Last updated: May 24, 2026
INTUNIV (guanfacine) drug suppliers: API makers, finished-dose manufacturers, and key upstream contractors
Executive summary: INTUNIV (extended-release guanfacine) supply chains typically involve (1) an active pharmaceutical ingredient (API) guanfacine manufacturer or API repacker, (2) finished-dose manufacturers (tablet compression/coating, film coating, imprinting, packaging), and (3) packaging and logistics vendors. However, no complete supplier list can be produced from the information provided.
Who supplies INTUNIV (guanfacine ER) finished tablets in the US?
No supplier data is provided for INTUNIV’s finished-dose manufacturing, packaging, labeler, or distribution.
Does the labeler on the INTUNIV package identify the manufacturer?
No labeler/manufacturer identifiers (e.g., “Manufactured for…”, “Distributed by…”, NDC “Company Name” fields) are provided, so the finished-dose supplier cannot be mapped.
What roles exist in the INTUNIV supply chain?
Common roles that would be listed in regulatory and commercial artifacts include:
- API manufacturer (guanfacine)
- Drug product manufacturer (extended-release tablet)
- Secondary packager (bottling/blistering and cartons)
- Labeler/distributor (NDC label claim holder)
No such roles are supplied here.
Which companies make the INTUNIV (guanfacine) active pharmaceutical ingredient?
No API supplier names, DMF holders, or cross-referenced API manufacturing sites are included in the provided input, so API sourcing cannot be identified.
Are guanfacine ER APIs generally sourced from DMF-supported manufacturers?
Many API supply arrangements for US CNS products rely on DMFs or in-house production, but no INTUNIV-specific DMF references are provided, so this cannot be tied to named suppliers.
What upstream suppliers support INTUNIV extended-release coating and tablet manufacturing?
No manufacturing or site-level information is provided (drug master file references, CMO/contract manufacturer names, or facility addresses).
Which technologies drive INTUNIV ER tablet manufacturing?
INTUNIV is an extended-release tablet, implying controlled-release formulation and processing steps (granulation, compression, coating, dissolution control), but no process-supplier mapping is available from the provided input.
How can INTUNIV supplier networks be validated using regulatory filings and product labels?
No regulatory artifacts are supplied (FDA product label, Drugs@FDA listing, Orange Book references, or inspection records), so supplier validation cannot be performed.
Orange Book and labeling checks
Orange Book and label sections typically identify:
- Applicant/holder
- Listed patents (not supplier)
- Sometimes manufacturing statements
No Orange Book or label content is provided here.
FDA facility inspection records
Inspection records can reveal sites and product manufacturing, but no FDA inspection or establishment data is included in the input.
What is the supplier landscape for guanfacine ER tablets vs competing products?
A comparison requires a supplier list or at least the manufacturer/labeler data for:
- INTUNIV
- Generic guanfacine ER products
- Comparable ER alpha-2A agonists in the same class
No competitive product or supplier data is provided.
Key Takeaways
- Supplier identification is not possible from the provided information.
- INTUNIV supply chain mapping requires at minimum: US labeler/manufacturer or NDC “Company Name” fields and/or FDA/Orange Book/DMF-linked site data.
- No named API or finished-dose suppliers can be listed without source artifacts.
FAQs
- What does “INTUNIV” label text typically reveal about the finished-dose manufacturer?
- How do NDC labeler fields differ from actual drug product manufacturing sites?
- Which FDA databases are usually used to trace API and drug product suppliers?
- How do DMFs and site listings affect guanfacine API sourcing identification?
- What evidence is used to confirm contract manufacturers for extended-release tablets?
References
No sources were provided in the prompt.
