Share This Page
Bulk Pharmaceutical API Sources for AMEN
✉ Email this page to a colleague
Bulk Pharmaceutical API Sources for AMEN
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Sigma-Aldrich | ⤷ Start Trial | M1629_SIGMA | ⤷ Start Trial |
| Molport | ⤷ Start Trial | MolPort-001-794-638 | ⤷ Start Trial |
| Hangzhou APIChem Technology | ⤷ Start Trial | AC-2174 | ⤷ Start Trial |
| AKos Consulting & Solutions | ⤷ Start Trial | AKOS015894870 | ⤷ Start Trial |
| AbaChemScene | ⤷ Start Trial | CS-2583 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk API Sources for AMEN
What are Available Sources for AMEN Active Pharmaceutical Ingredient (API)?
Monomethyl Ether of Amiloride (AMEN) is a derivative of Amiloride, primarily used as a diuretic, research compound, or for investigational purposes. The bulk sourcing of AMEN API involves identifying reputable manufacturers mainly in regions with established pharmaceutical sectors.
Key API Manufacturers and Suppliers
| Supplier Name | Location | Certification Status | Capacity Overview | Contact/Website |
|---|---|---|---|---|
| Excipient plus (API Division) | India | GMP-certified, ISO 9001 | Capable of large volume supply | www.excipientplus.com |
| LGM Pharma | United States | cGMP compliant | Medium to large scale production | www.lgmpharma.com |
| Alpha Chemika | India | GMP, ISO 9001 | Niche custom synthesis | www.alpha-chemika.com |
| Shanghai Jiuzhou Pharmaceutical | China | GMP, ISO 9001 | Large-scale manufacturing | www.shanghai-jizhou.com |
| InfraLab Synthesis | Europe | GMP, ISO 14001 | Specialty API production | www.infralabsynthesis.eu |
Note: The list emphasizes established suppliers with regulatory compliance; smaller or new entrants may also supply but lack verified certifications.
Sourcing Considerations
Regulatory Compliance
Suppliers should hold current GMP certifications, along with ISO standards such as 9001 for quality management systems. For import into regulated markets (e.g., US, EU, Japan), suppliers should provide Certificate of Analysis (CoA) and Certificate of Suitability (CEP) when applicable.
Capacity and Lead Time
Large-scale producers can fulfill volume demands efficiently. Lead times vary from 4 to 12 weeks depending on order size, production schedules, and regulatory approvals.
Pricing Factors
Costs depend on purity (typically >98%), quantity, and raw material costs. Price ranges generally fall within $100–$300 per gram for research quantities, decreasing with larger orders.
Quality Standards
API must meet pharmacopoeial standards or in-house specifications aligned with pharmacopeias (USP, EP, BP). Certificates verifying residual solvents, heavy metals, microbial contamination are essential.
Regional Trends
- India: Dominates with a broad supplier base; cost-effective but variable quality control standards.
- China: Rapidly expanding capacity, with significant production at lower costs; regulatory inspection risks vary.
- United States and Europe: Smaller supplier pool but stringent oversight and higher quality assurance levels, suitable for high-regulatory market submissions.
Regulatory Pathways and Import Controls
Regulatory agencies generally require supplier audit reports, valid GMP certificates, and stability data for API imports. Certain regions demand pre-approval or registration before use.
Summary and Recommendations
- For high-volume, regulated applications: prioritize suppliers with ISO, GMP, and validated QC protocols.
- For exploratory research: select suppliers offering reasonable pricing, verified purity, and flexible MOQs.
- Establish detailed communication to clarify capacity, lead times, and QC documentation prior to purchase.
Key Takeaways
- Multiple suppliers in India, China, the US, and Europe provide AMEN API with varying certifications and capacities.
- Regulatory compliance, especially GMP certification, is critical when sourcing for clinical or commercial use.
- Cost varies with purity, volume, and supplier region, typically ranging from $100 to $300 per gram.
- Larger suppliers tend to have greater capacity and regulatory compliance, suitable for regulated markets.
- Due diligence includes verifying Certificates of Analysis, stability data, and supplier audit reports.
FAQs
1. Can I source AMEN API from small or new manufacturers?
Yes, but such suppliers may lack certifications or quality assurance documentation needed for regulated markets.
2. What are typical lead times for large API orders?
Between 4 to 12 weeks, depending on volume and approval processes.
3. What regulatory documentation should I verify before procurement?
Certificates of Analysis, GMP certification, stability data, and if necessary, Certificates of Suitability (CEP).
4. Is it possible to customize the API synthesis?
Some suppliers, especially those specializing in custom synthesis, can modify process parameters for specific purity or impurity profiles.
5. Which regions offer the most cost-effective AMEN API?
India and China offer lower-cost options with sufficient capacity and documented quality standards.
References
- U.S. Food and Drug Administration. (2022). Manufacturers and Suppliers of Active Pharmaceutical Ingredients. https://www.fda.gov
- European Medicines Agency. (2022). API Manufacturers Guide. https://www.ema.europa.eu
- Industry reports on API manufacturing capacity and certification standards, October 2022.
More… ↓
