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Suppliers and packagers for SOTYKTU
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SOTYKTU
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0895-11 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) | 2022-09-09 |
| Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0895-91 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91) | 2022-09-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for SOTYKTU
Who Supplies SOTYKTU (deucravacitinib) for Pharmaceutical Use?
SOTYKTU is deucravacitinib, an oral, selective TYK2 (tyrosine kinase 2) inhibitor. The commercial supply chain is dominated by the originator’s contracted manufacturing ecosystem and its downstream licensing and distribution arrangements. Public-domain supplier visibility is fragmented because key details (API sites, intermediate contractors, and packaging plants) are typically disclosed in product-specific regulatory submissions, contract manufacturing agreements, and country-level marketing authorizations rather than in a single consolidated list.
What supplier categories exist for SOTYKTU?
SOTYKTU’s supply chain breaks into four categories:
- API manufacturing (deucravacitinib drug substance)
- Drug product manufacturing (tablet formulation, compression, coating, packaging)
- Packaging and label/secondary packaging (bottling, blistering, carton labeling)
- Distribution and market supply (wholesale distribution networks by geography)
For business decisions, the actionable question is typically: which sites supply which markets and who manufactures at each stage.
Which named suppliers are publicly identifiable for SOTYKTU?
Public sources commonly identify:
- Company/brand owner: Bristol Myers Squibb (BMS) for SOTYKTU in major markets
- Manufacturer identifiers that appear on regulated product labeling (varies by country and presentation)
However, supplier-by-site (API plant names, specific CMO/contractor names for each step, and blister/bottle packager identity) is not consistently published in one place across jurisdictions. As a result, a complete “suppliers list” for all steps and all markets cannot be produced from a single publicly available dataset without risking incompleteness.
Given this, the only defensible “named supplier” statement from generally available public information is the commercial owner and the drug’s originator status.
Who is the commercial owner and marketer of SOTYKTU?
Bristol Myers Squibb is the branded product owner and marketer of SOTYKTU (deucravacitinib) in the United States and key global markets. The prescribing information identifies BMS as the manufacturer/marketer entity for the product label in the US context.
What can be stated with high confidence about SOTYKTU manufacturing structure?
Even without a complete global site list, the manufacturing structure for a branded small-molecule like deucravacitinib follows a predictable regulatory pattern:
- The API manufacturer supplies deucravacitinib drug substance under GMP to a drug product site.
- The drug product site formulates and manufactures tablets in GMP conditions.
- Secondary packaging (cartons, labels, bottle/blister packaging) is performed either at the drug product site or at a dedicated packaging plant under GMP oversight.
- Distribution then runs through authorized wholesalers and market-specific distribution partners.
This is the standard model for US/EU regulated small-molecule branded supply chains, and it matches how SOTYKTU is commercialized and maintained under ongoing regulatory compliance.
Are any major disclosed “supplier sites” available in open sources?
Open sources typically surface supplier identity in one of these ways:
- US FDA label and packaging (may show applicant/packager/manufacturer entities)
- Country-specific Summary Basis of Authorisation (SBA) / product registration documents
- EPAR/assessment reports (where available) for EU marketing authorizations
- Importation and marketing registration paperwork in specific countries
But those documents must be searched jurisdiction-by-jurisdiction and presentation-by-presentation to build a verified supplier table. A single consolidated “supplier list” for SOTYKTU cannot be constructed without pulling multiple country regulatory packages and aligning by presentation, strength, and packaging format (bottles vs blisters).
Key Takeaways
- SOTYKTU is deucravacitinib and is supplied through a standard GMP chain: API manufacturing → drug product manufacturing → packaging → distribution.
- Bristol Myers Squibb is the branded product owner/marketer for SOTYKTU in major markets.
- A complete supplier-by-site list (API and formulation/packaging contractors) is not available as a single consolidated public list; it is typically disclosed across country-level regulatory dossiers and product labeling and must be compiled from those sources.
FAQs
1) Who owns and markets SOTYKTU?
Bristol Myers Squibb is the SOTYKTU branded product owner/marketer in major jurisdictions. (See SOTYKTU prescribing information.)
2) Is SOTYKTU manufactured in-house by BMS?
SOTYKTU manufacturing uses the standard branded pharma model with contracted GMP suppliers for API and drug product steps; specific site ownership varies by market and is typically disclosed in country labeling and regulatory documentation.
3) Who supplies the API (deucravacitinib)?
The API is manufactured by GMP-qualified suppliers (API drug substance contractors or in-house plants depending on jurisdiction). Public disclosure of the exact API plant names is jurisdiction-specific.
4) Who supplies the tablets and packaging?
Tablet manufacturing and secondary packaging are performed under GMP by drug product manufacturing and packaging sites that may differ by market presentation.
5) How do I identify SOTYKTU suppliers for a specific country and presentation?
Use the local prescribing information/product labeling and the corresponding marketing authorization dossier for that country and strength/pack format, where the manufacturer and packager entities are typically stated.
References
[1] Bristol Myers Squibb. SOTYKTU (deucravacitinib) Prescribing Information (United States). U.S. FDA.
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