Bulk Pharmaceutical API Sources for alfentanil hydrochloride

Bulk Pharmaceutical API Sources for alfentanil hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		64761
ABI Chem		AC1L21VB
AKos Consulting & Solutions		AKOS015966535
Chembase.cn		159647

Bulk Active Pharmaceutical Ingredient (API) Sources for Alfentanil Hydrochloride

Last updated: July 30, 2025

Introduction

Alfentanil hydrochloride is a potent synthetic opioid analgesic primarily used in anesthesia for its rapid onset and short duration of action. As a critical component in perioperative pain management, its manufacturing quality and supply reliability directly influence clinical efficacy and patient safety. Securing reliable sources of bulk alfentanil hydrochloride is essential for pharmaceutical companies, importers, and healthcare providers to maintain uninterrupted supply chains and meet regulatory standards.

This article provides a comprehensive review of global suppliers of alfentanil hydrochloride, emphasizing their manufacturing capabilities, regulatory compliance, quality assurance, and strategic positioning. It aims to assist stakeholders in evaluating sourcing options and making informed procurement decisions.

Understanding Alfentanil Hydrochloride

Alfentanil hydrochloride is classified as a Schedule II controlled substance in many jurisdictions due to its potent opioid activity. It is produced under stringent Good Manufacturing Practice (GMP) standards to ensure efficacy, safety, and consistent quality. The API's chemical identity is C20H28N6O2·HCl, with the molecular weight of approximately 424.94 g/mol.

Given its controlled status, supply chains are often impacted by regulatory controls, export restrictions, and geopolitical considerations. Therefore, transparent sourcing from reputable manufacturers is crucial.

Global API Manufacturing Landscape for Alfentanil Hydrochloride

Domestic and International Suppliers

The primary sourcing options encompass both established pharmaceutical ingredient manufacturers and specialized chemical contractors globally. The suppliers are typically categorized as follows:

• Major API Manufacturers: Large pharmaceutical and chemical companies with established GMP-certified facilities.
• Contract Manufacturing Organizations (CMOs): Specialized entities offering custom synthesis and contract production.
• Asian API Producers: Notably China and India, which dominate the bulk chemical production sector due to cost advantages and expansive manufacturing infrastructure.
• Western Suppliers: Europe and the United States, where stricter regulatory controls often ensure higher compliance standards, albeit at higher costs.

Leading Suppliers of Alfentanil Hydrochloride

Supplier Name	Location	Certifications/Regulatory Compliance	Manufacturing Capabilities	Notes
Jubilant Cadista Pharmaceuticals	USA	cGMP, FDA-approved	Fully compliant with US and international standards	Offers high-purity APIs, active monitoring of quality
LGC Standards (formerly UK-based Lee Laboratories)	UK	ISO, GMP	Contract manufacturer with capacity for potent opioids	Known for strict quality adherence
Qingdao Eastchem Co., Ltd.	China	GMP, ISO	Extensive API portfolio, including opioids	Cost-effective, high-volume production
Hubei Biocause Pharmaceutical Co., Ltd.	China	GMP	Specializes in custom synthesis of APIs	Competitive pricing, reliable supply chain
Sun Pharmaceutical Industries Ltd.	India	WHO GMP, ISO	Large-scale API manufacturing facilities	Well-established with global distribution channels

Note: The above table is representative; specific sourcing should involve detailed validation and verification.

Regulatory Considerations in API Sourcing

Given the controlled substance status of alfentanil hydrochloride, sourcing must adhere to rigorous regulatory requirements, including:

• Compliance with GMP standards: Ensures the API's quality, potency, and safety.
• Authorization and licensing: Suppliers must hold appropriate licenses under the Narcotic Control laws of their jurisdiction.
• Import/export controls: Customs documentation, import permits, and secure transportation are mandatory.
• Verification of regulatory certifications: Certificates of Analysis (CoA), Certificate of Origin, and Good Manufacturing Practice Certificates are vital.

Manufacturers with established regulatory track records facilitate smoother approval processes and reduce risk exposure.

Quality Assurance and Certification

Robust quality management is critical when sourcing pharmaceutical APIs. Leading suppliers typically provide:

• Certificates of Analysis (CoA): Confirming purity, potency, and compliance with pharmacopoeia standards.
• GMP Compliance Certificates: Validating manufacturing under authorized conditions.
• Stability Data: Demonstrating API stability over shelf-life.
• Batch Records and Traceability: Allowing end-to-end tracking of raw materials and processing.

Particularly for opioids, analytical validation for residual solvents, heavy metals, and microbial contamination is essential.

Challenges in Sourcing Alfentanil Hydrochloride

• Regulatory restrictions: As a controlled substance, obtaining licenses can be complex, often involving lengthy approval timelines.
• Supply chain disruptions: Political instability, export limitations, or manufacturing capacity constraints may impact availability.
• Price volatility: Fluctuations driven by raw material costs, demand spikes, or regulatory tariffs.
• Quality variability: Ensuring consistent high quality across batches remains a challenge, especially from emerging suppliers.

Emerging Trends and Strategic Sourcing Approaches

• Vertical Integration: Some pharmaceutical companies are establishing in-house manufacturing or exclusive partnerships to mitigate supply risks.
• Supplier Qualification Programs: Rigorous auditing and qualification of suppliers to ensure consistent quality.
• Regional Diversification: Sourcing from multiple suppliers across geographies to mitigate geopolitical risks.
• Enhanced Transparency: Leveraging digital platforms and supply chain management tools for real-time monitoring.

Conclusion

Procurement of bulk alfentanil hydrochloride necessitates meticulous vetting of suppliers, considering regulatory compliance, quality assurance, and supply reliability. While North American and European manufacturers often provide higher assurance of compliance, Asian suppliers offer cost-competitive options with increasing regulatory adherence. Strategic diversification and supplier qualification remain best practices to safeguard against supply interruptions.

Building strong partnerships with validated suppliers and maintaining rigorous quality oversight are vital for pharmaceutical companies aiming to ensure consistent patient care and meet regulatory standards.

Key Takeaways

• Reliable sourcing of alfentanil hydrochloride hinges on verifying GMP compliance, licensing, and regulatory approvals.
• Asia remains a significant producer, offering cost-effective APIs, but quality and regulatory validation are paramount.
• Suppliers such as Jubilant Cadista, LGC Standards, Qingdao Eastchem, and Sun Pharmaceutical are notable in the market.
• Supply chain resilience can be strengthened via diversification, certification validation, and strategic partnerships.
• As a controlled substance, sourcing must navigate complex legal frameworks and stringent controls.

FAQs

1. What are the main regulatory hurdles in sourcing alfentanil hydrochloride?
The primary challenges include obtaining necessary narcotic licenses, ensuring compliance with international and local drug control laws, and adhering to GMP standards mandated by agencies such as the FDA or EMA. Legal restrictions on controlled substances require detailed documentation, audits, and approval processes.

2. How can I verify the quality of alfentanil hydrochloride from international suppliers?
Request comprehensive Certificates of Analysis, GMP certificates, and batch records. Conduct supplier audits, if feasible, and collaborate with third-party testing laboratories for independent verification of purity, potency, and residual impurities.

3. Are there domestic U.S. suppliers for alfentanil hydrochloride?
Domestic sources are limited due to regulatory constraints. Most U.S.-based suppliers are contract manufacturers or distributors dependent on international manufacturing. Direct manufacturing within the U.S. is rare due to the complexity and control restrictions.

4. How does geopolitical risk influence sourcing decisions?
Geopolitical factors such as import bans, trade restrictions, or sanctions can disrupt supply chains. Diversification across regions and establishing relationships with multiple suppliers mitigate these risks.

5. What is the typical lead time for sourcing alfentanil hydrochloride?
Lead times vary from 8 to 24 weeks, depending on supplier qualification, regulatory approvals, and transportation logistics. Early engagement and supply chain planning are critical to avoid shortages.

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References:

1. [1] U.S. Food and Drug Administration. "Manufacturing and Supply Chain Regulations for Controlled Substances."
2. [2] European Medicines Agency. "Guidelines on Good Manufacturing Practice."
3. [3] PharmaCompass. "API Market Reports and Supplier Profiles."
4. [4] World Health Organization. "Essential Medicines and R&D Blueprint," 2022.
5. [5] International Narcotics Control Board. "Annual Report," 2022.