Share This Page
Suppliers and packagers for LAMICTAL XR
✉ Email this page to a colleague
LAMICTAL XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | NDA | GlaxoSmithKline LLC | 0173-0754-00 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0754-00) | 2009-07-06 |
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | NDA | GlaxoSmithKline LLC | 0173-0755-00 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0755-00) | 2009-07-06 |
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | NDA | GlaxoSmithKline LLC | 0173-0756-00 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0756-00) | 2009-07-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for LAMICTAL XR
LAMICTAL XR suppliers: API, contract manufacturers, and key packaging sources
Lamictal XR (lamotrigine extended-release) is commercially supplied through a vertically integrated development-and-manufacturing model centered on GSK and its manufacturing network, with additional reliance on specialty chemical/API operations and contract packaging for branded dosage distribution in the U.S. This supplier footprint matters for supply risk, generic entry timing, and formulation replication because Lamictal XR is an extended-release matrix product where both API quality and release-control manufacturing controls drive regulatory and patent defensibility.
Who supplies the active ingredient for Lamictal XR (lamotrigine extended-release)?
API source model for lamotrigine ER
Lamotrigine API supply is typically sourced from established small-molecule chemical manufacturers that support branded neurology brands with multi-site supply capability. For Lamictal XR, the core supply chain is built around:
- Lamotrigine API production at qualified chemical sites supplying GSK manufacturing
- Incoming material testing and release under GSK quality systems
- Transfer into finished-dosage manufacturing for extended-release tablets/capsule-type dosage form
Supplier identification limits
A complete, defensible supplier list at the site level (named API plants) requires explicit evidence from dossier-level manufacturing assignments or labeled inspections tied to Lamictal XR’s NDA/ANDA manufacturing sections. Without those site-specific assignments, any “named supplier” list risks being inaccurate.
Which companies manufacture Lamictal XR extended-release tablets?
Finished-dose manufacturing framework
Lamictal XR’s finished-dose manufacturing is performed through GSK manufacturing sites and/or qualified contract manufacturing partners under GSK product-specific controls. For extended-release solid oral dosage forms, the contract scope (if used) usually covers:
- Tablet pressing and/or granulation steps that preserve dissolution profile
- Film coating or tablet finishing steps
- In-process controls aligned to the approved release specification
- Validation of scale-up/tech transfer using the same critical quality attributes
Supply chain reality for ER oral solids
For ER products, generic substitution and “formulation workarounds” are constrained by:
- Dissolution and drug-release kinetics targets
- Content uniformity and particle size control of lamotrigine
- Lubrication, compression force, and binder systems
- Packaging controls for moisture/temperature stability
These constraints push branded supply chains toward established tablet manufacturing capability and robust qualification rather than high-turnover commodity tolling.
What contract packaging suppliers are used for Lamictal XR?
Common packaging roles
Lamictal XR product distribution in the U.S. typically uses packaging contractors for one or more of the following:
- Bottle or unit-dose pack assembly
- Labeling and serialization where applicable
- Case packing, palletizing, and warehouse-ready configuration
Why packaging suppliers matter
Packaging suppliers become a practical constraint for supply continuity because they may be the last-mile bottlenecks if:
- Bottle/cap component sourcing tightens
- Label stock and regulatory labeling formats change
- Serialization/track-and-trace rules expand
- Stability program packaging configurations require batch-level controls
A named list again depends on the labeling and manufacturing section disclosures tied to the specific NDA strength and dosage form.
How can you map Lamictal XR suppliers using FDA registrations and labeling?
Regulatory documents used in supplier mapping
A reliable supplier map for Lamictal XR typically comes from:
- FDA product labeling manufacturing statements (where the sponsor and responsible parties are named)
- NDA manufacturing site listings in FDA submission summaries or Structured Product Labeling sections
- Drug Establishment Registration (DER) records tied to labeler/manufacturer names
- Inspection histories that link a site to the NDA manufacturing category (API vs finished dose)
What to look for
When building a supplier register, extract these fields:
- NDA holder/labeler name
- Manufacturer of record for finished dose
- Manufacturer(s) of API or intermediate (as listed in labeling or CMC)
- Packaging labeler or packager of record
- Specific site addresses if listed in the relevant section
Without extracting these directly from the FDA-linked records for the exact Lamictal XR strengths/dosage form, it is not possible to produce an accurate supplier name list.
What supplier relationships exist for Lamictal XR in the U.S. market?
Dominant pattern: branded sponsor plus qualified manufacturing network
Lamictal XR’s supplier pattern is consistent with major branded neurology products:
- Sponsor-owned quality system and regulatory ownership through the NDA
- Manufacturing executed at sponsor sites and/or vetted CMO plants
- Contract packaging for distribution scale
Why U.S. supply depends on manufacturing slots
In ER oral solids, the critical path is often:
- Granulation-to-compression line capability
- Drying/humidity control steps
- Dissolution-validated batch release
- Stability and packaging configuration approvals
That makes supplier mapping commercially relevant for allocation planning during tight supply cycles.
How does supplier mapping affect generic and biosimilar entry risk for Lamictal XR?
Small-molecule ER risk is formulation and process
Lamictal XR is a small molecule; “biosimilar” framing does not apply. Generic risk for ER lamotrigine hinges on:
- Ability to achieve the same dissolution profile under bioequivalence requirements
- Manufacturing process control and excipient system replication
- Patent challenges on method-of-use, composition, or manufacturing/process claims
Supplier dependency is real
If a generic manufacturer cannot source a comparable lamotrigine material profile, or cannot reproduce ER release characteristics, the product faces:
- Higher formulation development iterations
- Bioequivalence study delays
- Regulatory risk in dissolution alignment
Supplier mapping therefore impacts not only current supply but also the feasibility of generic process equivalence.
Where are the most likely bottlenecks in Lamictal XR supply chain?
Highest-risk stages
For extended-release tablets, bottlenecks frequently occur in:
- API incoming quality consistency
- Solids handling equipment capacity and compression scheduling
- Moisture-sensitive manufacturing controls
- Packaging component lead times (bottle systems, labels)
Business implication
When supply tightness emerges, the constraint is usually plant scheduling or packaging component availability rather than API chemistry alone, given the need for ER process validation.
Key Takeaways
- Lamictal XR’s supply chain is centered on the brand sponsor (GSK) with qualified manufacturing and packaging partners supporting extended-release tablet production.
- Supplier mapping at the named-site level requires NDA/labeling-derived manufacturing and packaging records.
- For ER products, the commercially decisive factors are API quality consistency, ER release-control manufacturing controls, and packaging configuration reliability.
- Generic entry feasibility depends on formulation and process reproducibility, which links directly back to supplier input characteristics and manufacturing capability.
FAQs
- How do you verify the manufacturer of record for Lamictal XR on FDA labeling?
- Which manufacturing steps most affect extended-release lamotrigine dissolution profile?
- What packaging configuration changes can require stability re-evaluation for Lamictal XR?
- What evidence best supports identifying API versus finished-dose manufacturing sites for Lamictal XR?
- How does supplier continuity affect allocation risk for ER neurology brands like Lamictal XR?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drug Establishment Registration and Product Listing. FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishment-registration-and-drug-product-listing
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Lamictal XR (lamotrigine). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
More… ↓
