FENFLURAMINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102	NDA	UCB, Inc.	43376-322-30	1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC	2020-07-15
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102	NDA	UCB, Inc.	43376-322-36	1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC	2020-07-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

FENFLURAMINE HYDROCHLORIDE is a sympathomimetic amine historically used as an appetite suppressant, primarily marketed within weight loss formulations in the 1970s and 1980s. Despite its market withdrawal in many regions due to safety concerns, notably linked to cardiovascular risks, fenfluramine remains a subject of interest in pharmaceutical sourcing and regulatory discussions. The manufacturing, sourcing, and supplier landscape surrounding fenfluramine hydrochloride is complex due to pharmacovigilance requirements, regulatory history, and the discontinuation of its widespread commercial use.

Overview of Fenfluramine Hydrochloride

Fenfluramine hydrochloride is a chiral compound derived from the phenethylamine class, with the chemical formula C_16H_19ClN_2. It was often combined with phentermine in formulations such as fen-phen for weight management. The compound’s synthesis involves multiple chemical pathways, with key intermediates and rigorous quality controls to meet pharmaceutical standards.

Post-market phase-out across many jurisdictions, sourcing fenfluramine hydrochloride has shifted predominantly toward specialized chemical suppliers, research institutions, and bioindustry players involved in regulatory remaining inventories, forensic research, or legacy medicinal products.

Key Suppliers and Manufacturers

1. Top Chemical and Pharmaceutical Suppliers

Despite discontinued production for human therapeutic use, several companies continue to manufacture fenfluramine hydrochloride for research, forensic, and analytical purposes:

Sigma-Aldrich/Merck KGaA
Sigma-Aldrich remains a prominent supplier of research chemicals, including fenfluramine hydrochloride. Their products are supplied to laboratories, research institutes, and analytical services, adhering to stringent quality and safety specifications.
Toronto Research Chemicals (TRC)
TRC offers fenfluramine hydrochloride as a research chemical, emphasizing high purity standards suitable for scientific studies. Their product listings include detailed quality data, ensuring compliance with research applications.
TCI Chemicals
Tokyo Chemical Industry (TCI) supplies fenfluramine hydrochloride primarily for research and analytical testing, with an emphasis on purity and certified quality control measures.
Alfa Aesar (Thermo Fisher Scientific)
Alfa Aesar supplies a variety of pharmaceutical intermediates and research chemicals, including fenfluramine hydrochloride, targeted toward laboratory and preclinical research.

2. Specialty Chemical Manufacturers for Custom Synthesis

A limited number of chemical manufacturers service custom synthesis requests, catering to pharmaceutical companies and research entities:

BASF and Jubilant Biosys
While not offering fenfluramine hydrochloride directly, these companies provide custom synthesis services for related compounds, possibly including fenfluramine derivatives under confidentiality agreements.
Indo American Chemical Corporation
Specializing in custom synthesis, this firm can potentially produce fenfluramine hydrochloride for research purposes, complying with regulatory standards for laboratory use.

Regulatory and Legal Considerations

Fenfluramine hydrochloride’s legal status varies globally. In the U.S., the FDA revoked approval following the Phentermine-Fenfluramine case, classifying it as withdrawn from the market for prescription use (1997). Other jurisdictions, including Europe and Asia, have stricter controls, limiting import and manufacturing to research and analytical purposes.

Importantly, companies engaging in fenfluramine procurement must ensure compliance with chemical control laws, export regulations, and confirm the chemical’s use strictly for research or analytical purposes. Many suppliers require end-user certification to prevent diversion for pharmaceutical manufacturing.

Market Dynamics and Supply Chain Challenges

The supply chain for fenfluramine hydrochloride is characterized by limited commercial production, primarily for research purposes. The discontinuation from major pharmaceutical manufacturers has led to reliance on a small network of specialized chemical suppliers. Supply chain vulnerabilities include:

Limited production runs
Stringent regulatory controls
Potential for counterfeit or substandard products
Ethical considerations related to its history and safety profile

These factors influence procurement strategies, emphasizing due diligence, supplier validation, and regulatory compliance.

Emerging Sources and Future Outlook

Although direct pharmaceutical supply for therapeutic use is virtually nonexistent, ongoing research into fenfluramine’s pharmacology—especially in the context of its recent resurgence for treating certain forms of epilepsy—may influence future manufacturing considerations. Notably, fenfluramine (brand name Fintepla) has been reapproved by the FDA for Dravet Syndrome and Lennox-Gastaut syndrome, but in a regulated pharmaceutical formulation rather than as a raw chemical.

Thus, future supply prospects of fenfluramine hydrochloride for clinical research, off-label uses, or derivative synthesis hinge on regulatory oversight, patent landscapes, and evolving safety profiles.

Conclusion

Sourcing fenfluramine hydrochloride today is predominantly limited to research-grade suppliers, including Sigma-Aldrich, TRC, and TCI, serving scientific, forensic, and regulatory needs rather than clinical or commercial pharmaceutical production. The compound’s regulatory history, safety concerns, and market discontinuation have restricted supply channels, heightening due diligence requirements for procurement. Stakeholders aiming to access fenfluramine hydrochloride must prioritize compliance, verify supplier credentials, and ensure use aligns strictly with research or analytical purposes.

Key Takeaways

Limited suppliers: Presently, fenfluramine hydrochloride is mainly supplied by research-focused companies like Sigma-Aldrich, TRC, and TCI for laboratory and analytical applications.
Regulatory restrictions: Use primarily restricted to research and forensic purposes due to its withdrawal for therapeutic use.
Supply challenges: Market scarcity, stringent controls, and safety concerns limit commercialization opportunities.
Future potential: Relevant in epilepsy research and repurposing studies; regulatory changes could influence supply dynamics.
Due diligence imperative: Buyers must verify legal compliance, supplier credibility, and intended use to avoid regulatory pitfalls.

5 Unique FAQs

1. Is fenfluramine hydrochloride still available for pharmaceutical manufacturing?
No, fenfluramine hydrochloride is not available for pharmaceutical manufacturing post-market withdrawal. It is primarily accessible for research and analytical purposes through specialized chemical suppliers.

2. Can fenfluramine hydrochloride be legally imported for research?
Legality depends on jurisdiction. In many regions, it can be imported for research under strict regulatory compliance, but clinical or therapeutic use remains prohibited.

3. Who are the primary suppliers of fenfluramine hydrochloride?
Major suppliers include Sigma-Aldrich, Toronto Research Chemicals, TCI Chemicals, and Alfa Aesar, focusing on research-grade chemicals.

4. What are the regulatory considerations for procuring fenfluramine hydrochloride?
Procurement must adhere to local chemical control laws, export regulations, and end-use certifications. Its sale and purchase are often restricted to research institutions.

5. What future developments could influence fenfluramine hydrochloride supply?
Re-evaluation of fenfluramine for epilepsy treatment and potential new research could impact sourcing, but regulatory and safety hurdles remain significant.

References

FDA Drug Safety Communication, 1997. "Fenfluramine and dexfenfluramine: Drug safety communication." U.S. Food and Drug Administration.
European Medicines Agency (EMA), 1998. "Withdrawal Assessment Report: Fenfluramine."
Sigma-Aldrich Product Catalog, 2023. Research Chemicals for Scientific Use.
Toronto Research Chemicals Data Sheet, 2023. Fenfluramine Hydrochloride.
TCI Chemicals Product Listing, 2023. Research-Grade Fenfluramine Hydrochloride.

Suppliers and packagers for generic pharmaceutical drug: FENFLURAMINE HYDROCHLORIDE