Which company makes the futibatinib active pharmaceutical ingredient (API)?
Futibatinib is an investigational/marketed small-molecule drug developed by Taiho Oncology (a part of Taiho Pharmaceutical) and marketed in some regions under the brand Ayvakit. However, the specific contract manufacturing company (CMO) that produces the futibatinib API can change over time and is not consistently listed in public sources as a single, permanent supplier. Public drug listings and regulatory records often name the sponsor/MAH rather than the exact API producer.
What are the most reliable ways to identify the specific API manufacturer?
If you need the actual API manufacturing company (not the brand owner), the most dependable public sources tend to be:
- The drug’s regulatory dossier information where available (e.g., FDA/EMA submissions and labeling-type documents that sometimes name manufacturing sites, though API-specific attribution is not always explicit).
- Inspection databases and enforcement actions that list manufacturers and sites (where they exist for the relevant jurisdiction and time period).
- Supplier-change announcements and quality documentation tied to specific production lots or filings (often not fully public).
Is “API manufacturer” the same as “drug manufacturer”?
No. The company that manufactures the finished dosage form (tablets/capsules) is not necessarily the same as the company that produces the API. Many drugs use contract manufacturing for the finished product, while API may come from a different upstream CMO. Public-facing information more commonly identifies the finished-product manufacturer or the marketing authorization holder (MAH) than the upstream API site.
If you’re trying to source futibatinib API, what details should you confirm?
For procurement or research use, you typically need to verify:
- The exact grade (e.g., research vs. GMP API)
- Intended regulatory status (GMP for clinical vs. commercial use)
- Whether the supplier provides CoA/CoC, synthesis route, impurity profile, and traceability
- Batch-to-batch consistency and stability/hold-time requirements
Can you tell me your use case so I can narrow the answer?
If you share which you mean by “manufacturing company,” I can tailor the search path:
- Are you looking for the company that manufactures the API for the marketed drug (GMP API)?
- Or are you looking for contract suppliers that can sell futibatinib API for lab/analytical work?
- Which country/region (US, EU, China, India) matters for regulatory-site identification?
If you tell me the region and whether this is for procurement or regulatory attribution, I can give a more precise, actionable answer based on the relevant public sources.