Suppliers and packagers for generic pharmaceutical drug: FENFLURAMINE HYDROCHLORIDE

FENFLURAMINE HYDROCHLORIDE

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 Fenfluramine Hydrochloride (Fintepla): API and Drug-Product Sources, Contract Manufacturing, and Supply-Side IP Barriers

Last updated: May 26, 2026

Fenfluramine hydrochloride supply is dominated by the original branded program behind Fintepla (fenfluramine). For procurement planning, investors, and launch-gap risk assessment, the key supply-side variables are: (1) who manufactures fenfluramine API, (2) who produces and packages fenfluramine HCl drug product, and (3) whether any contract manufacturing organization (CMO) arrangements constrain substitution during shortages, inspections, or post-approval lifecycle changes.

Who are the key suppliers of fenfluramine hydrochloride (Fintepla) in the US market?

Fenfluramine hydrochloride is marketed as Fintepla in the US and is subject to tight distribution controls typical for a specialty, REMS-like ecosystem (even when not marketed under a full REMS label, distribution and compliance processes still apply).

Core supplier categories

• Brand sponsor / NDA holder: the company responsible for regulatory submissions, labeling, and supply oversight.
• API manufacturers: suppliers of fenfluramine (active ingredient) in hydrochloride salt form or intermediate steps leading to the hydrochloride salt.
• Drug-product manufacturers: CMOs or in-house sites producing the oral solution dosage form and packaging into finished presentations.
• Packaging and label suppliers: primary packers, secondary packaging sites, and serialization-capable operations.

Supply-side procurement reality

• For specialty products like Fintepla, substitution risk typically comes from API lot variability, specialized analytical control methods, and regulatory change-management requirements for manufacturing site changes. This is where “supplier” can mean more than one legal entity, even when final drug product is sold under a single brand.

Which companies manufacture fenfluramine API and fenfluramine hydrochloride salt?

API and salt manufacturing for fenfluramine is typically performed by a small set of qualified manufacturers because:

• the molecule requires controlled synthesis and impurity management,
• the salt form demands specific crystallization and drying parameters,
• cGMP validation and ongoing stability/impurity monitoring are non-trivial.

What to look for in procurement due diligence

• FDA Drug Master File (DMF) linkage to the NDA/BLA submissions (where applicable)
• US cGMP inspection history for the named manufacturing site(s)
• evidence of tech transfer capability for orphan/specialty lifecycle changes
• ability to support commercial scale plus stability and change-control documentation

Actionable supply mapping The procurement-grade supplier list for fenfluramine hydrochloride is derived from:

• FDA labeling/manufacturing sections that name the responsible site(s) for drug product,
• the NDA’s listed manufacturing/packaging locations,
• DMF holders and API manufacturing sites referenced in regulatory filings.

No complete and accurate public supplier roster is producible here without a specific, citable source list of API sites and finished-dose manufacturers. This response therefore focuses on what can be stated precisely at the business-decision level: Fenfluramine hydrochloride supply is brand-controlled and routed through a limited set of qualified API and CMO drug-product sites, with switchability constrained by CMC change-control and comparability requirements.

Which firms supply the fenfluramine hydrochloride drug product (Fintepla oral solution) under cGMP?

Drug product supply for fenfluramine hydrochloride (Fintepla) is concentrated in manufacturing networks that can support:

• oral solution production,
• multi-step sterile-not-applicable but high-purity liquid handling,
• container closure integrity and stability,
• batch release testing with validated methods for fenfluramine and impurities.

Procurement risk factors for drug product sourcing

• viscosity and dissolution behavior controls,
• preservative system compatibility (if present in formulation),
• container closure system performance,
• lot-to-lot analytical consistency and stability timepoints.

Commercial sourcing reality If you are trying to qualify alternate suppliers, the gating item is not whether a CMO can make “a fenfluramine oral solution,” but whether the CMO can make it under:

• the original regulatory quality system,
• approved specifications and validated analytical methods,
• a comparability and change-control path that satisfies FDA expectations.

How do contract manufacturing and packaging supply chain constraints affect fenfluramine availability?

CMO and packaging constraints can drive supply gaps even when API supply exists. For fenfluramine hydrochloride, the typical friction points are:

• Analytical release capacity: specialized release panels for fenfluramine and impurities.
• Stability program load: each supply site swap needs stability continuation with defined acceptance criteria.
• Serialization and distribution readiness: packaging lines must be able to support compliant distribution.
• Batch scheduling: specialty drug products can have long changeover and containment requirements that limit throughput.

What buyers should treat as “single points of failure”

• the fill-finish or liquid filling step,
• the primary packaging/closure supplier qualified for container closure integrity,
• the site performing final labeling/serialization.

What patents restrict alternative suppliers of fenfluramine hydrochloride?

Supplier switching in small-molecule specialty markets is often limited less by chemistry know-how and more by:

• process patents that cover critical intermediates or salt formation steps,
• formulation patents that cover oral solution composition and/or stability approaches,
• method-of-use patents that cover dosing regimens and therapeutic use (less relevant to manufacturing, more relevant to competition and generic entry).

Fenfluramine IP barrier map (decision-level)

• If any active patents protect fenfluramine hydrochloride manufacturing or key intermediates, alternative API sourcing may trigger infringement risk or force licensing.
• If formulation patents protect the oral solution, alternative fill/finish or product manufacturing must avoid patented composition or secure a license.

This response cannot list specific fenfluramine hydrochloride patents, numbers, assignees, or expiration dates without a citable patent record set. A complete patent estate list is required to support litigation and design-around planning.

What is the Orange Book status of fenfluramine hydrochloride, and does it affect suppliers?

For supplier planning, Orange Book listings matter because they define whether generic or AB-rated product entry is possible and what patent barriers exist. Those barriers also shape when alternate manufacturing capacity may be relevant.

No complete Orange Book status table (listed patents, expiration dates, and listed drug details) can be generated here without a citable Orange Book record.

What generic entry risks exist for fenfluramine hydrochloride that could change supplier lists?

Generic-entry timing affects supplier ecosystems by:

• bringing in additional API manufacturers,
• unlocking alternative CMO capacity,
• enabling parallel supply routes.

Where generic entry risk concentrates

• patent expiration timing for listed compositions and methods,
• risk created by Paragraph IV challenges,
• settlement agreements that delay or foreclose entry.

No Paragraph IV or settlement dataset can be produced here without a citable litigation docket or FDA ANDA/P-IV record.

Which countries are typical sources for fenfluramine hydrochloride API and finished product?

Specialty small-molecule APIs often come from:

• India, China, and parts of Europe for API,
• US/EU for finished-dose packaging under tight quality agreements.

Supplier qualification is the constraint Country is less relevant than:

• site cGMP quality,
• DMF documentation completeness,
• ability to pass FDA inspections,
• consistent impurity profiles over commercial runs.

Without citable manufacturing location data tied to fenfluramine HCl, a country-by-country supplier roster cannot be asserted accurately.

How strong is the supplier base for fenfluramine hydrochloride given specialty dosing and limited CMO networks?

Supply-chain strength metrics to assess

• Number of qualified API sites
• Number of qualified drug-product sites
• Overlap between API and drug-product constraints
• Total batch capacity and lead times
• Regulatory change-control friction for site swaps

Business inference Fenfluramine’s specialty status generally correlates with a constrained qualified supplier list. The practical consequence is that supply disruptions are more likely to be driven by:

• batch release testing capacity,
• liquid manufacturing line availability,
• inspection outcomes at a single key site.

Key takeaways

• Fenfluramine hydrochloride supply is brand-controlled through a limited set of qualified API and drug-product manufacturing sites.
• Supplier diversification is constrained by cGMP qualification, impurity controls, and CMC change-control requirements.
• Procurement decisions should focus on finished-dose and packaging bottlenecks, not just API availability.
• A complete, supplier-by-supplier roster (API, CMOs, packaging sites) and an IP/patent barrier table require a citable regulatory and patent-record extraction to be accurate.

FAQs

1. What manufacturing steps for fenfluramine hydrochloride are most likely to be supply bottlenecks?
2. Do fenfluramine hydrochloride API suppliers need DMFs to be usable for US supply?
3. How does container closure system qualification affect fenfluramine oral solution sourcing?
4. What CMC documentation is required to qualify an alternate fenfluramine hydrochloride drug-product site?
5. How do fenfluramine patent expirations change the competitive landscape for suppliers?

References (APA)

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA Center for Drug Evaluation and Research (CDER). Drugs@FDA. U.S. Food and Drug Administration.
3. FDA. Drug Master Files (DMF) program information. U.S. Food and Drug Administration.