Suppliers and packagers for generic pharmaceutical drug: FELBAMATE

FELBAMATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	FELBAMATE	felbamate	SUSPENSION;ORAL	202385	ANDA	Amneal Pharmaceuticals LLC	65162-686-88	237 mL in 1 BOTTLE (65162-686-88)	2011-12-16
Amneal Pharms	FELBAMATE	felbamate	SUSPENSION;ORAL	202385	ANDA	Amneal Pharmaceuticals LLC	65162-686-90	473 mL in 1 BOTTLE (65162-686-90)	2011-12-16
Novitium Pharma	FELBAMATE	felbamate	SUSPENSION;ORAL	211333	ANDA	Novitium Pharma LLC	70954-051-10	237 mL in 1 BOTTLE (70954-051-10)	2022-07-15
Novitium Pharma	FELBAMATE	felbamate	SUSPENSION;ORAL	211333	ANDA	Novitium Pharma LLC	70954-051-20	473 mL in 1 BOTTLE (70954-051-20)	2022-07-15

Suppliers and packagers for generic pharmaceutical drug: FELBAMATE

Last updated: May 26, 2026

FELBAMATE Suppliers: Contract Manufacturers, API Sources, and Key Market Players

Felbamate supplier coverage is fragmented. The practical sourcing universe for felbamate splits into (1) API suppliers, (2) finished-dose manufacturers for US-marketed product, and (3) downstream contract manufacturers that can build tablets/suspensions under cGMP. The most reliable path for supply planning is to anchor on the current US reference product’s labeled manufacturer(s) and then map upstream API and toll manufacturing through known cGMP networks and drug substance intermediates used to produce felbamate.

Who makes felbamate API (drug substance) and who are the felbamate suppliers?

Featured snippet answer: Felbamate is typically supplied through a small set of specialty chemical/API producers and ingredient networks tied to antiepileptic portfolios. For sourcing and compliance, the supplier set is best derived from cGMP drug substance supply chains that support commercial finished-dose builds and from listings tied to marketed dosage forms.

Common categories of felbamate suppliers

• API manufacturers (drug substance): produce felbamate bulk drug, including batch release under GMP.
• Finished-dose manufacturers: make tablets and any marketed oral dosage forms using purchased or internally produced felbamate.
• Contract development and manufacturing organizations (CDMOs): build under toll manufacture or development-to-scale agreements.

Supplier due-diligence targets

• GMP status for drug substance (DMF and/or CEP alignment)
• Experience with high-sensitivity antiepileptic raw materials and controlled batch documentation
• QC package readiness (assay, impurity profile, residual solvents, water content)
• Scale capability (kg-to-multi-ton range is uncommon for niche antiepileptics)

Which companies supply felbamate tablets or finished dosage forms in the US?

Featured snippet answer: Finished-dose felbamate supply in the US is linked to the company that holds/markets the labeled product and any authorized contract manufacturer(s) named on labeling and regulatory submissions.

How to identify finished-dose felbamate suppliers

• Use the US product label “Manufactured for/Manufactured by” sections to identify the current manufacturer and packager.
• Cross-walk manufacturer names to FDA submissions and manufacturing site disclosures.
• Map those names to CDMO capabilities if manufacturing is outsourced.

What is the best way to source felbamate for development or commercial supply?

Featured snippet answer: The most operational approach is dual-rail sourcing: lock one finished-dose manufacturing partner for packaging and scale risk control, while sourcing felbamate API through a second rail that provides a compliant DMF or equivalent regulatory support.

Sourcing playbook

1. Regulatory anchor: confirm whether the supplier can support an approved drug master file (DMF) or equivalent dossier package used for ANDA/505(b)(2) referencing.
2. Quality system fit: ensure supplier has cGMP documentation and analytical method robustness for felbamate and impurity specifications.
3. Supply continuity: qualify at least two potential supply routes (primary and backup) for API and for solid oral manufacturing.
4. Stability and packaging compatibility: align supplier batch release specs with intended formulation and shelf-life claims.

Do DMFs exist for felbamate, and which suppliers file them?

Featured snippet answer: DMF availability is supplier-specific. Felbamate’s market size and niche status often concentrate API filings to a limited number of specialized firms that can support regulatory referencing.

DMF diligence checkpoints

• DMF type (drug substance vs. drug product)
• Holder/agent identity and manufacturing site
• Latest amendment dates and whether the site is still active
• Impurity control strategy alignment with target compendial or internal specifications

How do felbamate suppliers compare by cGMP and regulatory readiness?

Featured snippet answer: Supplier differentiation is mostly determined by regulatory artifacts (DMF/CEP), site GMP standing, impurity control capability, and ability to provide audit-ready documentation.

Comparison matrix for evaluating felbamate suppliers

Supplier type	Typical strength	Common gap in niches like felbamate
API cGMP manufacturer	Regulatory-ready drug substance, batch release testing	Limited capacity expansions
Finished-dose CDMO	Faster formulation-to-scale execution and packaging	Higher cost per unit for short runs
Toll manufacturing network	Lower overhead for supplier qualification	Less transparency on impurity methods
Specialty chemical intermediates	Lower cost API precursor supply	Need confirm full felbamate step cGMP and impurity controls

What contract manufacturers can toll-make felbamate tablets or suspensions?

Featured snippet answer: Toll manufacturing is usually delivered by CDMOs with strong oral solid manufacturing lines and documentation support for antiepileptic products. The practical selection is based on confirmed capability for controlled impurity profiles and stability requirements for felbamate.

Manufacturing capability checklist

• Solid oral dose lines (tablet compression) with validated segregation controls
• QA release method transfer capability (if referencing internal supplier methods)
• Compatibility with felbamate’s stability and moisture sensitivity profile
• Packaging line readiness (bottle/blister), labeling and serialization if required

Which regulatory pathways depend most on felbamate supplier quality?

Featured snippet answer: FDA pathway choices influence the level of supplier dossier integration required.

Pathway impact

• 505(b)(2): higher reliance on supplier data bridging and stability comparability.
• ANDA (generic): typically depends on drug substance control strategy, impurity profile, and DMF referencing.
• Clinical supply for new formulations: relies on supplier consistency across scale-up and method transfer.

When do supply risks rise for felbamate and how do suppliers mitigate them?

Featured snippet answer: Supply risk increases with consolidation of API filings, small market demand, and single-site manufacturing concentration. Mitigation is through dual sourcing and qualification of backup cGMP sites early.

Supply risk drivers in niche antiepileptics

• Small commercial base reduces incentive to expand capacity
• Regulatory updates can force site transfers or revalidation cycles
• Ingredient-specific impurity limits can become binding constraints

Key Takeaways

• Felbamate supply chains are niche and concentrated; sourcing success depends on regulatory-ready API support and cGMP finished-dose execution.
• The most actionable supplier mapping uses the labeled product’s named manufacturer(s), then tracks upstream API through DMF-holder networks.
• Mitigate supply continuity risk with dual-rail sourcing: one API source and one finished-dose partner, plus a qualified backup rail.
• Supplier evaluation should prioritize DMF/CEP support, impurity control capability, audit readiness, and method transfer performance.

FAQs

1. How do I find the current felbamate manufacturer for the marketed US product?
   Use the “Manufactured for/Manufactured by” sections on the latest FDA label and then map those sites to FDA submission manufacturing disclosures.

2. Can felbamate be sourced through a toll manufacturing model for tablet production?
   Yes, through oral solid CDMOs, but selection must be tied to impurity control, stability support, and packaging validation for the target dose form.

3. What should be verified in a felbamate API quality agreement?
   Impurity profile alignment, batch release methods, residuals/solvents controls, stability and retest specifications, and change control transparency.

4. What supplier documentation is most important for ANDA development of felbamate?
   Drug substance characterization, DMF referencing compatibility, method transfer readiness, and stability data that supports comparability for the proposed formulation.

5. How can felbamate supply be de-risked for commercial launch timelines?
   Qualify a backup API and an alternate finished-dose site early, lock audit schedules, and ensure method and spec consistency across initial and replacement batches.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. FDA Drug Master File (DMF) information and guidance. US Food and Drug Administration.