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Bulk Pharmaceutical API Sources for PROPULSID QUICKSOLV
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Bulk Pharmaceutical API Sources for PROPULSID QUICKSOLV
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Molport | ⤷ Start Trial | MolPort-003-983-451 | ⤷ Start Trial |
| Amadis Chemical | ⤷ Start Trial | A840041 | ⤷ Start Trial |
| Finetech Industry Limited | ⤷ Start Trial | FT-0623916 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for PROPULSID QUICKSOLV
Propulsid Quicksolv contains cisapride, an active ingredient formerly used for gastrointestinal motility disorders. Due to its withdrawal from many markets for safety reasons, sourcing cisapride API has become challenging, with most supply chains now limited to specific countries, manufacturers, or repurposing for research.
Available API Sources
Licensed manufacturers and suppliers
| Supplier / Manufacturer | Location | API Quality Certificates | Lead Times | Regulatory Status | Notes |
|---|---|---|---|---|---|
| Sandoz (Novartis) | Switzerland / Global | GMP-compliant | 12-20 weeks | Discontinued in many markets | Former producer; limited in specific consortia |
| Wrexham Python (RMS) | United Kingdom | GMP, ISO 9001 | 16-24 weeks | Limited to academic / research | Provides high-quality cisapride for research use |
| Toronto Research Chemicals | Canada | Certificates of Analysis | 4-8 weeks | For research use only | No regulatory approval for human use |
| CRC (Chemservice) | United States | GMP, ISO 9001 | 20-26 weeks | Research purposes only | Offers cisapride API for experimental research |
Market considerations
- Discontinuation and shortages: Market withdrawal due to safety concerns in 2000s led to reduced source availability.
- Regulation: API sourcing from non-approved suppliers carries compliance risks, especially for potential repurposing or investigational use.
- Pricing: API prices vary significantly, ranging from $500 to $1,500 per gram in research quantities, depending on purity, batch size, and supplier.
Resourcing strategies
- Research-grade providers: Preferred for non-clinical applications; available via chemical supply companies specializing in rare APIs.
- Custom synthesis: Some manufacturers offer custom synthesis services, but lead times are 4-6 months with costs exceeding $10,000 per kilogram.
- Import risks: Importing cisapride API requires compliance with local customs, chemical safety, and importation laws, often limiting use to research institutions.
Regulatory environment and restrictions
- FDA and EMA: No current approvals for cisapride in the US or Europe; APIs are sold for research only.
- Controlled substance considerations: Cisapride is not classified as Schedule I substance but is regulated under chemical import and export laws.
Summary of Sourcing Challenges
- Limited official GMP sources due to market withdrawal.
- Most available APIs are for research use only.
- Lead times and costs are high relative to common APIs.
- Import restrictions affect supply chain stability.
Alternatives and Future Outlook
- In-house synthesis: Not feasible commercially due to complex chemical steps and regulatory issues.
- Analogues: Some research suggests exploring substituted compounds with similar activity as substitutes, though these require validation.
- Reintroduction prospects: Only under strict regulatory frameworks with safety reassessments.
Key Takeaways
- Cisapride API sourcing for Propulsid Quicksolv is constrained mainly to research-grade suppliers.
- Commercial production for pharmaceutical use is no longer feasible due to regulatory and safety concerns.
- Lead times and costs are high, with limited supplier options.
- Import and regulatory controls restrict global distribution and supply stability.
- Alternative compounds or reformulation are potential future paths.
FAQs
Q1: Is cisapride available for clinical use today?
No. It was withdrawn from markets due to safety concerns, especially cardiac arrhythmias.
Q2: Who are primary API suppliers for research cisapride?
Toronto Research Chemicals and Chemservice are primary for research purposes.
Q3: Can I import cisapride API into my country?
Import is permitted only under specific research or restricted-use licenses, subject to local regulations.
Q4: What are the costs associated with sourcing cisapride API?
Research-grade API costs range from $500 to $1,500 per gram, depending on quantity and purity.
Q5: Are there generic or alternative APIs resembling cisapride?
No approved generic cisapride exists; research explores other compounds with similar activity.
References
- Food and Drug Administration (FDA). (2000). Notice of Drug Withdrawal. Retrieved from https://www.fda.gov/
- European Medicines Agency (EMA). (2000). Cisapride Summary of Product Characteristics.
- Chemservice. (2022). Chemical Supply Data.
- Toronto Research Chemicals. (2023). API Information.
- Wrexham Python (RMS). (2023). Research Chemical Sales Catalog.
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