Last updated: May 30, 2026
Fentanyl-100 (fentanyl citrate) Suppliers: Who Manufactures, Where Sourced, and What IP/Regulatory Constraints Affect Supply
FENTANYL-100 is a fentanyl citrate product used for controlled opioid therapy. Identifying “suppliers” requires anchoring to the specific FDA-listed drug product, strength, and dosage form. With only the label “FENTANYL-100” provided and no FDA National Drug Code (NDC), dosage form (tablet, patch, lozenge, injectable), or manufacturer/labeler specified, a complete supplier map cannot be produced without risking incorrect attribution.
Which companies supply fentanyl citrate products in the US (NDC-based sourcing)?
The most reliable supplier list in US procurement is built from the FDA National Drug Code Directory and the Orange Book record for the exact dosage form/strength. “FENTANYL-100” is not a unique identifier on its own for sourcing because fentanyl is marketed under multiple dosage forms and strengths, with different labelers and manufacturing sites.
What determines who qualifies as a “supplier” for fentanyl?
Common procurement definitions include:
- Labeler/Applicant on the FDA listing (who the FDA considers responsible for the drug product)
- CMO/manufacturing site (who physically produces batches)
- Wholesaler/distributor of record (who sells through distribution channels)
Each can differ across dosage forms (for example transdermal systems versus immediate-release oral products).
How dosage form changes the supplier set
Fentanyl’s supplier ecosystem differs by:
- Transdermal patches (often polymer system-specific manufacturing)
- Oral transmucosal systems (unit-dose, transmucosal delivery)
- Injectables (sterile manufacturing, aseptic controls)
Without the dosage form tied to “FENTANYL-100,” the supplier list cannot be accurately bounded.
What is the Orange Book status of fentanyl products (and does it limit generic supply)?
Orange Book exclusivity and patent status matter only when multiple FDA-approved versions compete for the same active ingredient, dosage form, and strength. For fentanyl, many products face tight regulation and controlled substance handling, but the controlling question for supplier mapping is the exact FDA record.
Does generic entry depend on Orange Book listings for fentanyl?
Yes:
- If an Orange Book-listed reference product has unexpired patents, approved competitors may still exist via non-infringing formulations, different strengths, or different routes.
- For products without meaningful Orange Book patent barriers for a given dosage form, supplier count can be driven more by manufacturing capacity and controlled substance distribution licensing than by IP.
Without the exact FDA product, no valid Orange Book status can be assigned to “FENTANYL-100.”
When does fentanyl loss of exclusivity occur, and how does it change supplier availability?
Loss of exclusivity is product-specific. It depends on:
- Whether there are regulatory exclusivities (new chemical entity, new therapeutic biological product analogs are less applicable here)
- Whether there are patent estates for the exact formulation or method of use
A fentanyl supplier landscape changes at different times by dosage form and strength. “FENTANYL-100” does not supply enough specificity to compute any exclusivity or patent cliff.
What generic entry risks exist for fentanyl suppliers (Paragraph IV and litigation)?
Paragraph IV challenges apply to ANDA products against Orange Book patents for the reference listed drug. For fentanyl supply planning:
- The key risk is whether competitors can obtain ANDA approval for the exact dosage form and strength without patent infringement.
- In practice, controlled substance supply can still lag even after approval due to manufacturing and DEA-regulated distribution constraints.
A litigation and Paragraph IV map cannot be built without the reference product, strength, and dosage form tied to “FENTANYL-100.”
Which manufacturing sites and CMOs support fentanyl supply (sterile vs non-sterile)?
Supplier sourcing in fentanyl frequently involves:
- Sterile injectable manufacturing (aseptic fill-finish, terminal sterilization)
- Non-sterile solid oral manufacturing (tablet/capsule, lozenge)
- Transdermal patch manufacturing (layered assembly, controlled release accuracy)
The manufacturing supplier list is dosage-form-specific and can be read from:
- FDA facility listings tied to the NDA/ANDA
- Labeler and manufacturing descriptions on the FDA NDC Directory
“FENTANYL-100” alone does not indicate which manufacturing class applies.
How to build an actionable supplier roster for FENTANYL-100 procurement
A defensible supplier roster is built on three identifiers:
- Active ingredient and salt (fentanyl citrate or base)
- Dosage form and strength (what “100” denotes)
- FDA product identity (NDC and labeler/manufacturer)
From there, the supplier roster should be generated from:
- FDA NDC Directory: labeler(s), packaging, and product identifiers
- Orange Book: reference listed drug match, patent status, and exclusivity
- FDA inspections/facility information: manufacturing site-level supply reliability
No valid roster can be produced from “FENTANYL-100” without those anchors.
Key Takeaways
- “FENTANYL-100” is not a unique, FDA-anchored identifier for compiling a correct supplier list.
- Fentanyl supplier landscapes are dosage-form and strength-specific and require FDA product identity (NDC) to map labelers and manufacturing sites.
- Orange Book and patent-driven generic entry only apply once the exact reference product is identified.
FAQs
- What is the fastest way to identify legitimate suppliers for fentanyl in US distribution?
- How do dosage form and strength change the fentanyl supplier base?
- Does Orange Book status materially affect fentanyl supplier availability?
- How do DEA controlled substance distribution requirements impact supplier onboarding?
- What manufacturing risks most affect fentanyl supply continuity (sterile vs patch)?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. National Drug Code Directory. U.S. Food and Drug Administration.
