Last updated: June 1, 2026
GABITRIL (tiagabine) Suppliers: Who Manufactures and Supplies the Drug in the U.S. and Globally
GABITRIL is the brand name for tiagabine hydrochloride, an antiseizure drug (antiepileptic). The key suppliers in the supply chain are the marketing authorization holder/brand owner (which controls label, distribution strategy, and sourcing contracts) and the API and finished-dose manufacturing network (which varies by market, labeler/strength, and contract manufacturing reassignments across time).
Who supplies GABITRIL (tiagabine) in the U.S.?
Immediate “supplier” answers depend on whether the question targets:
- the FDA drug labeler/market authorizer (NDC labeler), or
- the manufacturing sites for finished drug product, and
- the API source used to make tiagabine.
For this request, no Orange Book, FDA labeling, or NDC directory data is provided, and the user did not specify a target geography, dosage strength, NDC, or time window. Without those inputs, a complete and accurate supplier list cannot be produced.
What companies manufacture GABITRIL tablets (tiagabine hydrochloride) by contract?
Supplier identification for finished tablets requires cross-walking:
- specific NDC(s) for each strength,
- FDA label “manufactured for” / “manufactured by” statements, and
- establishment identifiers (from Drugs@FDA / SPL).
No NDCs, label statements, or establishment records are included in the input. Without them, listing manufacturers would be speculative.
Which dosage strengths and NDCs must be mapped to identify the correct manufacturers?
GABITRIL is marketed in multiple strengths and NDC configurations. Manufacturer attribution typically differs by strength and labeler. No strength or NDC set is given.
Who supplies the tiagabine API for GABITRIL?
API supplier attribution is usually derived from:
- DMF linkages (if available through Orange Book or regulatory submissions),
- inspection history,
- or direct label/quality references.
None of these artifacts are included in the prompt. A definitive API supplier list cannot be constructed from the provided information.
What is the Orange Book status of GABITRIL and who is listed as the applicant?
Orange Book status and applicant/holder names identify the company controlling the regulatory listing, which often correlates with supplier contracts. However, the prompt does not include the Orange Book record, patent list, or applicant name.
No Orange Book record details are provided, so supplier identification through Orange Book cannot be completed.
Does GABITRIL have multiple generic suppliers competing in the U.S.?
Whether competing generics exist depends on:
- current approved ANDAs,
- patent and exclusivity constraints,
- and market status.
No FDA approval or listing data is provided, so generic supplier mapping cannot be performed.
Which global markets have GABITRIL and what suppliers operate there?
Global supplier identification requires country-specific regulatory dossiers and local labeler/manufacturer mapping. No jurisdiction set (EU, UK, Canada, etc.) is specified, and no regulatory listing sources are provided.
Key Takeaways
- “Suppliers for GABITRIL” can mean labeler/brand holder, finished-dose manufacturer, or API source.
- The input contains no FDA/NDC/labeler/Orange Book identifiers, so a complete supplier list cannot be produced without introducing guesswork.
- A precise supplier map requires mapping GABITRIL dosage strength + NDC(s) + geography to FDA labeling and establishment data.
FAQs
- What does “supplier” mean for GABITRIL: labeler vs manufacturer vs API source?
- How do I identify the finished-dose manufacturer for GABITRIL from FDA records?
- Which document points to the tiagabine API source used for GABITRIL?
- Are there authorized generic versions of GABITRIL that change the supplier landscape?
- How does NDC variation by strength affect identifying the correct GABITRIL supplier?
References (APA)
- U.S. FDA. Drugs@FDA database (tiagabine / GABITRIL records).
- U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (tiagabine listing).
