Bulk Pharmaceutical API Sources for cisapride monohydrate

Bulk Pharmaceutical API Sources for cisapride monohydrate

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246975
NovoSeek		6917697
NovoSeek		656684
ABI Chem		AC1LCVEJ

CISAPRIDE MONOHYDRATE BULK API SOURCING ANALYSIS

Last updated: February 19, 2026

Executive Summary

This report analyzes the current landscape of bulk active pharmaceutical ingredient (API) sourcing for Cisapride Monohydrate. Key findings indicate a concentrated supply chain with a limited number of established manufacturers, primarily located in India and China. The analysis details manufacturing capacity, quality control measures, regulatory compliance, and pricing trends relevant to securing reliable and cost-effective supply. Patent expirations and generic competition have influenced market dynamics, creating opportunities for contract manufacturing organizations (CMOs) and smaller API producers.

What is the Global Supply Landscape for Cisapride Monohydrate API?

The global supply of Cisapride Monohydrate API is characterized by a limited number of primary manufacturers. These producers are predominantly situated in India and China, regions recognized for their significant API manufacturing capabilities and cost competitiveness. The market is not characterized by a broad, fragmented supply base but rather by a few key players who have established production capacity and quality systems.

Major API Manufacturing Hubs

• India: Holds a substantial share of global Cisapride Monohydrate API production. Indian manufacturers benefit from a well-established pharmaceutical infrastructure, skilled workforce, and a favorable regulatory environment for API exports.
• China: Another significant producer, with manufacturers contributing to the global supply. Chinese API producers have invested heavily in manufacturing technology and scale, offering competitive pricing.

Key API Manufacturers

While specific company names and proprietary production figures are not publicly disclosed in detail, industry analysis identifies a core group of manufacturers that consistently supply the market. These include both large, diversified API producers and specialized CMOs.

• Established Producers: Companies with a long history of API manufacturing, possessing extensive quality control systems and a proven track record with global regulatory agencies.
• Contract Manufacturing Organizations (CMOs): A growing segment of manufacturers that produce Cisapride Monohydrate API on behalf of various pharmaceutical companies. These CMOs often leverage existing infrastructure and expertise to fulfill specific client orders.

What are the Regulatory and Quality Control Requirements for Cisapride Monohydrate API?

Manufacturing Cisapride Monohydrate API for pharmaceutical use necessitates strict adherence to global regulatory standards and robust quality control protocols. This ensures the safety, efficacy, and consistency of the final drug product.

Good Manufacturing Practices (GMP)

All API manufacturers must comply with current Good Manufacturing Practices (cGMP) as defined by major regulatory bodies.

• US FDA cGMP: Current Good Manufacturing Practice regulations enforced by the U.S. Food and Drug Administration.
• EMA GMP: European Medicines Agency guidelines for GMP.
• WHO GMP: World Health Organization guidelines, often adopted by various national regulatory agencies.
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, which provide a framework for quality, safety, and efficacy. Specifically, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) is critical.

Quality Control Measures

Manufacturers implement comprehensive quality control processes throughout the production lifecycle.

• Raw Material Testing: Verification of identity, purity, and quality of all incoming raw materials.
• In-Process Controls: Monitoring critical process parameters at various stages of synthesis and purification.
• Finished Product Testing: Comprehensive analysis of the final API for identity, purity (including impurity profiling), strength, and other relevant specifications.
  • Assay: Typically >98.5% for Cisapride Monohydrate.
  • Impurity Profile: Identification and quantification of process-related impurities and degradation products. Limits are defined by pharmacopoeial standards and ICH guidelines.
  • Water Content: Monohydrate specification requires controlled water content, typically determined by Karl Fischer titration.
  • Residual Solvents: Limits for solvents used in the manufacturing process, adhering to ICH Q3C guidelines.
  • Heavy Metals: Testing for heavy metal contamination.
  • Microbiological Limits: Ensuring the API is free from excessive microbial contamination.
• Stability Studies: Assessing the API's degradation profile under various storage conditions to establish retest dates and shelf life.

Regulatory Filings and Inspections

Manufacturers must support their products with appropriate regulatory documentation and undergo inspections.

• Drug Master Files (DMFs): Submission of DMFs to regulatory agencies (e.g., US FDA, Health Canada) detailing the manufacturing process, facilities, and quality controls.
• CEP/COS: Certificate of Suitability to the Monographs of the European Pharmacopoeia, demonstrating compliance with European Pharmacopoeia standards.
• Regulatory Inspections: Facilities are subject to periodic inspections by regulatory authorities (FDA, EMA, national agencies) to ensure ongoing compliance with GMP standards.

What are the Patent Expirations and Generic Competition Impacts?

The patent landscape for Cisapride has significantly evolved, leading to widespread generic availability and impacting API sourcing dynamics.

Original Patent Expirations

The composition of matter patents for Cisapride have long expired. This opened the door for generic manufacturers to enter the market.

• Original Patent Expiration (Approximate): Early 2000s (exact dates vary by country and specific patents).

Generic Market Penetration

Following patent expiries, numerous generic versions of Cisapride products have been developed and marketed globally. This has led to:

• Increased Demand for Generic API: A surge in the requirement for cost-effective Cisapride Monohydrate API from generic drug manufacturers.
• Price Pressure on API: Intense competition among generic drug makers translates into significant downward pressure on API pricing. Manufacturers must achieve high efficiency and scale to remain competitive.
• Focus on Cost-Effective Manufacturing: API producers are incentivized to optimize their synthesis routes and production processes to reduce manufacturing costs.

Reformulation and Withdrawal of Innovator Products

It is important to note that Cisapride has faced significant regulatory scrutiny due to cardiac safety concerns (QT prolongation). This led to the withdrawal of the innovator product (Propulsid) in many markets and the restriction of its use to investigational settings or specific patient populations under strict protocols. This historical context impacts the overall market size and the type of entities that are still sourcing Cisapride API.

• Innovator Product Withdrawal (e.g., US): 2000.
• Current Market Status: Primarily used in limited investigational contexts or in regions with different regulatory frameworks. Sourcing is now predominantly driven by niche pharmaceutical companies, research institutions, and markets where it may still be prescribed under specific conditions.

What are the Pricing Trends and Factors Influencing Cost?

Pricing for Cisapride Monohydrate API is subject to market dynamics, manufacturing costs, and regulatory compliance overhead. The current market is largely driven by generic demand for investigational or niche applications, with less focus on broad commercial scale.

Key Pricing Determinants

• Manufacturing Scale and Efficiency: Larger production batches and optimized synthetic routes reduce per-kilogram costs.
• Raw Material Costs: Fluctuations in the prices of key chemical precursors directly impact API production costs.
• Regulatory Compliance: The cost associated with maintaining GMP certifications, conducting stability studies, and preparing regulatory documentation is substantial.
• Geographic Location of Manufacturer: Manufacturers in India and China generally offer more competitive pricing due to lower labor and operational costs compared to Western producers.
• Quality and Purity Standards: Higher purity requirements and stringent impurity profiling can increase manufacturing complexity and cost.
• Supply and Demand: While demand for Cisapride API has decreased significantly from its peak due to product withdrawals, any sudden increase in specific research or investigational needs could impact short-term pricing.
• Contractual Agreements: Long-term supply agreements and bulk purchase commitments can result in preferential pricing.

Estimated Price Range

Based on market intelligence and typical pricing for similar generic APIs from Asia, the price for bulk Cisapride Monohydrate API can range significantly.

• Typical Range: $150 - $400 USD per kilogram.
• Factors for Variation: This range reflects differences in supplier quality, batch size, purity specifications, and the specific terms of the purchase agreement. Manufacturers with strong regulatory filings (e.g., DMFs) and a robust compliance history typically command higher prices.

What are the Supply Chain Risks and Mitigation Strategies?

Securing a reliable supply of Cisapride Monohydrate API involves managing potential risks inherent in the global API market.

Identified Supply Chain Risks

• Regulatory Non-Compliance: A manufacturer failing GMP audits or having regulatory actions taken against them can disrupt supply.
• Quality Issues: Batch failures due to impurities, degradation, or deviations from specifications.
• Geopolitical Instability: Events in key manufacturing regions (India, China) can impact production and logistics.
• Raw Material Shortages: Disruptions in the supply of critical starting materials.
• Logistical Challenges: Shipping delays, customs issues, and transportation disruptions.
• Single-Source Dependency: Reliance on a single API supplier increases vulnerability to any disruption.

Mitigation Strategies

• Supplier Qualification and Auditing: Conduct thorough due diligence, including on-site audits of potential API manufacturers to assess their quality systems, regulatory compliance, and manufacturing capabilities.
• Dual Sourcing: Establish relationships with at least two qualified suppliers to ensure continuity of supply in case of disruption.
• Contractual Safeguards: Include robust clauses in supply agreements related to quality, delivery timelines, force majeure events, and intellectual property.
• Inventory Management: Maintain appropriate safety stock levels of API based on lead times and demand forecasts.
• Regulatory Intelligence: Stay informed about regulatory changes and enforcement actions that could affect API suppliers.
• Contingency Planning: Develop backup plans for alternative logistics providers or emergency sourcing if primary channels are compromised.
• Quality Agreements: Establish detailed Quality Agreements with API suppliers that clearly define roles, responsibilities, and quality standards.

Key Takeaways

• Cisapride Monohydrate API sourcing is concentrated among a few manufacturers in India and China.
• Strict adherence to cGMP, comprehensive quality control, and robust regulatory filings (DMFs, CEPs) are paramount.
• The patent landscape has long been expired, resulting in a generic-driven market with significant price pressure on API.
• Current demand for Cisapride API is limited due to product withdrawals and regulatory restrictions, primarily serving niche or investigational uses.
• Pricing is estimated between $150 - $400 USD per kilogram, influenced by scale, quality, and regulatory standing.
• Supply chain risks include regulatory non-compliance and quality issues; mitigation requires dual sourcing, rigorous supplier qualification, and strong contractual agreements.

Frequently Asked Questions

1. What is the current regulatory status of Cisapride in major markets like the US and Europe? Cisapride has been withdrawn from the market or significantly restricted in the US and Europe due to serious cardiac side effects. Its use is largely limited to investigational settings or specific compassionate use programs under strict monitoring.

2. Are there any known alternative suppliers outside of India and China for Cisapride Monohydrate API? While the majority of bulk API production is in India and China, some Western CMOs may have the capability to produce Cisapride Monohydrate. However, their pricing is likely to be considerably higher, and their focus may not be on this specific API due to the limited market.

3. What are the key impurities to monitor in Cisapride Monohydrate API? Key impurities to monitor include process-related impurities from the synthesis pathway and degradation products. Specific limits are defined by pharmacopoeial monographs and ICH guidelines, with a focus on genotoxic impurities and those that may contribute to adverse effects.

4. How frequently are API manufacturers audited for Cisapride Monohydrate production? The frequency of audits depends on the API manufacturer's regulatory history, the volume of API supplied, and the purchasing company's internal policies. Major regulatory bodies (FDA, EMA) conduct periodic inspections, typically every 2-3 years, while pharmaceutical companies may conduct their own supplier audits annually or biennially.

5. Can the price of Cisapride Monohydrate API increase significantly due to sudden spikes in demand from research institutions? While a sudden, large surge in demand from research institutions could temporarily impact spot pricing for smaller quantities, the overall market for Cisapride API is not currently driven by widespread commercial demand. Therefore, significant, sustained price increases are unlikely unless there is a major shift in its therapeutic application or regulatory landscape.

Citations

[1] U.S. Food and Drug Administration. (2000). FDA Public Health Advisory: Propulsid (Cisapride). [2] European Medicines Agency. (n.d.). Guideline on Good Manufacturing Practice (EudraLex Volume 4). [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline Q3A(R2): Impurities in New Drug Substances. [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2017). ICH Harmonised Tripartite Guideline Q3C(R8): Impurities: Guideline for Residual Solvents.