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
ABI Chem		AC1OCEJB
Chembase.cn		154255
ChemTik		CTK8E8558

Bulk Active Pharmaceutical Ingredient (API) Sources for: Cisapride Monohydrate

Last updated: August 7, 2025

Introduction

Cisapride monohydrate is a prokinetic agent historically utilized for the treatment of gastrointestinal motility disorders. Although its clinical use has been largely discontinued due to safety concerns, notably cardiac arrhythmias, it remains a subject of interest within pharmaceutical manufacturing and research, especially for regulatory and investigational purposes. The procurement of high-quality bulk APIs, such as cisapride monohydrate, is essential for ongoing research, analytical validation, or custom compounding. This article examines the primary sources of cisapride monohydrate, considering global API suppliers, manufacturing standards, regulatory considerations, and the due diligence necessary for sourcing.

Overview of API Sourcing in Pharmaceutical Industry

API sourcing involves selecting suppliers capable of delivering substances meeting strict quality, purity, and regulatory standards. Global API suppliers typically fall into categories such as original manufacturers, authorized distributors, third-party contract manufacturing organizations (CMOs), and rogue suppliers. Ensuring compliance with Good Manufacturing Practices (GMP) and obtaining proper certifications are critical for pharmaceutical companies and research institutions.

Manufacturers of Cisapride Monohydrate

Historically, cisapride was developed and marketed by Pfizer but was withdrawn from many markets due to safety concerns. Despite this, several manufacturers produce cisapride monohydrate for research and specialty applications:

1. Original Investigational and Commercial Manufacturers:

   • Pfizer, the originator, previously supplied APIs to authorized partners but has since ceased production and distribution of cisapride for commercial use.

2. Generic and Contract Manufacturers:

   • Various third-party manufacturers, often based in China and India, produce cisapride monohydrate for research purposes. These manufacturers usually operate under GMP facilities, although the regulatory status varies.

3. Research-Grade API Suppliers:

   • Companies such as Toronto Research Chemicals (TRC), Sigma-Aldrich (Merck), and TCI (Tokyo Chemical Industry) supply research-grade cisapride, including monohydrate forms, suitable for laboratory use.

Key API Suppliers for Cisapride Monohydrate

Supplier	Location	API Quality Standards	Certification	Notable Features
Toronto Research Chemicals (TRC)	Canada	Analytical Grade, Research Grade	QC Certificates	Widely used for research, purity verification, stability data available
Sigma-Aldrich / MilliporeSigma	USA/Germany	Analytical Grade	GMP if specified, Certificates of Analysis (CoA)	Reliable, high purity, standardized packaging
Toronto Research Chemicals (TRC)	Canada	Research Grade	Documented Purity	Broad availability for laboratory applications
Fake or Rogue Suppliers (various)	China/India	Variable	Often lacking proper GMP certification	High risk of substandard, impure products, potential legal issues

Regulatory and Quality Considerations

When sourcing cisapride monohydrate, especially for research or investigational use, it is imperative to prioritize vendors supplying API with clear certificates of analysis, purity certification, and compliance with recognized standards (e.g., USP, EP, BP). For pharmaceutical manufacturing or clinical studies, sourcing from GMP-compliant suppliers is non-negotiable to meet regulatory standards and ensure safety.

Given the discontinuation of cisapride from commercial markets, many suppliers focus on research-grade APIs that often lack regulatory approval for clinical or commercial use. Nonetheless, they are suitable for analytical method development, preclinical research, or chemical synthesis processes.

Challenges in Sourcing Cisapride Monohydrate

• Market Discontinuation: The withdrawal of cisapride from many regions limits commercial access, increasing reliance on research-grade suppliers.
• Regulatory Restrictions: Some suppliers may operate in jurisdictions with lax oversight, risking substandard products.
• Legal and Ethical Constraints: Use and importation of certain APIs may be regulated; adherence to local laws is mandatory.
• Quality Assurance: Verifying product purity and source authenticity is essential, particularly when dealing with lesser-known suppliers.

Due Diligence for API Procurement

• Supplier Verification: Confirm GMP compliance, certifications, and inspection history.
• Analytical Testing: Independently verify purity and stability through HPLC, NMR, or mass spectrometry.
• Supply Chain Transparency: Ensure traceability from manufacturing to end-user.
• Documentation: Obtain comprehensive CoA, MSDS, and 3rd-party testing reports.
• Legal Compliance: Verify import/export regulations, licensing, and licenses for controlled substances.

Emerging Trends and Future Outlook

While the current landscape restricts the commercial availability of cisapride monohydrate, ongoing research and niche pharmaceutical applications may influence future supply chains. The growth of Chinese and Indian API manufacturers, coupled with advancements in chemical synthesis, suggests potential for increased availability of high-purity cisapride APIs, albeit under strict regulatory oversight.

Research institutions and pharmaceutical compounding entities are increasingly turning to reputable international vendors to secure APIs that meet their specific needs, balancing quality, cost, and compliance requirements.

Conclusion

Sourcing cisapride monohydrate APIs necessitates meticulous supplier vetting due to its discontinued status in mainstream pharmaceutical markets. The best options involve reputable research reagent suppliers like Sigma-Aldrich and TRC, which provide high-purity, well-characterized APIs suitable for investigative purposes. Procurement from rogue or unverified suppliers risks compromising quality, safety, and legal compliance.

In an evolving API landscape, due diligence, regulatory awareness, and quality assurance remain paramount. For individuals and organizations aiming to acquire cisapride monohydrate, establishing relationships with trusted suppliers and performing rigorous testing ensures procurement integrity.

---

Key Takeaways

• Reputable suppliers such as Sigma-Aldrich and Toronto Research Chemicals are primary sources for high-quality research-grade cisapride monohydrate.
• Discontinuation from mainstream markets constricts commercial supply; research-grade APIs serve academic and investigational needs.
• Quality assurance, GMP compliance, and verified certifications are critical for safe procurement.
• Due diligence in supplier verification and analytical testing safeguards against substandard products and legal risks.
• Advances in chemical synthesis may enhance future availability, but regulatory oversight is essential.

---

FAQs

1. Is cisapride monohydrate available for commercial manufacturing today?
No, cisapride has been withdrawn from many markets due to safety concerns. It is primarily accessible for research purposes from specialized suppliers, not for commercial or therapeutic manufacturing.

2. What standards should I look for in a cisapride API supplier?
Seek suppliers that provide GMP certification, Certificates of Analysis, High Purity (analytical grade), and compliance with USP, EP, or BP standards, depending on your application.

3. Can I purchase cisapride monohydrate from any chemical supplier online?
While some vendors sell it as a research chemical, caution is necessary. Verify the supplier’s legitimacy, quality standards, and legal compliance before purchase.

4. How can I validate the purity of the cisapride monohydrate I purchase?
Perform independent analytical testing, such as HPLC, NMR, or mass spectrometry, and review the provided CoA to confirm purity and absence of contaminants.

5. Are there legal restrictions on importing cisapride monohydrate?
Yes, as a controlled or discontinued drug in many jurisdictions, importing cisapride may face regulatory hurdles. Always consult local laws and obtain necessary licenses before importation.

---

References

[1] U.S. Food and Drug Administration. (2011). Withdrawal of Cisapride.
[2] Sigma-Aldrich Product Information. (2023). Cisapride, Monohydrate.
[3] Toronto Research Chemicals. (2023). Cisapride Monohydrate Material Data Sheet.