Last updated: April 24, 2026
Who Supplies Alunbrig (brigatinib) Inputs and Manufacturing?
What companies supply Alunbrig (brigatinib) at the drug-product level?
Alunbrig is marketed by Takeda Pharmaceuticals. Public records and regulatory submissions identify a supply chain that spans: (i) drug substance (brigatinib) manufacturing, (ii) drug product (Alunbrig tablets) manufacturing, and (iii) packaging/labeling. Supplier identity is confirmed through regulator-facing manufacturing-site disclosures, which typically name the responsible site(s) for manufacturing and packaging rather than every upstream chemical intermediate supplier.
Who is responsible for Alunbrig drug-product manufacturing?
Drug-product manufacturing for Alunbrig is carried out at contract manufacturing sites disclosed in regulatory filings. These are the suppliers that matter for supply continuity, quality system audits, and tech-transfer risk.
| Supply chain role |
Supplier (site-level) |
Evidence type |
What to watch |
| Drug product (tablet manufacturing) |
Disclosed manufacturing site(s) in regulatory submissions |
FDA/EMA labeling and product listings |
Site capacity, batch release location, change-control history |
| Packaging and labeling |
Disclosed packaging/labeling site(s) in regulatory submissions |
FDA/EMA product listings |
Serialization readiness, cold-chain (if any), packaging line downtime |
| Drug substance (brigatinib) |
Disclosed API manufacturing site(s) in regulatory submissions |
FDA/EMA product listings |
API source stability, impurity control capability |
Bottom line: For Alunbrig, the “suppliers” used in due diligence are the named API and tablet manufacturing sites plus packaging/labeling sites shown in regulatory manufacturing disclosures, with Takeda as the market authorization holder.
What suppliers make brigatinib (drug substance) used in Alunbrig?
Brigatinib drug substance is manufactured at one or more API manufacturing sites disclosed by the product authorization holder. These are the actionable suppliers for API supply continuity, long-lead ordering, and audit readiness.
| Supply chain role |
Supplier (site-level) |
Evidence type |
What to watch |
| Brigatinib drug substance (API) |
Disclosed API manufacturing site(s) in regulatory submissions |
FDA/EMA manufacturing disclosure lists |
DMF/CEP linkage, control strategy for impurities, API crystalline form control |
How do you map “suppliers” for Alunbrig to investable supply-chain risk?
For Alunbrig, supplier mapping should be handled at three layers that drive operational and compliance risk:
- API site(s) (brigatinib): drives the longest lead times and highest process-knowledge sensitivity.
- Tablet site(s) (Alunbrig tablets): drives compression/coating and finished-dose defect risk.
- Packaging/labeling site(s): drives market readiness, serialization, and right-first-time distribution.
What is the role of Takeda vs. manufacturing suppliers?
- Takeda is the market authorization holder/labeler in major markets, and it files submissions that identify the manufacturing sites used for both drug substance and drug product.
- Manufacturing suppliers are the contract manufacturing and packaging sites named in those submissions and product listings.
Key Takeaways
- “Suppliers for Alunbrig” should be mapped to named regulatory manufacturing sites for API (brigatinib), drug product (Alunbrig tablets), and packaging/labeling, with Takeda as the market authorization holder.
- The most investable supply-chain inputs are API sites and finished-dose manufacturing sites disclosed in regulatory manufacturing lists, because these determine continuity, batch-release readiness, and change-control risk.
- Supplier diligence should focus on site-specific issues: capacity, batch-release location, GMP compliance history, serialization capability, and tech-transfer status.
FAQs
1) Who is the marketing authorization holder for Alunbrig?
Takeda Pharmaceuticals.
2) What do “suppliers” mean in the context of Alunbrig?
They are the named regulatory manufacturing sites that produce brigatinib API, manufacture Alunbrig tablets, and perform packaging/labeling.
3) Are there multiple suppliers for Alunbrig manufacturing?
Regulatory submissions often disclose more than one site across API, finished dose, and packaging/labeling depending on market and stage of manufacturing.
4) What matters most for supply continuity: API or tablets?
API (brigatinib) sites usually matter most due to long lead times and higher process-knowledge sensitivity.
5) Where are Alunbrig manufacturing suppliers typically listed?
In regulatory product manufacturing disclosures (for example, FDA/EMA-associated listings) that name the manufacturing and packaging sites tied to the product.
References
[1] FDA. Drugs@FDA: Alunbrig (brigatinib). U.S. Food and Drug Administration.
[2] EMA. Alunbrig (brigatinib): EPAR product information and procedural documents (manufacturing and release information as published by EMA). European Medicines Agency.
[3] Takeda. Alunbrig (brigatinib) prescribing information and US product label content (labeler and referenced manufacturing/distribution details).
