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Suppliers and packagers for fintepla
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Fintepla (fenfluramine) Suppliers Map: What companies supply API, finished-dose manufacturing, and distribution for the drug
Fintepla (fenfluramine) is supplied in the US by Zogenix, Inc. (now part of Takeda) and is manufactured by multiple contract manufacturers depending on the dosage form and packaging configuration. The supplier landscape is anchored by (1) the commercial holder for US launch and distribution and (2) a typical multi-site CDMO model for solid oral dose manufacturing and packaging.
Executive answer (high signal): the critical “supplier” nodes for Fintepla are (a) the commercial rights holder/distributor (Takeda/Zogenix) and (b) the contract manufacturing and packaging network for fenfluramine HCl tablets and their marketed packaging formats.
Who supplies Fintepla (fenfluramine) in the US market?
Featured snippet:
- Commercial/distribution supplier (US): Takeda / Zogenix (brand owner and US commercial operations following acquisition/transition).
- Manufacturing and packaging: contract manufacturers and packagers listed on FDA product labeling and submissions for Fintepla’s marketed NDC configurations.
What is the supplier model for Fintepla
Fintepla is a specialty oral antiepileptic product with controlled distribution and tight lot traceability. In practice, branded drug supply chains typically split into:
- Drug substance supply: fenfluramine API produced by one or more API manufacturers.
- Drug product supply: tablets manufactured by one or more sites under cGMP.
- Packaging and distribution: secondary packaging and NDC-level labeling performed by configured packaging partners.
For Fintepla, the “supplier” question resolves into those three nodes, with the commercial rights holder acting as the US distribution channel head.
What companies manufacture the Fintepla tablets (fenfluramine) as drug product?
Featured snippet: Fintepla tablet manufacturing is performed by FDA-registered contract manufacturing sites named in product-specific labeling and FDA submission chemistry/manufacturing sections for marketed dosage strengths and packaging NDCs.
Which dosage strengths drive different manufacturing/packaging configurations?
Commercial supply is organized around strength and packaging:
- tablet strength (fenfluramine HCl)
- bottle vs blister and the NDC-specific packaging
- lot release sites and QA release testing
Each configuration can map to different packaging partners even when the API and bulk tablet sites overlap.
Which companies supply fenfluramine API for Fintepla?
Featured snippet: Fintepla’s API supply is provided by fenfluramine API drug-substance suppliers disclosed through FDA filings and the drug product manufacturing chain for the marketed tablet.
How to identify the API supplier from public records
For branded specialty oral drugs like Fintepla, API suppliers are usually not listed on consumer-facing labeling. They are instead surfaced through:
- FDA CMC disclosures tied to the approved NDA
- inspection and establishment listings that align with drug-substance manufacture
- published supplier information in regulatory documents tied to manufacturing changes
The practical procurement implication is that API is a layered supply chain and often involves dedicated API manufacturing and subsequent purification and conversion steps to the salt form (fenfluramine HCl).
What does the FDA label say about Fintepla manufacturing and packaging?
Featured snippet: The US prescribing information and FDA-reviewed labeling identify the manufacturer/labeler and often references contract manufacturing responsibilities for production and distribution.
Where “supplier” information appears in the label
Key label fields that usually contain supplier-facing identifiers:
- “Manufactured for/Manufactured by” fields
- labeler and distributor listing in NDC directories
- contact and distribution statements tied to Takeda’s commercial operations
How do NDCs map to Fintepla suppliers (manufacturer and packager)?
Featured snippet: Each NDC can correspond to a different packaging configuration and, sometimes, a different packaging site even if tablet manufacture is shared.
Why NDC mapping matters for sourcing
If you are assessing supply continuity, recalls, or capacity constraints, NDC-to-site mapping is the fastest way to determine whether:
- the same tablet manufacturing site feeds multiple packagers, or
- the supply chain is split into regional or strength-based manufacturing routes
What supplier risks exist for Fintepla (fenfluramine) supply continuity?
Featured snippet: Supplier risk concentrates in the API and tablet manufacturing step and in the single or limited number of approved secondary packaging configurations for specialty branded products.
Common operational risk points
- API lot diversion and short-cycle manufacturing capacity
- tablet compression and coating batch failures
- packaging line constraints tied to NDC-specific configurations
- QA release timing and stability-limited shelf life constraints
What are the key suppliers for Fintepla in procurement and contracting terms?
Featured snippet: The contracting-relevant parties are:
- US brand owner/distributor (Takeda/Zogenix)
- drug product manufacturer(s) for marketed tablets
- packager(s) for NDC-level packaging
- API supplier(s) for fenfluramine HCl
How procurement teams structure supplier diligence
For each node, diligence typically covers:
- cGMP compliance and inspection history
- change control track record (CMC supplements)
- batch yield and stability performance
- capacity and redundancy across sites
Which suppliers support Fintepla globally (not just the US)?
Featured snippet: Global supply varies by territory because commercial rights and approved manufacturing sites differ by regulator. For Fintepla, territories generally use the branded holder’s distribution network plus country-specific importers and local distribution partners.
What changes by region
- local labeling requirements
- local importer of record
- packaging language and blister/bottle format requirements
- release testing and local batch documentation expectations
Key Takeaways
- Fintepla’s supply chain has a commercial/distribution center at Takeda/Zogenix and a multi-site manufacturing and packaging network for tablet production and NDC-specific packaging.
- The most actionable “supplier” entities for business decisions are the drug product manufacturer(s) and packager(s) tied to the NDC configurations, plus the API supplier(s) named in the NDA’s CMC documentation chain.
- Supplier risk is concentrated in the API and tablet bulk manufacturing steps and in limited packaging line configurations used for commercial NDCs.
FAQs
Who is the labeler or distributor of Fintepla (fenfluramine) in the US?
Fintepla’s US labeler/distributor is the brand owner for US commerce, Takeda (with Zogenix historical footprint).
Can different NDCs for Fintepla be supplied from different packaging sites?
Yes. NDC-level packaging configuration changes can map to different approved packaging facilities even if tablet manufacturing is shared.
How do I find the Fintepla tablet manufacturing site for my NDC?
Use the NDC and match it to FDA labeling and NDC directories that show the manufacturer/labeler fields and site-specific references tied to that configuration.
Who supplies the fenfluramine API used in Fintepla?
Fenfluramine API suppliers are disclosed through NDA CMC documentation and are reflected indirectly via the drug product manufacturing chain for the approved tablet strengths.
Are Fintepla suppliers different for international markets?
Yes. Approved manufacturing sites and local importers/distributors vary by regulator and territory, even when the same branded holder manages global commercialization.
References (APA)
- FDA. (n.d.). Drug approvals and labeling for Fintepla (fenfluramine). U.S. Food and Drug Administration.
- DailyMed. (n.d.). Fintepla (fenfluramine) prescribing information and labeler/distributor information. National Library of Medicine.
(No further sources can be listed without exact FDA/NDC/labeler entries for the marketed configurations.)
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