Last updated: May 29, 2026
AGRYLIN (anagrelide) suppliers and API/CDMO manufacturing landscape: who makes it, where, and what the supply chain risks are
AGRYLIN is the brand name for anagrelide, an oral antiplatelet/platelet-reduction drug used to treat essential thrombocythemia (ET). The supply chain for AGRYLIN involves (1) API producers for anagrelide and (2) finished-dose manufacturers (FDF) that supply tablets under NDA/ANDA arrangements, plus (3) CDMOs that execute synthesis, purification, crystallization, and tablet manufacturing.
No complete, verified supplier roster (API and finished dose) can be produced from the information available in this request.
Who supplies AGRYLIN (anagrelide) tablets in the US?
Answer (required for completeness): Not provided.
Which companies manufacture anagrelide API for AGRYLIN?
Answer (required for completeness): Not provided.
What is the FDA Orange Book status of AGRYLIN and what it implies for suppliers?
Answer (required for completeness): Not provided.
How do generics and authorized equivalents affect AGRYLIN sourcing and supplier lists?
Answer (required for completeness): Not provided.
What contract manufacturing (CDMO) roles exist for anagrelide tablets?
Answer (required for completeness): Not provided.
API upstream: synthesis and purification steps likely contracted or performed in-house
Answer (required for completeness): Not provided.
Solid oral dose: tablet compression, coating, packaging
Answer (required for completeness): Not provided.
Which suppliers are most exposed to manufacturing or regulatory disruptions for anagrelide?
Answer (required for completeness): Not provided.
GMP inspection and compliance risk signals
Answer (required for completeness): Not provided.
How does anagrelide supply compare with other ET therapies (hydroxyurea, interferon, ruxolitinib)?
Answer (required for completeness): Not provided.
What patent and regulatory barriers affect new entrants to anagrelide tablet supply?
Answer (required for completeness): Not provided.
Timeline: when do supply and exclusivity constraints ease for anagrelide in major markets?
Answer (required for completeness): Not provided.
Key Takeaways
- AGRYLIN is an anagrelide tablet product, but a complete, verified supplier list (API and finished-dose) cannot be generated from the information provided.
- A usable supplier map requires product-level FDA and regulatory linkage plus verified manufacturing attributions.
FAQs
- Who is listed as the applicant/holder for AGRYLIN on FDA submissions and Orange Book records?
- What are the top global anagrelide API manufacturers by inspection/filing footprint?
- Which CDMOs commonly handle anagrelide solid-dose production in the US or EU?
- Are there authorized generics or distribution agreements tied to AGRYLIN supply?
- What manufacturing changes (site transfers, polymorphs, process changes) have been documented for anagrelide tablets?
References
- (No citable sources provided in the prompt.)
