Last updated: June 3, 2026
Lamictal ODT (lamotrigine) suppliers: who manufactures, licenses, and supplies the US market
Lamictal ODT (lamotrigine orally disintegrating tablets) is supplied in the US market through a multi-tier chain that includes the branded product holder and generic-component/toll-manufacturing suppliers. This answer is limited to the supplier-identification data available from public FDA labeling records; it does not enumerate every subcomponent supplier (API excipients, blistering, printing, ODT compression, or packaging) because those upstream parties are not consistently disclosed in FDA-facing documents.
Who supplies Lamictal ODT in the US?
Branded supplier on US labeling:
- GSK (GlaxoSmithKline) / ViiV is listed as the marketing authorization/brand holder on US product labeling for Lamictal products, including Lamictal ODT.
Manufacturing sites (label-disclosed):
FDA labeling for Lamictal ODT includes one or more listed manufacturers and/or packaging/manufacturing facilities. Those facilities are the legally responsible supply chain entities for commercial batches.
Which manufacturers make Lamictal ODT tablets (site-level)
Lamictal ODT labeling identifies specific manufacturing operations. Typical label-disclosed roles include:
- Manufacturing the tablet drug product
- Packaging (bottles/blister where applicable)
- Batch release/distribution
A complete site list requires matching the exact strength and NDC to the label currently on file in the FDA Drugs@FDA database. The label text and its “Manufactured for” / “Manufactured by” fields vary by strength and by NDC packaging configuration.
How do you map Lamictal ODT NDCs to suppliers?
To identify the exact supplier for a given unit (strength and package), the practical method is:
- Pull the NDC for the specific Lamictal ODT strength and package size
- Retrieve the corresponding FDA label (Drugs@FDA “Label” documents)
- Read the label fields that specify manufactured for by whom and manufacturing location(s)
This yields the definitive label-disclosed supplier per NDC.
What about lamotrigine API suppliers for Lamictal ODT
API sourcing is not reliably disclosed in FDA labeling for the branded product beyond:
- The presence of lamotrigine as the active ingredient
- Label language about manufacturing and quality
Upstream API suppliers (contract API producers) are often disclosed only in confidential submissions or via non-FDA sources (DMFs, vendor certifications, procurement data). Those are not consistently public at a supplier-name level for Lamictal ODT.
What excipient and ODT-specific formulation suppliers exist for Lamictal ODT?
OTD dosage forms depend on:
- Disintegrant selection
- Binders and tablet matrix excipients
- Moisture control and stability excipients
- ODT manufacturing process (compression and disintegration property control)
Excipients are typically listed on the label, but the specific vendor brands for each excipient are generally not disclosed for Lamictal ODT in FDA-facing labeling.
Does Lamictal ODT use toll manufacturing or multiple sites?
Branded oral solid drugs commonly use multi-site strategies, but whether that applies to Lamictal ODT depends on:
- Label revisions across time
- NDC-specific manufacturing assignments
- Packaging configuration changes
Only the current label-matched manufacturer statements can be treated as accurate supplier facts for a given NDC.
Supplier landscape summary (actionable)
- Brand-level commercial supplier (US): GSK/ViiV as brand holder and marketing entity.
- Drug-product manufacturing and packaging: label-disclosed manufacturers tied to specific Lamictal ODT strength and NDC.
- API and excipient suppliers: not consistently disclosed at vendor-name level in public FDA labels; excipient ingredients are listed, but upstream supplier identities are not.
Key Takeaways
- The only reliably disclosed “supplier” facts from public records for Lamictal ODT are the label-identified manufacturer(s)/packager(s) tied to specific strengths and NDCs, plus the brand holder.
- API and excipient vendor names are not consistently public in FDA labeling for Lamictal ODT, limiting upstream supplier enumeration.
- Supplier mapping should be done via NDC-to-label lookup to ensure site-accurate identification.
FAQs
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How do I find the manufacturer of Lamictal ODT for a specific strength and NDC?
Use the NDC on the bottle to pull the matching FDA label (Drugs@FDA) and read the “manufactured for/manufactured by” fields.
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Are Lamictal ODT manufacturers different across strengths?
Yes, label language can vary by strength and packaging configuration, so each NDC must be checked.
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Who is the brand holder for Lamictal ODT in the US?
The brand holder listed on US labeling is associated with GSK/ViiV.
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Are lamotrigine API suppliers listed for Lamictal ODT?
Vendor-level API supplier identities usually are not disclosed in public labeling.
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Do excipients for Lamictal ODT indicate the supplier companies?
Excipient identities are listed, but excipient vendor brand names are generally not disclosed.
References
- FDA. Drugs@FDA: Lamictal (lamotrigine) and Lamictal ODT label documents (accessed via FDA Drugs@FDA label pages).
