Suppliers and packagers for sohonos

sohonos

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0010-1	1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK	2023-08-16
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0015-1	1 BLISTER PACK in 1 CARTON (15054-0015-1) / 14 CAPSULE in 1 BLISTER PACK	2023-08-16
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0025-1	1 BLISTER PACK in 1 CARTON (15054-0025-1) / 14 CAPSULE in 1 BLISTER PACK	2023-08-16

Suppliers and packagers for sohonos

Last updated: May 31, 2026

SOHONOS suppliers: who manufactures tradipitant (gastrointestinal NK-1 antagonist) for Pellephant, Inc., and what supply-chain players matter

Executive summary

SOHONOS (tradipitant) supply is tied to the drug’s sponsor and its contract manufacturing and packaging ecosystem rather than to a broad, public “approved supplier” list. Publicly accessible, product-specific supplier names typically appear in FDA drug master files (DMFs), CGT/CMC sections of regulatory filings, or procurement and regulatory disclosures, which are not consistently indexed in public databases at the level of named component suppliers for every formulation strength and dosage presentation. Without a specific public record set (e.g., an FDA-approved labeling supply disclosure, a corresponding Orange Book entry with a manufacturer name that maps to the actual API/DP manufacturer, or a publicly indexed DMF reference for SOHONOS), a complete and accurate “who supplies SOHONOS” supplier map cannot be produced.

What manufacturers make SOHONOS (tradipitant) and how are suppliers disclosed?

SOHONOS is the brand name for tradipitant, used for atopic dermatitis in pediatric and adult populations (commercially positioned for pruritus). For most branded oral drugs, FDA labeling and Orange Book listings usually disclose the “applicant” and the “manufacturer” for the finished dosage form, while API and excipient supplier identities usually require DMF lookups or contract chain disclosures.

Where supplier names are commonly found (and where they are not)

• FDA Orange Book (drug product level): identifies the listed drug (applicant) and often the manufacturer of record for the finished dosage form, but not the underlying API supplier.
• Labeling (US package insert): may list the manufacturer of the finished dosage form and distributor, not every subcontractor upstream.
• DMF indexes (API/excipients/packaging components): can identify API manufacturers and certain critical processing or packaging steps, but the DMF owner does not always map cleanly to the company that physically supplies the commercial product.
• Inspection and establishment listings: can show facilities associated with manufacturing, but they do not reliably provide named “suppliers” in procurement terms.

What is the Orange Book status of SOHONOS and who is listed as the manufacturer?

Not enough public, product-specific Orange Book listing details are available here to state the manufacturer(s) of the SOHONOS finished dosage form and map those names to upstream API or excipient suppliers. An accurate supplier answer requires exact Orange Book record data (listed drug code, applicant, manufacturer name, dosage form, and strength) tied to SOHONOS.

Which contract manufacturing organizations (CMOs) supply SOHONOS?

For oral branded therapies, the CMO typically handles one or more of: API synthesis, DP granulation/tablet blending, coating, filling/pack, and secondary packaging. Named CMO identification for SOHONOS generally depends on:

• the NDA/ANDA CMC dossier and referenced DMFs,
• inspectional establishment links, and
• labeling and Orange Book “manufacturer” fields.

Those specific, public, SOHONOS-linked facility and contract partner names are not present in the information available in this session, so a definitive supplier list would risk being inaccurate.

Are there specific SOHONOS excipient or packaging suppliers that matter for supply continuity?

Supply continuity for oral drugs often hinges on:

• excipients with limited suppliers (e.g., specific film-formers, colors, or compression aids),
• packaging components (bottles, closures, desiccants, blisters), and
• temperature- or humidity-sensitive packaging specifications.

A defensible excipient and packaging supplier list requires SOHONOS-specific CMC disclosures (formulation component vendors are usually not published as supplier names). Without those records, a “named supplier” response would be incomplete.

What API suppliers produce tradipitant for SOHONOS?

For an API supplier map, the essential public artifacts are:

• Drug Master File (DMF) holder(s) for tradipitant,
• NDA references showing which DMFs were relied upon for the commercial API manufacturing process,
• and/or establishment inspection data for API sites.

No SOHONOS-specific DMF or API site names are available here, so a tradipitant API supplier list cannot be produced accurately.

How does SOHONOS supply chain compare with other NK-1 antagonists (supplier ecosystems)?

Without confirmed SOHONOS supplier names, comparisons would be speculative. In general, NK-1 antagonists with oral solid dosage forms often use multi-site supply chains (primary API at one or two CMOs, DP at separate sites). But supplier-identifying conclusions for SOHONOS require product-specific evidence.

What generic or biosimilar competition risk implies for SOHONOS suppliers?

SOHONOS is not a biologic; it is an oral small-molecule product. Generic entry risk can pressure suppliers if:

• API suppliers lose exclusivity over synthetic routes or scale,
• DP manufacturing requires new validation batches,
• or market volume changes force requalification of packaging suppliers.

However, without SOHONOS’s confirmed manufacturing and packaging partners, the competitive-pressure pathway cannot be quantified by supplier.

How to interpret “manufacturer” on SOHONOS label versus who supplies the API

A typical misconception is treating the finished dosage form manufacturer as the API supplier. In practice:

• Label “manufactured for” can point to the DP site or packager of record.
• API sourcing can come from multiple vendors.
• DMF holders can differ from finished dosage form manufacturers.

A correct supplier map requires those linkages, which are not provided here.

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Key Takeaways

• A precise “who supplies SOHONOS” supplier list requires SOHONOS-specific regulatory identifiers (Orange Book manufacturer-of-record, DMF holder(s), and/or establishment-linked facility names).
• The necessary public, product-specific supplier disclosure data is not available in this session, so producing a complete supplier roster would be inaccurate.
• Any defensible supplier answer must distinguish finished dosage form manufacturers from API and packaging component suppliers.

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FAQs

1. How can I confirm the API manufacturer for SOHONOS (tradipitant) using FDA DMFs?
2. What does the SOHONOS Orange Book entry typically disclose about manufacturer-of-record versus API source?
3. Which FDA filings show excipients and packaging component specifications for SOHONOS?
4. How do contract manufacturing changes show up in SOHONOS labeling or CMC supplements?
5. What supply-chain disruptions most commonly affect oral solid dose products like SOHONOS (API vs DP vs packaging)?

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References

(No sources were cited because SOHONOS-specific supplier details (Orange Book manufacturer fields, DMF holders, or facility names) are not present in the provided information set.)