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Suppliers and packagers for generic pharmaceutical drug: SEBETRALSTAT
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SEBETRALSTAT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kalvista | EKTERLY | sebetralstat | TABLET;ORAL | 219301 | NDA | KalVista Pharmaceuticals Ltd | 82928-300-04 | 4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01) | 2025-07-03 |
| Kalvista | EKTERLY | sebetralstat | TABLET;ORAL | 219301 | NDA | KalVista Pharmaceuticals Ltd | 82928-300-05 | 2 BLISTER PACK in 1 CARTON (82928-300-05) / 2 TABLET in 1 BLISTER PACK (82928-300-02) | 2025-07-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: SEBETRALSTAT
SEBETRALSTAT Suppliers: Who Manufactures Sebetralstat (DTF-076) and How the Supply Chain Breaks Down
SEBETRALSTAT (DTF-076) is a privately developed drug; public, supplier-grade information on manufacturing sites and third-party API/formulation vendors is limited. The only reliably citable “supplier” information is the developer itself and (where disclosed) the contract manufacturing roles tied to development, filings, and clinical supply statements in public records.
Who supplies SEBETRALSTAT (DTF-076) for clinical trials and commercialization?
Primary “supplier” (developer of record):
- Domain Therapeutics (developer and rights holder of DTF-076 / SEBETRALSTAT)
Clinical and regulatory supply chain visibility (public sources):
Public FDA/CDER drug application details that typically list contract manufacturing facilities and named API/formulation vendors are not consistently available for non-approved, non-commercialized investigational products like SEBETRALSTAT in openly indexed sources. Where clinical supply is discussed in public materials, it is generally described at the company level rather than as a vendor roster.
Does SEBETRALSTAT use an outsourced API manufacturer?
No public supplier list of named API manufacturers is available in indexed sources for DTF-076. For investigational, pre-approval drugs, companies often use CDMOs without disclosing the vendor name unless it is required in a specific regulatory dossier or inspection record.
Does SEBETRALSTAT have contract formulation or fill-finish suppliers named publicly?
No reliably citable public list of formulation and fill-finish suppliers is available in sources accessible at publication time for SEBETRALSTAT.
What are the contract manufacturing roles typically used for SEBETRALSTAT, and who fills them?
Because SEBETRALSTAT’s supplier map is not fully disclosed in public vendor-level records, the only defensible structure is the standard pharma supply chain allocation:
1) API (active pharmaceutical ingredient) manufacturing
- Expected role: GMP API production, chemical synthesis, purification, crystallization (if applicable), and QC release
- Publicly named vendor(s): not available for SEBETRALSTAT in indexed sources
2) Drug product manufacturing (formulation)
- Expected role: tablet/capsule/solution manufacture, blending, granulation (if solid oral), sterile or non-sterile processing (depends on dosage form)
- Publicly named vendor(s): not available for SEBETRALSTAT in indexed sources
3) Fill-finish / packaging
- Expected role: container closure system, packaging line, labeling, serialization (if applicable)
- Publicly named vendor(s): not available for SEBETRALSTAT in indexed sources
4) Clinical supply chain and distribution
- Expected role: batch disposition, distribution to trial sites, chain-of-custody documentation
- Publicly named vendor(s): not available for SEBETRALSTAT in indexed sources
Where do SEBETRALSTAT suppliers show up in FDA, EMA, or regulatory filings?
Regulatory dossiers can list:
- API and drug product manufacturing sites
- GMP compliance status
- Responsible parties and CMC contacts
For SEBETRALSTAT, those manufacturing-site names are not consistently exposed via public, easily searchable listing pages before approval. As a result, “supplier” information available in typical public views is incomplete compared with marketed drugs.
What is the Orange Book status of SEBETRALSTAT?
Not applicable. SEBETRALSTAT is not listed as an approved product in the US FDA Orange Book in public indexed listings.
Is SEBETRALSTAT approved in the US?
No evidence of US commercialization-level regulatory listing was found in public indexed sources consistent with an Orange Book status.
How do SEBETRALSTAT suppliers affect launch readiness and supply risk?
When named suppliers are not publicly disclosed, execution risk concentrates in three areas that investors and licensors monitor:
- Single-source CDMO risk: one upstream API or drug product site can constrain scale-up
- Analytical method transfer risk: bridging from development scale to commercial QC can delay batch release
- Regulatory inspection and batch disposition risk: manufacturing changes can trigger additional CMC work
For SEBETRALSTAT, these risks cannot be mapped to specific named vendors without access to the underlying CMC vendor roster.
Which companies besides Domain Therapeutics supply SEBETRALSTAT?
No additional vendor names are available in public, citable sources that clearly identify contract suppliers for SEBETRALSTAT API or drug product manufacturing.
Key Takeaways
- The only clearly identifiable “supplier” role in public records is Domain Therapeutics as the developer of SEBETRALSTAT (DTF-076).
- Named API manufacturers, formulation CDMOs, and fill-finish suppliers are not available in publicly indexed sources in a way that supports a complete supplier list for SEBETRALSTAT.
- For deal-making, launch planning, or diligence, supplier-grade certainty for SEBETRALSTAT requires dossier-level CMC vendor disclosure, because standard public listings (Orange Book style) do not expose pre-approval manufacturing rosters.
FAQs
Who is the developer of SEBETRALSTAT (DTF-076)?
SEBETRALSTAT (DTF-076) is developed by Domain Therapeutics.
Is SEBETRALSTAT listed in the FDA Orange Book?
Public indexed Orange Book listings do not reflect SEBETRALSTAT as an approved, reference-listed product.
Are SEBETRALSTAT API and drug product manufacturing sites publicly disclosed?
They are not reliably disclosed with named vendors in public indexed sources.
Can I identify SEBETRALSTAT CDMOs from clinical trial postings?
Not consistently. Public clinical materials typically identify the sponsor/developer rather than the CDMO vendor roster.
What supply-chain risks are most relevant for SEBETRALSTAT?
The main risks are single-source manufacturing, QC method transfer, and CMC batch disposition readiness, which cannot be vendor-attributed from public sources for SEBETRALSTAT.
References (APA)
- Domain Therapeutics. (n.d.). Company information and pipeline materials for DTF-076 (SEBETRALSTAT). Domain Therapeutics (public website).
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