Last updated: May 23, 2026
GRALISE suppliers: who manufactures gabapentin enacarbil tablets (Gusst 600 mg) and what to verify in the supply chain
GRALISE (gabapentin enacarbil) is an extended-release prodrug of gabapentin. The supply chain centers on (1) contract manufacturing of the finished tablets, (2) upstream manufacture of gabapentin enacarbil API, (3) excipient and coating systems for extended-release drug product, and (4) packaging/labeling for US distribution.
Note: No verifiable, complete supplier list (API makers + finished-dose manufacturers + packaging partners) can be produced from the information provided in the prompt.
Which companies supply the API and finished tablets for GRALISE (gabapentin enacarbil) in the US?
No complete and reliable supplier set can be listed without citing specific manufacturers tied to GRALISE’s commercial product (US label/packager + Orange Book listed facilities and/or FDA Drug Master File references). Without those anchored references, any named “suppliers” would be speculative.
What should be checked to identify GRALISE manufacturing suppliers
For US GRALISE, supplier identification is typically validated through:
- Orange Book listing of drug product and patents tied to the marketed dosage forms
- FDA label and NDC/labeler and manufacturer of record
- Drug Master File (DMF) references for API and critical excipients
- cGMP inspection histories for the actual manufacturing facilities tied to labeled product
- NDC labeler/packager data on the unit distributed in the US
What contract manufacturers make GRALISE 600 mg extended-release tablets?
A defensible answer requires the maker of record for the GRALISE dosage form(s) that correspond to the US NDC(s) currently marketed, plus any disclosed contract manufacturing relationships. The prompt provides no NDCs or label manufacturers, so no factual manufacturer attribution can be compiled.
Key drug product components that drive supplier qualification
- Extended-release matrix composition (tablet formulation system)
- Coating process controls (if used for diffusion/erosion profile)
- Granulation, compression, and dissolution testing
- Stability programs for long release specs
Who supplies gabapentin enacarbil API for GRALISE?
Gabapentin enacarbil API sourcing cannot be listed without:
- confirmed API manufacturer(s) from DMF references, and/or
- verified API supplier disclosures in regulatory filings tied to marketed tablets.
How API suppliers are typically evidenced
- DMF holder/manufacturer names cross-referenced to the approved application
- Revisions in DMF status aligned with label changes
- Public procurement or quality agreements only when tied to the labeled product
What excipient and coating suppliers are used in GRALISE tablets?
Excipient supplier chains are generally not public at the level required for a named list. Without GRALISE’s approved formulation disclosures (or DMF/excipient references), supplying named excipient vendors would not be evidence-based.
Where excipient suppliers show up
- DMFs for excipients (rare but possible)
- Vendor qualification statements in filings
- Facility inspection documentation tied to manufacturing site
Where can GRALISE suppliers be verified: Orange Book, FDA label, and DMF references?
A supplier list is verifiable only by triangulating:
- Orange Book product listing (drug product identity, application holder, and sometimes manufacturing info)
- DailyMed/label (manufacturer of record, packager)
- DMF references (API and some excipients)
No citations or listings are included in the prompt, so this triangulation cannot be executed here.
What risks exist if GRALISE suppliers change (API shortages, site transfers, or scale-up)?
A risk analysis also needs a supplier baseline (which facilities make the product and where the API is produced). Without that baseline, the supplier-change risk can’t be tied to GRALISE specifically.
Standard supply risks for extended-release products
- Spec drift during process changes (granulation/compression)
- Dissolution profile sensitivity
- Tight impurity control for enacarbil intermediates
- Regulatory friction during site transfers (comparability studies)
Key Takeaways
- GRALISE supplier identification requires evidence from FDA label manufacturing/packaging info, Orange Book and/or DMF-linked facility references, and NDC labeler data.
- The prompt does not provide those anchor data points, so a factual supplier list cannot be produced.
FAQs
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How do I confirm the manufacturer of record for GRALISE in the US?
Use the current GRALISE prescribing information/DailyMed label and NDC labeler/manufacturer of record entries.
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Does Orange Book list GRALISE manufacturing sites and contract manufacturers?
Orange Book primarily ties to listed patents and product/application info; manufacturing-site detail can be incomplete and must be cross-checked with label/DMF.
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How can I identify the gabapentin enacarbil API DMF holder for GRALISE?
Use the FDA application-linked DMF references and DMF holder records aligned to the approved application for the marketed product.
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What supply-chain bottlenecks typically affect extended-release gabapentin enacarbil tablets?
Process consistency risks (granulation/compression), dissolution profile control, and API impurity limits.
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What evidence supports naming excipient suppliers used in GRALISE?
Only DMF-based references or confirmed formulation disclosures linked to regulatory submissions should be used.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- DailyMed. GRALISE (gabapentin enacarbil) label information.
