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Suppliers and packagers for tavalisse
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tavalisse
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299 | NDA | Rigel Pharmaceuticals, Inc. | 71332-001-01 | 60 TABLET in 1 BOTTLE (71332-001-01) | 2018-05-09 |
| Rigel Pharms | TAVALISSE | fostamatinib disodium | TABLET;ORAL | 209299 | NDA | Rigel Pharmaceuticals, Inc. | 71332-002-01 | 60 TABLET in 1 BOTTLE (71332-002-01) | 2018-05-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for tavalisse
Tavalisse (fostamatinib) suppliers: manufacturing, API, and drug-product sourcing
Executive summary: Public, provable “supplier” detail for Tavalisse is limited to filings that name manufacturers for drug substance (API) and finished dosage (drug product) plus platform disclosures. Using FDA labeling and regulatory supply-chain disclosures that are actually identifiable in public records, Tavalisse is manufactured by Rigel Pharmaceuticals (or its authorized contractors) under the branded product program for fostamatinib. For drug-substance/API sourcing, only the drug-master-file (DMF) and CMC references identify specific API manufacturers in a way that can be tied to regulatory records, but those records are not fully enumerated in the open web. As a result, the “supplier” list that can be stated without overreach is confined to the entities explicitly shown in FDA labeling and regulatory documentation.
Who manufactures Tavalisse (fostamatinib) drug product?
Answer (drug product): Tavalisse is a branded fostamatinib product marketed in the US by Rigel Pharmaceuticals. Finished-dose manufacturing and release are performed by Rigel and/or its contract manufacturing network as referenced in US labeling and associated regulatory submissions.
US label identifiers for manufacturing and distribution
Tavalisse’s US prescribing information ties the product to Rigel’s branded supply chain and identifies responsible parties for manufacture and packaging in the “Manufactured for” and “Distributed by” sections.
Which suppliers provide fostamatinib API (drug substance) for Tavalisse?
Answer (API): API supplier identification depends on DMF-linked CMC sections and the specific manufacturing site(s) referenced in regulatory submissions tied to commercial lots. In publicly indexed FDA materials that are usually accessible, API manufacturer site names are commonly not fully enumerated in the open label text.
How API “supplier” is proven in regulated dossiers
In US practice, fostamatinib API suppliers are typically evidenced via:
- DMF listings and cross-references in the regulatory dossier
- Site-specific CMC content linked to marketed product manufacturing
- NDA/BLA supplements that add or change API manufacturing sites
Only those entities named in such regulatory references can be treated as definitive suppliers.
What is the Orange Book status of Tavalisse and what does it imply for sourcing?
Answer: Tavalisse is protected by a patent and exclusivity framework that does not directly determine the drug-product manufacturing suppliers, but it shapes the competitive landscape for authorized generics, manufacturing outsourcing, and any potential future generic procurement.
Why exclusivity matters for supplier decisions
When a brand has exclusivity:
- Purchases from authorized manufacturers remain focused on the brand’s commercial supply chain
- Any CDMO expansion is usually aimed at maintaining supply, not replacing suppliers
How many contract manufacturing organizations (CMOs) support Tavalisse supply?
Answer: Definitive enumeration of all CMOs is not possible from open label text alone. What can be stated is that commercial manufacturing is performed under Rigel’s branded program using authorized manufacturing sites referenced in labeling and regulatory materials.
Typical CMO roles in branded oncology/immune agents
For drugs like fostamatinib, the supply chain usually splits into:
- API synthesis and purification (drug substance)
- Film-coating and tableting or equivalent final dosage operations (drug product)
- Packaging and labeling (final release unit)
Which companies are in Tavalisse’s commercial supply chain vs. research supply chain?
Answer: The open-source “research” supplier set can differ from the “commercial” set, because:
- development lots may come from earlier synthesis routes and pilot-scale manufacturers
- commercial lots use validated routes and GMP sites
The only supplier set that is reliably attributable for “Tavalisse” as a marketed product is the commercial network referenced in labeling and regulatory filings.
Commercial-supply anchor
- Rigel Pharmaceuticals is the branded product sponsor and the anchor for commercial supply chain authorization.
What formulation and dosage form does Tavalisse ship under, and who supplies that process?
Answer: Tavalisse is an oral tablet product. The drug product manufacturing site for tablets and packaging is the supplier group referenced in the “Manufactured for” and related label sections.
Process implications for suppliers
Tablet programs require:
- validated blending and granulation
- tablet compression
- coating and QC release Suppliers who do tablet work are usually different from API suppliers.
What are the main manufacturing/IP barriers that limit switching Tavalisse suppliers?
Answer: The main barriers are not licensing-patent related at the supplier level. They are:
- GMP process validation across sites
- analytical method transfer and stability programs
- regulatory CMC commitments tied to the NDA
Why supplier switching is slow
Even without IP constraints, site changes require:
- comparability packages
- stability commitments
- updated batch release controls
What generic or biosimilar risk exists for Tavalisse that could change supplier demand?
Answer: Tavalisse is not a biologic, so the “biosimilar risk” framing does not apply. “Generic entry risk” is tied to:
- patent expiration and exclusivity windows
- FDA approval pathway timing
- Paragraph IV challenges (if any) and settlement outcomes
These factors influence procurement expectations but do not themselves name API or CMO suppliers.
Key Takeaways
- Drug-product manufacturing supplier(s): definitively attributable suppliers are those named in Tavalisse US labeling as manufacturers/packagers under Rigel’s branded program.
- API supplier(s): definitive naming generally requires DMF/CMC site references from regulatory dossiers, which are not fully enumerated in open label text.
- Supply-chain changes: switching drug substance or tablet-manufacturing sites typically faces GMP validation, analytical transfer, and regulatory CMC commitments.
FAQs
1) Who is the US sponsor of Tavalisse?
Tavalisse is sponsored by Rigel Pharmaceuticals in the US.
2) Is Tavalisse manufactured by the same entity that supplies fostamatinib API?
Usually no. API suppliers are commonly different from finished-dose manufacturers, and confirmation requires DMF-linked regulatory site references.
3) What document best identifies the finished-dose manufacturer for Tavalisse?
The US prescribing information sections that identify “Manufactured for” and related manufacturing/distribution language.
4) How do API supplier changes get approved for Tavalisse?
Through NDA CMC supplements supporting manufacturing site changes and comparability/stability.
5) Does patent status affect who can supply Tavalisse tablets or API?
Patents affect competitive manufacturing rights indirectly via market exclusivity, but actual supplier eligibility in GMP terms depends on regulatory CMC control and validation.
References (APA)
- Rigel Pharmaceuticals. (n.d.). Tavalisse (fostamatinib) prescribing information. U.S. Food and Drug Administration.
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Tavalisse/fostamatinib entries).
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