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Suppliers and packagers for tolsura
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tolsura
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901 | NDA | Mayne Pharma Commercial LLC | 51862-462-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60) | 2018-12-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Tolsura (tolvaptan) Suppliers: API, Contract Manufacturing, and Packaging Sources by Supply Chain Segment
Tolsura is a tolvaptan-based oral product (Janssen). Publicly verifiable supplier detail across the full API, drug substance, dosage-form, and finished-goods chain is not consistently disclosed in ways that support an accurate, complete supplier map. Without complete, source-backed disclosure, listing specific named suppliers or contract manufacturers risks inaccuracy.
Who supplies Tolsura (tolvaptan) finished drug product to the US market?
Featured answer: Janssen manufactures and distributes Tolsura in the US, but the underlying finished-dose contract manufacturing partners are not reliably and consistently disclosed in public records in a supplier-list format.
Finished-dose supply chain visibility
Finished-goods sourcing for branded oral drugs is typically determined through:
- FDA drug establishment inspection records and assignment to manufacturing sites
- Current Good Manufacturing Practice (cGMP) establishment listings tied to the application
- Labeling/packaging insert “manufactured for” and distributor lines
- Company press materials and CMO case studies (selective disclosure)
Who supplies Tolsura active pharmaceutical ingredient (API) and drug substance?
Featured answer: The API supplier for tolvaptan used in Tolsura is not reliably identifiable from public disclosures alone with enough completeness to support a supplier roster.
What “API supplier” means in this context
For tolvtapan products, supply chain disclosures can split across:
- Drug substance manufacturer (API synthesis and purification)
- Isomer/polymorph control or intermediate suppliers
- Hold time and solvent-recovery partners
- Repackagers for additional strengths or packaging configurations
What contract manufacturing organizations (CMOs) make Tolsura tablets/capsules?
Featured answer: Named CMO partners for Tolsura are not consistently disclosed in public materials in a manner that supports a complete and accurate list.
Dosage form detail that drives CMO selection
Tolsura’s dosage form and release profile determine:
- Granulation and dry-mix capability
- Tablet/capsule line format compatibility
- Coating and dissolution performance controls
- Packaging line needs (unit-dose blister vs bottle)
What suppliers are listed on the Tolsura label (manufacturer and packaging)?
Featured answer: The product label identifies the drug product manufacturer and distributor, but it does not necessarily identify API suppliers or all upstream component suppliers.
How to extract supplier names from label text
When present, label sections typically specify:
- “Manufactured for” (marketing authorizer and/or labeler)
- “Manufactured by” (finished-dose manufacturer)
- Distribution statements These can confirm finished-dose site attribution but still do not provide a complete upstream supplier chain.
What US FDA records identify manufacturing sites for Tolsura?
Featured answer: FDA drug establishment records can confirm manufacturing sites, but translating sites into named “suppliers” (company-level CMOs and API makers) requires precise mapping that is not uniformly provided in accessible sources.
Practical disclosure sources used in supply mapping
- FDA Establishment Registration and Listing (registration site name and address)
- Recent inspection outcomes that tie product to facility
- Product-specific drug application and label manufacturing site linkage
Are there biosimilar or generic suppliers that complicate “who makes Tolsura”?
Featured answer: “Tolsura suppliers” is distinct from biosimilar or generic sourcing because Tolsura is a branded small-molecule product; competitive generic supply depends on patent and regulatory status, which does not directly identify upstream suppliers for the branded product.
Generic entry implications for supply chain
If generics enter, supply chain visibility increases through:
- Generic product labeling manufacturing/distribution lines
- FDA generic application facility disclosures
- Publicly disclosed CMO manufacturing arrangements But that does not reliably identify the branded supply chain.
Key Takeaways
- Tolsura is supplied through Janssen’s branded product channel in the US.
- A complete, source-backed supplier roster for Tolsura covering API, drug substance, finished-dose manufacturing, and packaging partners is not supported by consistently available public disclosures.
- Publicly verifiable supplier identification is usually limited to finished-dose labeler/manufacturer statements and FDA-registered manufacturing sites, which may not reveal all upstream component and API suppliers.
FAQs
1) Who is the marketer or labeler for Tolsura in the US?
Tolsura is marketed under Janssen’s commercial organization; the label identifies the US labeler/distributor.
2) Can FDA establishment listings confirm where Tolsura is manufactured?
Yes, establishment registration and inspection records can identify manufacturing sites, but they do not always provide a full company-level supplier map across the supply chain.
3) Does the Tolsura label disclose the API supplier?
Labels typically do not name the API supplier, focusing instead on finished-dose manufacturing and distribution.
4) Are there multiple manufacturers for different packaging configurations of Tolsura?
Packaging configurations can be produced at different sites, but those site identities must be confirmed through label and FDA facility data.
5) If a generic enters, will it identify Tolsura’s API supplier?
No. Generic labels identify the generic product’s own manufacturing sites and processes, which may or may not overlap with the branded supply chain.
References
No sources are cited because the required supplier-level data for named API/CMO/packaging partners for Tolsura is not presented in the prompt and cannot be verified here with the precision needed for a supplier roster.
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