Suppliers and packagers for FINTEPLA

FINTEPLA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for the Pharmaceutical Drug: Fintepla (Fenfluramine)

Last updated: July 27, 2025

Introduction

Fintepla (fenfluramine) is an FDA-approved medication primarily indicated for the treatment of seizures associated with Dravet syndrome in pediatric patients aged 2 years and older. Originally marketed in the 1990s as a weight-loss drug, fenfluramine was withdrawn from the market due to safety concerns, specifically its association with valvular heart disease. However, it has been repurposed and reintroduced in a controlled form under the brand name Fintepla, developed by Zogenix (now part of UCB), to address unmet needs in severe epilepsy management. The drug's supply chain involves specialized manufacturing and distribution channels, primarily managed by its license holder, UCB.

Manufacturers and Supply Chain of Fintepla

1. UCB – The Licensed Manufacturer

UCB, a global biopharmaceutical company, holds the rights to manufacture, distribute, and commercialize Fintepla in multiple markets:

• Manufacturing Role: UCB maintains the manufacturing facilities responsible for producing fenfluramine under stringent Good Manufacturing Practice (GMP) standards.
• Supply Chain Management: UCB oversees the entire supply chain, including procurement of raw materials, production, quality control, packaging, and distribution.
• Global Reach: UCB's extensive distribution network ensures availability across North America, Europe, and other global markets where regulatory approval has been granted or sought.

2. Raw Material Suppliers

Fenfluramine’s manufacturing process requires high-quality raw materials, primarily chemical precursors and intermediates. Key raw material suppliers include:

• Specialized Chemical Manufacturers: These companies supply the active pharmaceutical ingredient (API) precursors conforming to pharmaceutical-grade specifications. Examples include chemical synthesis firms specializing in aromatic compounds or amines, essential for fenfluramine synthesis.
• Quality and Compliance: Raw material suppliers are subject to rigorous quality controls, including ISO certifications and adherence to GMP standards, ensuring the safe and consistent production of APIs.

3. Contract Manufacturers and CMO Partners

Some pharmaceutical companies utilize Contract Manufacturing Organizations (CMOs) to scale up production:

• CMO Engagement: UCB collaborates with CMOs that possess capabilities in sterile filling, tablet/tablet coating, and controlled substance handling.
• Regional Manufacturing: Certain CMOs may manufacture in specific regions to meet local supply requirements, including North America, Europe, and Asia.

4. Distribution and Logistics

• Distribution Partners: UCB partners with global and regional logistics companies to ensure efficient, compliant distribution. This involves cold chain logistics and secure handling of controlled substances.
• Regulatory Compliance: Distribution channels follow strict regulatory guidelines for Controlled Substances Act (CSA)-regulated products, given fenfluramine’s past history as a controlled substance.

Regulatory and Supply Challenges

The reintroduction of fenfluramine under Fintepla has involved navigating complex regulatory frameworks of multiple jurisdictions:

• Controlled Substance Regulations: Fenfluramine is classified as a Schedule IV-controlled substance in the U.S., requiring specific handling procedures, secure storage, and reporting.
• Supply Limitations: Manufacturing capacity and raw material sourcing are challenges, especially given the need for high purity and safety standards.
• Supply Chain Disruptions: Global disruptions such as the COVID-19 pandemic have intermittently affected supply chains, emphasizing the importance of diversified manufacturing and logistics.

Emerging and Future Suppliers

As demand for Fintepla increases with expanded indications and market access, potential suppliers include:

• New Chemical Suppliers: Emerging companies with expertise in pharmaceutical-grade syntheses of fenfluramine precursors.
• Innovative CMOs: Organizations investing in specialized manufacturing processes suited for controlled substances and high-potency APIs.
• Regional Manufacturers: Localized suppliers in emerging markets to improve distribution and reduce dependency on a limited number of manufacturers.

Conclusion

The supply chain for Fintepla hinges on UCB’s strategic oversight, encompassing manufacturing of high-purity API, raw material procurement from specialized chemical suppliers, utilization of CMOs for scalable production, and adherence to regulatory frameworks for distribution. As demand evolves, diversification in suppliers and manufacturing capabilities will be critical to ensuring consistent global availability.

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Key Takeaways

• UCB is the primary license holder responsible for manufacturing and distributing Fintepla globally.
• Raw material suppliers provide high-quality chemical precursors adhering to GMP standards to ensure API purity.
• Contract Manufacturing Organizations (CMOs) facilitate scalable production, particularly for sterile and high-potency formulations.
• Navigating regulatory classifications as a controlled substance presents logistical and compliance challenges.
• Future supplier diversification and regional manufacturing can strengthen supply resilience amid increasing demand.

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FAQs

1. Who manufactures Fintepla?
UCB holds the manufacturing rights for Fintepla, producing the API and overseeing global distribution. They partner with CMOs for large-scale production.

2. Are there alternative suppliers for fenfluramine raw materials?
Currently, raw material sourcing is limited to select chemical manufacturers qualified by UCB, but ongoing efforts may introduce new suppliers to enhance capacity.

3. How do regulatory controls impact the supply chain?
Fenfluramine’s classification as a Schedule IV-controlled substance requires secure handling, strict documentation, and compliant logistics, which can limit supply flexibility.

4. Have supply disruptions affected Fintepla availability?
Global events like the COVID-19 pandemic temporarily impacted manufacturing and distribution, highlighting the need for diversified supply sources.

5. Is it possible for regional manufacturers to produce Fintepla?
Yes, with appropriate licensing, regulatory approval, and GMP compliance, regional manufacturers could enter the supply chain to bolster availability.

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Sources:

1. UCB official website and press releases [1]
2. FDA drug approval documentation for Fintepla [2]
3. WHO guidelines on controlled substances [3]
4. Industry reports on pharmaceutical supply chains [4]
5. Public filings and licensing agreements related to fenfluramine manufacturing [5]