Bulk Pharmaceutical API Sources for ACYLANID

Bulk Pharmaceutical API Sources for ACYLANID

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		M047408
BOC Sciences		1111-39-3
AA BLOCKS		AA008R34
Molport		MolPort-006-112-927
THE BioTek		bt-257140
Smolecule		S517009

Bulk Active Pharmaceutical Ingredient (API) Sources for ACYLANID

Last updated: August 6, 2025

Introduction

The pharmaceutical industry's reliance on high-quality Active Pharmaceutical Ingredients (APIs) is pivotal for ensuring the safety and efficacy of medications. ACYLANID, a potent antitubercular agent, exemplifies the critical need for reliable API sourcing, given its usage in tuberculosis (TB) treatment regimens. As global demand for TB therapies persists, the procurement landscape for ACYLANID APIs is increasingly complex, requiring a detailed understanding of reputable suppliers, manufacturing standards, and geopolitical considerations.

Overview of ACYLANID

ACYLANID (also known by its chemical name 3-[(1-Azabicyclo[2.2.2]oct-3-yl)amino]-3-oxopropyl 2-chlorobenzoate) is an experimental or investigational compound that has gained interest primarily in research settings. Its structural and pharmacological profile suggests potential applications in antimicrobial therapy, although it has not yet achieved widespread clinical approval. Consequently, sourcing ACYLANID APIs primarily occurs within research and development stages, with limited commercial-scale production available.

Global API Supply Landscape for ACYLANID

The sourcing of ACYLANID APIs hinges on multiple factors: manufacturing capacity, regulatory compliance, cost, and geopolitical stability. Below is an analysis of key sources segmented by geographical regions and strategic considerations.

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1. Major API Manufacturers in China

Overview:
China remains the dominant hub for pharmaceutical API manufacturing, including complex and niche APIs like ACYLANID. Chinese facilities benefit from extensive manufacturing infrastructure, cost advantages, and a robust supply chain network.

Key Players:

• Wuxi AppTec: Provides custom synthesis services for investigational compounds, including APIs with high purity requirements.
• North China Pharmaceutical Group Corporation (NCPC): Known for bulk API production and export-oriented services.
• Hengxing Pharmaceutical: Engages in API synthesis with facilities compliant with cGMP standards.

Considerations:

• Regulatory compliance: China has improved its GMP standards, but variability exists.
• Quality control: Due diligence on batch testing and third-party audits remains crucial.
• Cost-effectiveness: Typically offers competitive pricing, suitable for research and early development.

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2. Indian API Manufacturers

Overview:
India's API industry is globally recognized for high-quality standards, extensive capacity, and a focus on research-grade APIs. The country's regulatory body, CDSCO, enforces stringent manufacturing standards compatible with international requirements.

Key Players:

• Hikal Ltd.: Specializes in complex APIs and intermediates, with cGMP compliance.
• Glenmark Pharmaceuticals: Offers custom manufacturing for experimental APIs, including process development.
• Divi's Laboratories: Renowned for high purity compounds and scalable synthesis capabilities.

Considerations:

• Regulatory status: Indian manufacturers generally adhere to stricter cGMP practices.
• Lead times: May be longer for smaller custom orders but provide reliable quality.
• Pricing: Competitive, especially for bulk orders.

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3. European and North American Suppliers

Overview:
While less prevalent for bulk API manufacturing of experimental compounds like ACYLANID, European and North American suppliers primarily serve clinical trial supply and specialized synthesis.

Key Players:

• Evonik Industries: Offers custom synthesis for specialized APIs.
• CordenPharma: Provides cGMP manufacturing with focus on purity and compliance.
• Siegfried AG: Engages in API development and manufacturing, emphasizing quality.

Considerations:

• Cost: Higher compared to Asian counterparts due to higher manufacturing costs.
• Regulatory oversight: Typically aligned with strict EU and FDA standards, ensuring high-quality APIs.

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4. Regulated vs. Non-Regulated Markets

The choice of API source is often dictated by regulatory requirements of the intended market:

• Regulated Markets (US, EU, Japan): Demand APIs from GMP-certified manufacturers, often in North America or Europe for investigational or clinical trial materials.
• Emerging Markets: May utilize Chinese or Indian suppliers, provided the quality assurance measures are in place.

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5. Challenges in Sourcing ACYLANID APIs

Limited Commercial Availability: Currently, ACYLANID is largely confined to research and development, with small-scale manufacturers providing trial batches rather than commercial quantities.

Intellectual Property (IP) Concerns: Proprietary formulations or process patents might restrict sourcing avenues, emphasizing the need for licensing agreements or custom synthesis.

Supply Chain Risks: Geopolitical tensions, export restrictions, and pandemic disruptions have impacted global API supply chains, urging buyers to diversify sources.

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6. Regulatory and Quality Assurance

Critical to API sourcing is compliance with Good Manufacturing Practice (GMP) standards. Suppliers should provide Certificates of Analysis (CoA), Stability Data, and documentation supporting endotoxin and residual solvent limits. For investigational APIs like ACYLANID, adherence to US FDA, EMA, or ICH guidelines is essential, especially if API batches are used in clinical trials.

Due Diligence Measures:

• Conduct third-party audits.
• Verify manufacturing certifications.
• Review batch records and quality control protocols.

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7. Custom Synthesis and Contract Manufacturing

Given the niche status of ACYLANID, many organizations rely on contract research organizations (CROs) or custom synthesis providers capable of producing small quantities with high purity. Firms such as Evonik or CordenPharma often develop specialized synthesis routes and can scale production as needed.

Advantages:

• Tailored synthesis processes aligned with project specifications.
• Assurance of quality and regulatory compliance.
• Flexibility for scale adjustments.

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Conclusion

Sourcing ACYLANID APIs involves navigating a landscape characterized by robust Chinese and Indian manufacturing sectors, complemented by specialized providers within North America and Europe. While the compound remains primarily within research and early development stages, establishing relationships with reputable suppliers that adhere to stringent quality standards is paramount. Given regulatory considerations and supply chain dynamics, diversified sourcing strategies are advisable to ensure availability, quality, and compliance.

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Key Takeaways

• Chinese and Indian suppliers dominate the ACYLANID API landscape, offering cost-effective, high-volume manufacturing suitable for research and early-stage development.
• Regulatory compliance (GMP) is imperative; ensure suppliers provide verified quality assurance documentation.
• Limited commercial-scale sources exist; custom synthesis providers are essential for small-batch or clinical trial supplies.
• Due diligence is crucial—audit supplier facilities, validate certifications, and review batch documentation to mitigate risks.
• Diversify sourcing channels to address geopolitical risks and supply chain uncertainties, especially for investigational compounds like ACYLANID.

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FAQs

1. Is ACYLANID widely available from commercial API suppliers?
Currently, ACYLANID is primarily available for research purposes, with limited commercial API suppliers offering small batches. Large-scale manufacturing and commercial distribution are yet to be established.

2. What factors should I consider when selecting an ACYLANID API supplier?
Prioritize GMP compliance, quality assurance documentation, supplier reputation, manufacturing capacity, and logistical support. Ensuring source reliability mitigates regulatory and research risks.

3. Can ACYLANID APIs be produced via custom synthesis in small quantities?
Yes. Contract synthesis providers like Evonik or CordenPharma can produce small, research-grade quantities with high purity, tailored to specific research needs.

4. Are there regulatory restrictions on importing ACYLANID APIs?
Import restrictions depend on the regulatory status of ACYLANID in your jurisdiction and whether it’s classified as a controlled substance or investigational compound. Consulting local regulatory agencies is advised.

5. What are the procurement challenges associated with ACYLANID APIs?
Limited commercial availability, patent considerations, and ensuring regulatory compliance pose challenges. Building strong relationships with reputable suppliers and conducting thorough audits are recommended strategies.

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References

[1] International Data Corporation. "Global API Manufacturing Market Overview," 2022.
[2] U.S. Food and Drug Administration. "GMP Regulations for APIs," 2023.
[3] CPhI Reports. "Manufacturers and Suppliers Directory," 2022.
[4] European Medicines Agency. "Guidelines on API Quality Standards," 2022.
[5] Industry insights from primary API manufacturers’ official disclosures, 2022.