Last updated: May 31, 2026
SYPRINE (Trientine) Suppliers: API, Contract Manufacturing, and Market-Channel Players
Executive summary: Syprine is trientine hydrochloride (active ingredient: trientine). Current supplier coverage hinges on the branded labeler’s supply chain (API makers, finished-dose manufacturers, and distribution partners) and on any Authorized Generic/market entries. No sufficiently specific, source-backed supplier list (company-by-company) can be produced from the information provided.
Who manufactures SYPRINE (trientine hydrochloride) tablets in the US?
A complete, accurate answer requires tying Syprine to (1) the FDA label holder/marketing authorization, (2) the listed manufacturer(s) on the US label, and (3) the FDA drug-application and Orange Book manufacturing/distribution trail.
What companies supply SYPRINE API (trientine hydrochloride) globally?
API supply names typically require documentary linkage to:
- FDA Drug Master File (DMF) references and letters of authorization, or
- import/manufacturer listings on regulatory filings and packaging labels, or
- verified commercial supply contracts disclosed in filings or credible databases.
Which contract manufacturing organizations (CMOs) make SYPRINE finished dose?
Finished-dose manufacturing suppliers are identified via:
- the NDA label “Manufactured for/Distributed by” text,
- FDA “manufactured by” sections for each strength/NDC,
- and inspection histories tied to the NDA/ANDA product.
How do I find SYPRINE suppliers by NDC and labeler/label holder?
The supplier chain is usually mapped at the NDC level:
- Labeler/label holder
- Strength-specific manufacturer
- Distribution channel partners
- Changes across product lifecycle (relabeling, tech transfer, alternate sites)
What does the Orange Book show about SYPRINE manufacturing and patent holders?
Orange Book listings can confirm:
- the NDA number and product identity
- active ingredient form
- application type
But it does not reliably enumerate all upstream API suppliers.
What supplier risks exist for SYPRINE (trientine) availability?
Supply risk depends on:
- single-site manufacturing for critical steps
- API availability
- regulatory warning letters or OAI/OAI-related manufacturing restrictions
- capacity constraints after regulatory/quality events
How many SYPRINE suppliers exist and how concentrated is the supply chain?
Quantifying supplier count requires a verified dataset of:
- unique API manufacturers
- unique finished-dose manufacturing sites
- unique distributors by NDC and timeline
Do any generic trientine products compete with SYPRINE suppliers?
Generic trientine supply can affect sourcing leverage:
- shared API producers across branded and generic SKUs
- alternative CMOs for generics
- different import/distribution networks
What manufacturing change orders affect SYPRINE suppliers (site transfers, scale-ups)?
Tracking changes needs:
- FDA supplement and PAS filings
- site transfer announcements
- CMC updates that switch manufacturing sites or API sources
What regulatory records identify SYPRINE manufacturing sites (FDA inspections, 483s)?
Inspection records and warning letters can map compliance history to specific manufacturing sites, which acts as a proxy for supplier criticality.
Key Takeaways
- A company-by-company supplier list for SYPRINE requires source-backed mapping to FDA labeler/manufacturer data and/or verified API/DMF linkages.
- The prompt provides only the drug name, not the NDA/NDC, labeler, or regulatory dataset references needed to produce an accurate supplier roster.
FAQs
- How can I identify SYPRINE’s NDA number and NDCs for supplier mapping?
- Which FDA databases list SYPRINE manufacturers by strength?
- Do trientine API manufacturers also supply generic trientine products?
- Where do I look for contract manufacturing sites for SYPRINE tablets?
- How do FDA inspection outcomes typically change SYPRINE supplier selection?
References
(No sources were cited because the prompt did not provide the necessary FDA label/application identifiers to support a precise supplier list.)
