Last updated: June 1, 2026
AZASAN (azathioprine) Suppliers and Manufacturing Sources: Who Makes It, Who Supplies API, and What Are the Supply-Chain IP Barriers?
AZASAN is the brand name for azathioprine (an immunosuppressant; thiopurine). No validated, complete supplier list is available from the information provided.
Which companies supply AZASAN (azathioprine) in the US and EU?
AZASAN supply depends on (1) the labeled manufacturer/distributor for each market and (2) the API source for azathioprine, which is typically provided through contract manufacturing and regulated supply chains.
No confirmed market-specific supplier roster (US labelers, EU marketing authorization holders, or authorized distributors) is present in the provided material, so a complete answer cannot be produced.
Who supplies azathioprine API for AZASAN tablets/capsules?
Azathioprine API sourcing is handled through qualified suppliers and DMFs/ASMF systems. A verified mapping of API manufacturers to AZASAN cannot be generated without linkage data (FDA drug product listing, Orange Book/NDC-level labeler, or EU dossier/EMA sources).
What is the FDA Orange Book status of AZASAN and how does that identify suppliers?
Orange Book entries can identify the listed drug and sometimes the applicant/holder tied to the regulatory listing, which helps map to labelers and authorized manufacturers.
No Orange Book record details were provided, so the supplier-identification workflow cannot be executed.
How many manufacturing sites make AZASAN, and what are the typical CMO/CMG patterns?
Where AZASAN is supplied through multiple sites, patterns are usually:
- primary site for commercial bulk
- secondary site for packaging/labeling
- possible alternative API supply chains
A quantified count of sites and naming of CMOs/packagers requires drug listing and manufacturing disclosure that is not present.
Which generic or alternative azathioprine products compete with AZASAN supply?
Competition in azathioprine is often via:
- generics under ANDAs
- pharmacy-led substitutions across NDCs
A competitor mapping requires the relevant reference product and approved generic inventory for each market, which is not included in the provided content.
What are the key IP or regulatory supply-chain barriers for AZASAN?
For supply constraints, the main levers are:
- patents and exclusivities listed for the reference product
- manufacturing controls and facility inspections
- REMS (if applicable; none is known from provided inputs)
- DMF/ASMF reliance for API
No patent or exclusivity record is provided, so barriers cannot be stated as facts.
How do you identify the true supplier of AZASAN in each NDC?
A correct approach uses:
- FDA NDC directory to identify labelers
- FDA drug product listing to connect labelers to manufacturing sites
- Orange Book “Applicant/Patent Holder” fields to tie to regulatory owners
No FDA/NDC data is present, so supplier identification cannot be completed.
What logistics and distribution model typically supports AZASAN availability?
Typical models include:
- wholesaler distribution
- direct accounts via GPO and specialty channels (depending on product classification)
- staggered lot release via QC testing schedules
A market-specific AZASAN distribution model cannot be derived from the provided information.
Key Takeaways
- AZASAN is azathioprine.
- A verified list of suppliers (API and finished dose manufacturers) for AZASAN cannot be produced from the information provided.
- Supplier identification requires market-specific labeling/regulatory listing data that is not included here.
FAQs
- How do I find the manufacturer behind my specific AZASAN NDC?
- Do AZASAN shortages come from API supply constraints or finished-dose manufacturing?
- Are there multiple API suppliers for azathioprine used by AZASAN labelers?
- Which regulatory filings (DMF/ASMF/ANDA) most often reveal azathioprine supply sources?
- How can Orange Book and FDA listing fields be combined to trace AZASAN supply-chain ownership?
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- FDA. NDC Directory.
- FDA. Drug Product Listing (DPL).
