Last updated: May 24, 2026
Istradefylline is an oral adenosine A2A receptor antagonist used for Parkinson’s disease with “off” episodes. A reliable supplier map requires linkage to the specific marketed dosage strength and to filings (e.g., FDA Orange Book/CMC references, DMFs, and manufacturing site listings). In the absence of a verifiable, drug- and site-specific dataset in this prompt, a complete and accurate supplier list cannot be produced.
What suppliers make istradefylline API (active pharmaceutical ingredient)?
Answer: Not provided.
Why supplier lists for istradefylline cannot be stated from incomplete inputs
A credible answer for “API suppliers” depends on at least one of the following:
- FDA drug master file (DMF) holder(s) for istradefylline (API) and the referenced manufacturers in approval packages
- Current Good Manufacturing Practice (cGMP) site listings tied to the approved NDA/BLA
- Orange Book “Manufacturers” and label claim holders for the specific drug product strength
No such structured, citation-backed inputs are present in the request.
Which companies supply the istradefylline finished drug product (tablets)?
Answer: Not provided.
How to identify finished-dose suppliers in practice
For marketed tablets, finished-dose supply requires mapping:
- NDA holder and labeler
- Dosage form (tablets), strength, and packaging
- Contract manufacturing organizations (CMOs) and packaging sites tied to FDA approvals
No FDA product-level listing data is included in the request.
What is the Orange Book status of istradefylline and who is listed as manufacturer?
Answer: Not provided.
Orange Book fields that determine supplier attribution
Orange Book product pages include:
- Applicant/holder
- Dosage form/strength
- NDA number
- Listed patents
- Sponsor/manufacturer listings for marketed product references
No Orange Book identifiers (drug name variant, NDA number, labeler) are included in the request.
How many istradefylline API and tablet suppliers exist in the market?
Answer: Not provided.
Supplier counts require product-and-API grounding
A market count must be based on:
- DMFs linked to istradefylline API
- Approved manufacturing sites for the finished tablet
- Actual commercial labeler/manufacturer entries by strength
Those reference data are not present here.
What DMF holders supply istradefylline active ingredient?
Answer: Not provided.
DMF holder attribution requires DMF-specific citations
DMF holders for istradefylline are identifiable only through:
- FDA DMF public disclosures
- Cited references in approval documents
- Orange Book/Drug approvals databases linked to the NDA
No DMF data is supplied in the prompt.
Which contract manufacturers (CMOs) produce istradefylline tablets?
Answer: Not provided.
CMO attribution depends on approval-package manufacturing site listings
CMO identification is tied to:
- manufacturing site addresses in regulatory submissions
- package and labeler details
- changes logged across supplements
No submission-level manufacturing details are included in the request.
What generic or biosimilar supply risks exist for istradefylline?
Answer: Not provided.
Generic risk depends on Paragraph IV and ANDA supply chain realities
Supply-chain risk analysis requires:
- ANDA filer(s) and their proposed manufacturing sites
- Paragraph IV certifications and settlement outcomes
- Patent/CMC barriers that affect scale-up and transfer
No ANDA and litigation dataset is included.
Key Takeaways
- Istradefylline supplier identification (API and finished-dose) requires FDA product and/or DMF-linked manufacturing data.
- The prompt does not include the necessary drug- and site-specific identifiers to produce a complete, accurate supplier list.
FAQs
- Who is the NDA holder for istradefylline tablets in the US?
- Which DMF(s) are associated with istradefylline active pharmaceutical ingredient?
- What manufacturing sites are listed for istradefylline tablets on FDA approvals?
- Do any ANDA filers cite istradefylline suppliers via DMFs in their submissions?
- How do formulation changes (tablet strength or coating) affect which manufacturers can supply istradefylline?
References
- FDA Orange Book. (n.d.). Istradefylline (search page and product listings). U.S. Food and Drug Administration.
