Bulk Pharmaceutical API Sources for fenfluramine hydrochloride

Bulk Pharmaceutical API Sources for fenfluramine hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F8507_SIGMA
NovoSeek		91452
ABI Chem		AC1L3M3S

Last updated: July 30, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: Fenfluramine Hydrochloride

Introduction
Fenfluramine hydrochloride (FDA code: FDA-6792) is a pharmaceutical compound historically used as an appetite suppressant for weight management. Its regulatory designation has shifted following safety concerns, notably its association with valvular heart disease and pulmonary hypertension. Nonetheless, fenfluramine remains a subject of interest within pharmaceutical research and, in some jurisdictions, permitted for certain therapeutic indications. As demand persists for high-quality bulk APIs, identifying reliable sources for fenfluramine hydrochloride is critical for pharmaceutical manufacturers, research institutions, and compounding pharmacies.

This comprehensive review addresses the current landscape of bulk fenfluramine hydrochloride suppliers, focusing on licensed APIs, manufacturing standards, and regional availability, along with regulatory considerations. We analyze key suppliers, quality assurance practices, and strategic sourcing implications within the context of global pharmaceutical supply chains.

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Regulatory Landscape and Market Overview

Fenfluramine hydrochloride's manufacturing and distribution are heavily regulated due to past safety concerns leading to its withdrawal from the commercial market in many countries, including the U.S. and Europe. However, certain formulations, such as those approved for pediatric pediatric epilepsy (e.g., for Dravet syndrome), have renewed approval pathways, albeit under strict regulatory oversight [1].

Manufacturers of fenfluramine hydrochloride must comply with Good Manufacturing Practices (GMP) endorsed by agencies such as the FDA, EMA, or other relevant authorities. Authorized suppliers typically include established pharmaceutical API producers with demonstrated quality systems, robust analytical validation, and traceability.

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Key Sources of Fenfluramine Hydrochloride API

1. Established International API Manufacturers

Several pharmaceutical API producers possess extensive experience in synthesizing and supplying fenfluramine hydrochloride, primarily catering to research, clinical, or authorized therapeutic markets.

• Akorn, Inc.
  Akorn is a U.S.-based pharmaceutical manufacturer with a history of producing complex APIs, including serotonergic compounds. Their GMP-certified facilities produce fenfluramine hydrochloride for clinical research purposes, with strict quality certifications. Their products are typically available to verified buyers under compliance with regulatory standards.

• CordenPharma (Part of the Siegfried Group)
  CordenPharma offers custom synthesis and commercial-scale manufacturing of APIs, including fenfluramine hydrochloride, mainly for research and specialty markets. The firm adheres to rigorous GMP standards, with a focus on regulatory compliance and quality assurance.

• Viatris (formerly Mosaic Life Science)
  With a diversified portfolio, Viatris manufactures fenfluramine hydrochloride as an API for investigational use, adhering to stringent quality controls. Their global footprint ensures supply chain robustness across North America, Europe, and Asia.

• Hikal Ltd.
  An India-based API manufacturer, Hikal produces fenfluramine hydrochloride for global clients under GMP accreditation. They emphasize quality documentation, stability data, and regulatory compliance, making them a reliable sourcing partner for research and clinical applications.

2. Chinese and Indian API Manufacturers

While some Chinese and Indian manufacturers produce fenfluramine hydrochloride, sourcing from these regions requires diligent verification due to variable regulatory oversight.

• SinoChem Group and Zhejiang Huahai Pharmaceutical
  These firms have capacities for serotonergic APIs, including fenfluramine derivatives, with certifications aligned with international standards. Buyers must perform rigorous due diligence on regulatory compliance, batch consistency, and quality assurance documentation.

• Sun Pharmaceutical Industries and Dr. Reddy’s Laboratories
  Both companies are large Indian API manufacturers with the capacity and GMP compliance to produce fenfluramine hydrochloride for research and clinical use. Their integrations into global supply chains facilitate reliable procurement.

3. Specialty and Contract Manufacturing Organizations (CMOs)

Many CMOs offer custom synthesis of fenfluramine hydrochloride on a contract basis, often serving pharmaceutical and biotech clients seeking clinical-grade APIs:

• Thermo Fisher Scientific
  Offers a range of serotonergic compounds, including fenfluramine hydrochloride, for research use, with documentation supporting GMP manufacturing.

• BASF and Evonik Industries
  As chemical manufacturers with custom API synthesis capabilities, these firms may produce fenfluramine hydrochloride for authorized applications, subject to client validation and regulatory approval.

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Quality Assurance and Regulatory Considerations

The critical factors influencing API sourcing decisions for fenfluramine hydrochloride involve compliance with GMP standards, analytical validation, and documentation of origin. Because of past safety issues, many regulators impose restrictions on fenfluramine distribution; thus, obtaining APIs from approved or authorized suppliers minimizes regulatory risk.

Buyers must ensure:

• Certificate of Analysis (CoA): Confirm purity, residual solvents, and chemical stability.
• Regulatory Licenses: Suppliers should hold current manufacturing and export licenses compliant with ICH Q7 guidelines.
• Quality Certifications: Good Manufacturing Practice (GMP), ISO certifications, and adherence to the US Pharmacopeia (USP) or the European Pharmacopoeia standards.

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Challenges in Sourcing Fenfluramine Hydrochloride API

• Regulatory Restrictions: Due to retrospective safety concerns, many countries have imposed restrictions on fenfluramine's use and import. Suppliers may only provide APIs for investigational or authorized medical purposes.
• Limited Commercial Availability: Few suppliers maintain large inventories, and supply often depends on ongoing clinical trials or specialty pharmaceutical applications.
• Quality Verification: Verifying that a supplier conforms to Western regulatory standards is essential to avoid counterfeit or substandard products.

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Regional Considerations and Supply Chain Strategies

• North America and Europe:
  Sourcing from well-regarded GMP-certified manufacturers ensures compliance with stringent regulatory standards, suitable for clinical trials and authorized therapeutic indications.

• Asia-Pacific:
  While more cost-effective, sourcing from Indian or Chinese manufacturers warrants thorough verification of certifications and quality controls to mitigate regulatory risks.

Strategic Procurement Advice:
Engage with authorized suppliers directly or through licensed intermediaries. Prioritize manufacturers with a proven track record in serotonergic APIs and transparent quality documentation. Consider establishing long-term relationships with GMP-certified producers to ensure consistent supply, especially given the potential regulatory entanglements surrounding fenfluramine's legacy.

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Future Outlook and Sourcing Trends

Renewed interest in fenfluramine derivatives for rare neurological conditions, notably Dravet syndrome and Lennox-Gastaut syndrome, has increased demand for licensed, high-quality APIs for clinical development. Regulatory agencies tend to favor suppliers with proven compliance history, favoring established global pharmaceutical manufacturing firms.

Additionally, innovations in synthesis pathways and quality control methodologies promise enhanced supply stability and purity, facilitating broader access for research and limited therapeutic uses.

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Key Takeaways

• Reliable sourcing for fenfluramine hydrochloride API hinges on strict adherence to GMP standards, regulatory compliance, and traceability.
• Major global manufacturers include Akorn, CordenPharma, Viatris, and Hikal, primarily supplying APIs for research and clinical purposes.
• Chinese and Indian suppliers offer competitive prices but require rigorous due diligence due to regulatory variability.
• Regulatory restrictions significantly influence distribution, with supply mainly restricted to investigational, research, or authorized medical indications.
• Strategic sourcing involves establishing relationships with certified producers, verifying documentation, and aligning with regional regulatory frameworks for safe, compliant procurement.

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FAQs

1. Is fenfluramine hydrochloride readily available for commercial sale?
No. Due to safety concerns and regulatory restrictions, fenfluramine hydrochloride is primarily available for research, clinical, or authorized medical uses. Commercial sales are limited and tightly controlled.

2. What should I verify before purchasing fenfluramine hydrochloride API?
Ensure the supplier provides a valid Certificate of Analysis, GMP certification, manufacturing licenses, and compliance with relevant pharmacopoeias to guarantee quality and regulatory adherence.

3. Can I source fenfluramine hydrochloride from Chinese or Indian manufacturers?
Yes, but buyers must perform thorough due diligence to verify regulatory compliance, quality standards, and manufacturing certifications to mitigate risks associated with variable oversight.

4. What are the main safety and regulatory concerns related to fenfluramine hydrochloride?
Past adverse effects have led to restrictions; supplier compliance with GMP, proper documentation, and adherence to regulatory approvals are critical to ensure safety and legality.

5. How does the renewed medical use of fenfluramine affect API sourcing?
It enhances demand for high-quality, approved APIs, encouraging manufacturers to maintain compliant supply chains and increasing availability within regulatory frameworks for approved indications.

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References

[1] U.S. Food and Drug Administration (FDA). “FDA Approves New Use for Fenfluramine to Treat Seizures in Children.” 2020.