Last updated: April 23, 2026
Who Supplies Diflunisal APIs and Key Intermediates?
Diflunisal is a small-molecule NSAID (C12H8F2O2). It is typically supplied as an API by specialized generic API manufacturers and chemical producers that also supply key intermediates (notably difluorinated benzoic-acid and benzene-ring building blocks).
No complete, verifiable, up-to-date supplier roster for diflunisal API and intermediates is provided in the information available here. Without a cited manufacturer list from authoritative sources (e.g., FDA Orange Book manufacturer sections, EMA/EPAR manufacturer entries, USP/INN, European Medicines Agency registrations, DMF holders tied to diflunisal, or specific procurement catalogs), publishing supplier names would be non-actionable and risk inaccuracy.
What is the supplier landscape for diflunisal in regulated channels?
A regulated supplier landscape for an API is normally built from:
- Regulatory submissions tied to finished products (e.g., FDA Orange Book labeler/manufacturer entries for diflunisal products; DMF data for the underlying API).
- Chemical/intermediate supply chains supplying diflunisal’s core scaffolds (difluorinated aromatic intermediates) used by multiple API sites.
- Wholesale API distribution (parallel distribution and tender supply), which lists brand-level sellers rather than the true API site.
At present, the supplied context contains no named diflunisal API or intermediate suppliers, no DMF holder list, and no product-to-API mapping.
What suppliers are confirmed for diflunisal?
None.
No confirmed suppliers can be listed without authoritative, cited evidence tying specific manufacturer sites to diflunisal API or diflunisal key intermediates.
What categories of suppliers exist for diflunisal?
Even without names, diflunisal supply typically splits into three functional groups:
-
API manufacturers (finished API sites)
- Produce diflunisal (API) under cGMP and supply to generic finished-dose manufacturers.
- Often appear as API sources behind NDA/ANDA/authorized generic programs through Orange Book labeler or DMF linkage.
-
Intermediate producers (chemical synthesis sites)
- Supply diflunisal building blocks and difluorinated aromatic intermediates.
- The same intermediate suppliers can feed multiple NSAIDs and fluorinated aromatics.
-
API distributors
- Sell labeled API batches sourced from API makers.
- Distribution layers frequently change and do not reliably indicate the manufacturing site.
Key Takeaways
- Diflunisal API and intermediate supply exists through API manufacturers, intermediate producers, and distributors.
- A confirmed supplier list cannot be produced from the information provided here.
- For investment or sourcing work, the supplier set must be derived from regulatory and DMF-linked sources that explicitly identify diflunisal API manufacturers.
FAQs
1) Are diflunisal suppliers the same as diflunisal finished-dose manufacturers?
Not necessarily. Finished-dose labelers may source diflunisal API from multiple upstream API sites.
2) Can API distributors be treated as the manufacturer for sourcing?
No. Distributors typically resell sourced API and do not guarantee the manufacturing site.
3) What documents usually identify the true diflunisal API supplier?
API site identification is usually tied to regulatory submissions (Orange Book labeler/manufacturer entries and DMF-linked data) and registration documentation.
4) Do intermediate suppliers matter for diflunisal risk management?
Yes. Intermediate supply constraints can drive API lead times, pricing, and batch availability even when API capacity exists.
5) Is there a standard global supplier list for diflunisal API?
No single universally complete list exists; supplier rosters are built from product-level regulatory records and site-level submission data.
References
[1] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[2] U.S. Food and Drug Administration, Drug Master File (DMF) program background materials and regulatory framework.
[3] European Medicines Agency (EMA) product information and EPAR registration data (where applicable).
