Bulk Pharmaceutical API Sources for alseroxylon

Bulk Pharmaceutical API Sources for alseroxylon

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		62816
ABI Chem		AC1L1XU1
Chembase.cn		259
THE BioTek		bt-258492
Smolecule		S518161
Yick-Vic Chemicals & Pharmaceuticals (HK) Ltd.		CC-0511RC
Yick-Vic Chemicals & Pharmaceuticals (HK) Ltd.		PH-5208FA

Bulk Active Pharmaceutical Ingredient (API) Sources for ALSEROXYLON

Last updated: August 1, 2025

Introduction

Alseroxylon, also known as Alseroxolon or Alxeroxylon, is a synthetic pharmaceutical agent historically used for its vasoconstrictive and cerebrovascular protective effects. It has been primarily employed to treat cerebrovascular disorders, although its clinical use has declined in recent years due to safety concerns and evolving treatment protocols. Given its specific pharmacological profile, sourcing high-quality bulk APIs is crucial for research, legacy pharmaceutical manufacturing, and regulatory considerations. This article explores the current landscape of API sourcing for Alseroxylon, focusing on suppliers, manufacturing practices, quality standards, and regional availability.

Pharmacological Profile of Alseroxylon

Alseroxylon is a synthetic derivative related to vasoconstrictors, acting primarily on adrenergic receptors to modulate cerebral blood flow. Its synthesis involves complex chemical processes, necessitating specialized manufacturing capabilities. The APIs are typically produced under Good Manufacturing Practices (GMP) to ensure safety, purity, and efficacy for pharmaceutical formulation.

Global API Manufacturing Landscape

The API manufacturing ecosystem for Alseroxylon is relatively niche, with limited producers capable of manufacturing to pharmaceutical standards. Historically, several regions have contributed to API production, including Europe, Asia, and North America.

• Europe: Known for stringent regulatory standards, European manufacturers often supply APIs for both research and pharmaceutical use. Companies such as Novartis, Sanofi, and smaller contract manufacturing organizations (CMOs) could potentially produce Alseroxylon API under GMP conditions, although specific data on Alseroxylon production is sparse.

• Asia: China and India dominate the bulk API manufacturing landscape, offering competitive prices and large-scale production capacities. Several Chinese chemical manufacturers are capable of producing APIs similar in synthesis and purity to Alseroxylon, often sold via chemical intermediaries or CMOs.

• North America: U.S. and Canadian firms focus on high-purity APIs, primarily for regulatory-approved pharmaceuticals. Due to the historical decline in Alseroxylon's clinical use, direct sourcing from North American manufacturers is limited.

Current Sourcing Options

1. Contract Manufacturing Organizations (CMOs)

CMOs are the primary avenues for acquiring Alseroxylon APIs. These organizations often produce APIs on a contractual basis for research or legacy drugs, adhering strictly to GMP standards.

• Features:

  • Custom synthesis capabilities.
  • Compliance with international quality standards (e.g., USP, EP, JP, ICH).
  • Flexibility in scale from grams to kilograms.

• Leading CMOs:

  • Bachem: Specializes in custom peptide and small-molecule APIs. Although primarily known for peptides, some CMOs within their network can produce complex small molecules like Alseroxylon.
  • WuXi AppTec: Offers extensive API synthesis services, with the capability to produce niche compounds under GMP.
  • Lonza: Known for large-scale manufacturing, possibly capable of producing Alseroxylon in compliance with regulatory standards.

2. Chemical Suppliers and Distributors

Chemical suppliers often do not manufacture APIs but act as intermediaries providing research-grade or pharmaceutical-grade Alseroxylon.

• Notable Suppliers:
  • Sigma-Aldrich (Merck): Offers a range of pharmaceuticals and intermediates. Specific information on Alseroxylon API availability is limited; often, they supply related chemicals or research compounds.
  • Tocris Bioscience: Primarily supplies research chemicals; may offer Alseroxylon for experimental purposes.
  • Alfa Aesar: Similar to Tocris, with a focus on research chemicals; bulk API sourcing for pharmaceutical use may require custom ordering.

3. Regional API Manufacturers

A handful of manufacturers in Asia regularly produce APIs for export based on OEM (original equipment manufacturer) agreements.

• China: The leading API producer globally, with multiple GMP-certified facilities in regions such as Jiangsu and Zhejiang. Many of these manufacturers can produce customized APIs, including Alseroxylon, upon specific development agreements.
• India: Several API producers in Gujarat, Maharashtra, offer production of synthetic pharmaceuticals, often at competitive prices, with requisite GMP certification.

Regulatory and Quality Considerations

When sourcing Alseroxylon APIs, especially for pharmaceutical applications, adherence to regulatory standards is non-negotiable.

• GMP Certification: Ensures the API is manufactured under quality management systems compliant with international standards.
• Certificate of Analysis (CoA): Buyers should verify purity (>99%), residual solvents, and compliance with pharmacopoeial standards.
• Documentation & Traceability: Critical for regulatory dossiers, batch records, and quality audits.

Challenges in Sourcing Alseroxylon API

• Limited Production Data: As Alseroxylon’s clinical use has diminished, fewer manufacturers actively produce it. Often, APIs are produced on a custom basis for research institutions or legacy pharmaceutical companies.
• Regulatory Barriers: Export restrictions, proprietary formulations, and regional regulation complicate procurement.
• Quality Assurance: Variability in manufacturing standards across regions necessitates strict quality validation.

Future Outlook

The decline in clinical use has reduced the overall demand for Alseroxylon APIs, which impacts availability and price. However, ongoing research into cerebrovascular pharmacology and potential repurposing applications could revive interest, prompting specialized manufacturers to resume or expand production capabilities.

Regionally, China and India remain the key sources for affordable API supply, with European and North American suppliers focusing on high-quality, regulatory-compliant products for niche markets.

Key Sourcing Recommendations

• Engage with GMP-certified CMOs experienced in complex small-molecule synthesis.
• Validate suppliers through documentation, audits, and analytical testing.
• Maintain flexibility to adapt to regional supply chain dynamics.
• Monitor regulatory changes affecting pharmaceutical API trade.

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Key Takeaways

• Limited Manufacturers: The niche nature of Alseroxylon production means only specialized or custom manufacturers can supply the API, primarily in Asia and Europe.
• Regulatory Compliance Essential: Sourcing from GMP-certified suppliers ensures safety, quality, and compliance, especially for pharmaceutical use.
• Asia Dominates Supply: China and India provide the majority of API manufacturing capacity, offering competitive prices but requiring rigorous quality validation.
• Research Use vs. Commercial Supply: Many sources cater to research-grade needs; pharmaceutical-grade APIs may require bespoke agreements.
• Potential for Market Revival: Advances in cerebrovascular research could incentivize manufacturers to resume or expand Alseroxylon API production.

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FAQs

1. Is Alseroxylon still commercially available as a bulk API?
Availability is limited; while once widely used, Alseroxylon's decline in clinical application has led to reduced manufacturing. It is largely available through specialized CMOs for research or legacy pharmaceutical manufacturing.

2. What quality standards should I verify when sourcing Alseroxylon API?
Ensure the API complies with GMP standards, has a Certificate of Analysis confirming purity (>99%), and adheres to pharmacopoeial specifications (USP, EP, JP).

3. Can I source Alseroxylon API directly from Chinese manufacturers?
Yes, many GMP-certified Chinese API manufacturers can produce Alseroxylon upon request, often through intermediaries or trading companies specializing in pharmaceuticals.

4. Are there licensed European suppliers for Alseroxylon API?
Due to its limited current clinical use, European suppliers of Alseroxylon are scarce. Most sources are custom production companies with GMP certification.

5. What future trends could impact Alseroxylon API sourcing?
Emerging cerebrovascular research, potential repurposing, and market revivals may boost demand, leading to renewed manufacturing efforts and expanded sourcing options.

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Sources:
[1] Global API Production & Supply Data, Pharmaceutical Technology Reports, 2022.
[2] European Medicines Agency (EMA) Regulations, 2021.
[3] Chinese API Industry Reports, China Chemical Industry Yearbook, 2022.
[4] Contract Manufacturing Organization Capabilities, WuXi AppTec, 2023.
[5] Regulatory Standards for CGMP Compliance, ICH Guidelines, 2020.