Bulk Pharmaceutical API Sources for PROPULSID QUICKSOLV

Bulk Pharmaceutical API Sources for PROPULSID QUICKSOLV

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-983-451
Amadis Chemical		A840041
Finetech Industry Limited		FT-0623916
AKos Consulting & Solutions		AKOS024456750
AvaChem Scientific		81098-60-4
AvaChem Scientific		2794
BOC Sciences		81098-60-4

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROPULSID QUICKSOLV

Last updated: August 18, 2025

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Introduction

Propulsid Quicksolv, known generically as cisapride, is a prokinetic agent historically used to treat gastrointestinal motility disorders. Due to safety concerns, notably cardiac arrhythmias, its manufacturing was significantly restricted, and current market availability is limited. Nevertheless, for authorized pharmaceutical compounding, research, or analytical purposes, sourcing high-quality bulk cisapride API remains vital. This article provides a comprehensive overview of potential API sources, emphasizing quality, regulatory compliance, and supply chain considerations pertinent to industry professionals and stakeholders.

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Regulatory Context and Market Overview

Cisapride (Propulsid Quicksolv) was withdrawn or restricted in numerous markets due to adverse cardiovascular events linked to QT interval prolongation (see FDA Drug Safety Communication [1]). Despite this, some suppliers continue to manufacture or stock API under strict compliance standards, often for controlled import, research, or specialized medical use. The legal landscape requires that API sources adhere to Good Manufacturing Practices (GMP), ISO standards, and local regulatory approvals.

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Primary API Suppliers for Cisapride (Propulsid Quicksolv)

1. Major Pharmaceutical-Grade API Manufacturers

a. Sigma-Aldrich / Merck Group

Sigma-Aldrich remains a historically significant vendor for pharmaceutical-grade chemicals, including APIs. Their catalog includes cisapride suitable for research and analytical purposes, though procurement is heavily regulated and restricted for certain applications [2]. Products are characterized by high purity (>99%), batch consistency, and comprehensive documentation, complying with GMP standards.

b. TCI Chemicals

Tokyo Chemical Industry (TCI) supplies a range of pharmaceuticals and intermediates. Their cisapride API is available primarily for research use, with specifications aligned with international standards. Their distribution channels serve global markets, including North America and Europe, with documentation to support regulatory compliance [3].

c. Tocris Bioscience

Tocris provides cisapride for research purposes, primarily in academic and institutional settings. Their API sourcing emphasizes purity and quality, although commercial pharmaceutical manufacturing for human use requires additional licensing. Their products are suitable for preclinical studies under stringent safety protocols [4].

2. Contract Manufacturing and Custom API Production

Several contract manufacturing organizations (CMOs) can synthesize cisapride API upon request, often adhering to client-specific GMP protocols.

a. Patheon (PPD)

Patheon possesses capabilities for custom API synthesis, including cisapride, supplied under strict quality agreements. They can tailor processes to meet specific purity and stability parameters, ensuring compliance with pharmaceutical standards.

b. Dr. Reddy’s Laboratories

This Indian-based CMO has extensive experience manufacturing APIs, including discontinued drugs, under GMP conditions. They can produce cisapride for research and investigational purposes where permitted.

3. Asian API Suppliers & Distributors

a. Beijing Union Pharmaceutical Technology and Shandong Forchun Pharmaceutical

These Chinese API manufacturers produce a range of APIs, including cisapride, primarily for bulk research and export to licensed entities. They often offer competitive pricing and flexible MOQ (minimum order quantity), but regulatory compliance verification is critical before procurement.

b. Spectrum Chemical

Spectrum Chemical supplies research-grade APIs, including cisapride, with a focus on laboratory applications. Their products are well-documented and compliant with safety standards but are not intended for therapeutic human use.

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Secondary Sources and Market Considerations

4. Online Chemical Suppliers & Marketplaces

There exist numerous online chemical intermediates vendors offering cisapride API, often marketed as research chemicals. Such suppliers include:

• Alfa Aesar
• Cayman Chemical
• Toronto Research Chemicals

However, purchasers must verify supplier credibility, GMP compliance, and proper documentation to avoid counterfeit or substandard products.

5. Regulatory Outlook and Restrictions

Given the drug's adverse safety profile, regulatory authorities have restricted the distribution of cisapride. Import permits, import/export licenses, and strict adherence to controlled substance regulations are mandatory in many jurisdictions (e.g., FDA, EMA, CDC). Potential buyers should consult local regulations and confirm supplier compliance frameworks.

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Supply Chain, Quality, and Compliance Factors

• Quality Assurance: Ensure API suppliers provide comprehensive COA (Certificate of Analysis), batch records, and stability data. Prefer suppliers compliant with ISO 9001, GMP, and other relevant standards.
• Regulatory Approval: Verify that the API is authorized for your intended use—research, manufacturing, or compounding—and adhere to local legal restrictions.
• Supply Security: Engage with reputable vendors with established logistics channels, especially considering geopolitical constraints and export restrictions.
• Pricing and MOQ: Be aware of cost implications and minimum order quantities, which vary widely depending on supplier type and destination market.

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Conclusion

The procurement of bulk cisapride API (Propulsid Quicksolv) entails navigating a complex landscape of regulatory limitations, supplier quality, and supply chain logistics. Major research chemical suppliers like Sigma-Aldrich, TCI, and Tocris provide high-purity API primarily for research purposes, with strict compliance considerations. Contract manufacturing organizations offer tailored synthesis under GMP standards for specialized needs. Asian manufacturers and online marketplaces can provide competitive options but require due diligence concerning regulatory adherence and product authenticity.

Business professionals must prioritize compliance with local and international regulations, maintain rigorous quality standards, and establish reliable, verified supply channels. The restrictive safety profile of cisapride underscores the importance of legal clarity and adherence to appropriate usage protocols.

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Key Takeaways

• Regulatory Compliance is Paramount: Ensure API sources comply with GMP, ISO, and local regulatory standards, especially given cisapride’s safety profile.
• Source Reputable Suppliers: Prioritize established, certified vendors such as Sigma-Aldrich, TCI, and Tocris to guarantee product purity and documentation.
• Assess Supply Chain Risks: Consider geopolitical factors, export restrictions, and logistical reliability when selecting API sources.
• Legal and Safety Considerations: Confirm legal authorization for procurement and use within your jurisdiction. Avoid sourcing from unverified vendors to minimize counterfeit risks.
• Tailor Procurement to Purpose: Research-grade APIs are suitable for analytical or preclinical research; pharmaceutical manufacturing requires strict licensing and compliance.

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FAQs

1. Is cisapride API available for commercial manufacturing today?
Due to safety concerns, cisapride manufacturing has been heavily restricted or discontinued in many markets. It remains available primarily for research and investigational use through licensed suppliers.

2. How do I verify the authenticity of cisapride API from online suppliers?
Request comprehensive documentation such as COA, batch records, and verification of GMP certification. Prefer vendors with established reputations and traceability.

3. What are the main regulatory challenges when sourcing cisapride API?
Regulatory authorities restrict cisapride’s distribution owing to safety risks, requiring import permits, licenses, and adherence to controlled substance laws, depending on jurisdiction.

4. Can I source cisapride API from Chinese or Indian manufacturers for pharmaceutical use?
Only if the supplier is GMP-certified and the API complies with local regulatory standards. Otherwise, the API may only be suitable for research purposes.

5. Are there alternatives to cisapride for gastrointestinal prokinetic research?
Yes; other agents such as prucalopride or erythromycin derivatives may be used. Researchers should evaluate safety profiles and regulatory status when selecting alternatives.

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References

[1] FDA Drug Safety Communication. "FDA updates safety information for cisapride." 2011.
[2] Sigma-Aldrich Catalog. "Chemicals and APIs." [Accessed 2023].
[3] TCI Chemicals Product Catalog. "Research chemicals and APIs." [Accessed 2023].
[4] Tocris Bioscience. "Pharmacological tools and APIs." [Accessed 2023].