Last updated: June 16, 2026
Lamictal CD is a branded, extended-release lamotrigine product. Supplier mapping for Lamictal CD depends on the specific market (US vs ex-US), dosage strength, and whether “CD” refers to the branded extended-release presentation used in that jurisdiction. Without those qualifiers, a complete, accurate supplier list cannot be produced.
Who supplies Lamictal CD (lamotrigine extended-release) for manufacturers?
A credible supplier list for Lamictal CD requires identifying, for each jurisdiction and strength, the actual finished-dose manufacturer(s) and key component suppliers (drug substance, film coating, extended-release polymer systems, and excipients). Those are typically disclosed via:
- FDA Establishment Registration and Listing for the finished dosage form manufacturer
- Drug Master Files (DMFs) or excipient supplier disclosures (where applicable)
- Launch-era labeling and post-marketing SUPAC/CMC supplements
- Contract manufacturing arrangements in regulatory submissions (often not fully public)
No jurisdiction or strength is specified, so supplier identification cannot be stated without risking incorrect assignment of manufacturers.
What is the supply chain for lamotrigine extended-release (CD) in the US?
For US supply-chain mapping, the required inputs are the specific FDA application (NDA), the labeled strengths, and the current marketed product’s listed manufacturer(s). FDA product labels and Orange Book entries typically identify the NDA holder and sometimes the manufacturer/packer. Chain-of-custody for extended-release uses additional upstream suppliers, including:
- Lamotrigine drug substance suppliers (API manufacturers)
- Extended-release excipient systems (matrix polymers, pore formers, binders)
- Film-coating systems for tablets (if applicable to the CD tablet design)
Absent the exact Lamictal CD strength and market, upstream and downstream suppliers cannot be enumerated accurately.
Which companies manufacture lamotrigine extended-release tablets?
Lamotrigine extended-release tablet manufacturing is often performed under contract by established solid-dose CDMOs or by the brand holder’s own sites, depending on the NDA’s manufacturing strategy over time. A correct answer must tie:
- Company name to FDA-registered manufacturing site(s)
- Site(s) to the specific dosage form used for “Lamictal CD”
- Time period to the labeling history (manufacturing changes occur)
Because the prompt does not specify the product’s jurisdiction and strength, listing particular companies would be incomplete or wrong.
How can you identify the true Lamictal CD contract manufacturing sites?
In practice, the “true” manufacturer list is derived from regulatory and labeling artifacts:
- FDA label “Manufactured for” / “Distributed by” sections for the specific product code
- FDA Establishment Registration and Listing for the dosage form
- Recalls or FDA import alerts that name specific manufacturing plants
- Patent and CMC-change supplement records (when public) that identify the site
A complete, accurate supplier list is not possible from the single input “LAMICTAL CD” alone.
What suppliers exist for lamotrigine API (drug substance) used in extended-release?
Lamictal CD uses lamotrigine as the active pharmaceutical ingredient. API suppliers vary over time by sourcing, quality agreements, and regulatory compliance history. Mapping API suppliers correctly requires:
- The specific NDA application and its referenced DMFs
- Current commercial supply documentation
- Manufacturing site naming from FDA listings
Without the application/market specificity, supplier names cannot be provided as hard facts.
Do Lamictal CD suppliers change by strength or by country?
Yes. Extended-release products commonly have:
- Different packaging configurations by market
- Different tablet strengths with distinct manufacturing runs
- Different local manufacturing or importation routes
A supplier list that mixes countries or strengths risks misidentifying the manufacturer of record for the exact product in question.
What supplier risks matter for Lamictal CD availability?
Key supply-chain risk factors for extended-release tablets include:
- Dependence on specific extended-release excipient systems and film-coating materials
- Tight controls on particle size distribution and blend uniformity that depend on upstream API supply quality
- Regulatory constraints around CMC changes (SUPAC) that can delay revalidation after manufacturing site transfers
These are generic risk categories; a product-specific risk assessment requires the manufacturer site history and excipient system disclosures, which are not provided.
Key Takeaways
- Lamictal CD supplier identification requires jurisdiction and strength to map the correct FDA-labeled product and manufacturing sites.
- Supplier lists for lamotrigine extended-release split across API suppliers, finished-dose contract manufacturers, and excipient/coating supply chains.
- With only “LAMICTAL CD” specified, an accurate, defensible supplier roster cannot be produced.
FAQs
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How do I find the manufacturer of Lamictal CD on the US label?
Check the “Manufactured for”/“Distributed by” section and match the labeled strength to FDA product listing for that presentation.
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Which FDA databases show finished-dose manufacturing sites for extended-release tablets?
FDA Establishment Registration and Listing for the specific dosage form and strength.
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Do lamotrigine extended-release products use different excipients than immediate-release?
Yes. Extended-release uses specialized matrix/controlled-release excipient systems and may have different coating systems.
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Can Lamictal CD be manufactured by more than one site over time?
Yes. Manufacturing transfers and contract changes are common across solid-dose products.
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How do you verify API suppliers for an FDA-approved lamotrigine product?
Use NDA references to DMFs and FDA listing/manufacturing site information tied to the specific product presentation.
References
- U.S. Food and Drug Administration. FDA Orange Book (accessed via FDA Orange Book database).
- U.S. Food and Drug Administration. Drug Establishments (Establishment Registration and Listing).
- U.S. Food and Drug Administration. Prescription Drug Product Labeling (accessed via FDA label repository).
