiles, and batch manufacturing date for customer traceability.

Regulatory Documentation & Registration Support

Our cisapride regulatory documentation includes: NMPA drug registration certificate, Chinese DMF, and supporting dossier formatted in CTD Module 3.2.S structure for international submissions. quality certificates from Chinese provincial drug administration authority are current and available. Given the regulatory complexities surrounding cisapride in certain markets, our regulatory affairs team provides specialized support including: confirmation of active marketing authorizations in target export markets, preparation of market-specific technical dossiers, and coordination with local regulatory consultants in destination countries. We supply cisapride API exclusively to customers who can demonstrate valid local registration or marketing authorization for cisapride-containing finished products. Supporting documentation available includes complete impurity characterization, analytical method validation packages, and reference standard samples with certificates.

Packaging, Storage & Global Logistics

Cisapride API is packaged in double-layer polyethylene bags within aluminum drums, providing effective moisture and light protection. Standard packaging sizes include 1 kg, 5 kg, and 25 kg per drum. Storage conditions require controlled room temperature (below 25°C) in a dry environment protected from light, with validated shelf life of 48 months. We coordinate international shipments to markets in Asia, Latin America, the Middle East, and Africa through established freight partnerships. Typical transit times include: 15-25 days by sea to Southeast Asian ports, 25-35 days to Latin American destinations, 20-30 days to Middle Eastern and African ports, and 5-7 days by air freight to most global destinations. Our logistics team prepares all required export documentation including certificates of origin, free sale certificates, and any market-specific import documentation required by the customer.

Competitive Pricing & Supply Reliability

As an established Chinese manufacturer with years of cisapride production experience, we offer highly competitive competitive pricing that provides significant savings compared to alternative sources. Our integrated manufacturing process and optimized synthesis route deliver favorable production economics. MOQ is 5 kg for evaluation orders, with standard commercial orders from 25 kg. We offer quarterly pricing updates, annual supply agreements with volume commitments, and flexible payment terms for established customers. Production capacity supports monthly output of 2-5 metric tons. Raw material inventory is maintained for 4+ months of continuous production. Given the limited global supplier base for cisapride API, we emphasize supply reliability through advance production planning, safety stock maintenance of 1-2 months for key accounts, and transparent communication regarding any capacity or schedule changes.

Product Specifications