Suppliers and packagers for ESLICARBAZEPINE ACETATE

ESLICARBAZEPINE ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211199	ANDA	Ascend Laboratories, LLC	67877-585-30	30 TABLET in 1 BOTTLE (67877-585-30)	2025-05-06
Alkem Labs Ltd	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211199	ANDA	Ascend Laboratories, LLC	67877-586-30	30 TABLET in 1 BOTTLE (67877-586-30)	2025-05-06
Alkem Labs Ltd	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211199	ANDA	Ascend Laboratories, LLC	67877-587-60	60 TABLET in 1 BOTTLE (67877-587-60)	2025-05-06
Alkem Labs Ltd	ESLICARBAZEPINE ACETATE	eslicarbazepine acetate	TABLET;ORAL	211199	ANDA	Ascend Laboratories, LLC	67877-588-30	30 TABLET in 1 BOTTLE (67877-588-30)	2025-05-06

ESLICARBAZEPINE ACETATE Suppliers: Market Supply Positions and Sourcing Paths

Last updated: April 25, 2026

Who supplies eslicarbazepine acetate API and key intermediates?

Eslicarbazepine acetate is supplied through (1) finished-dose manufacturers for branded or generic tablets and (2) API suppliers that produce eslicarbazepine acetate or drug-substance precursors used to manufacture it. On the API side, the supply chain typically includes chemical manufacturers of the eslicarbazepine core intermediate and esterification/acetylation steps that yield the acetate salt form used in tablets.

For sourcing and procurement, the most actionable supplier universe is the set of companies that (a) have a regulatory footprint for eslicarbazepine acetate tablets in major jurisdictions and (b) are active API or intermediate suppliers in the same chemical space (carboxamide-to-salt-form derivatization routes). The practical outcome is that procurement commonly lands with:

• API producers marketing “eslicarbazepine acetate” as a drug substance (DMF-supported or dossier-supported).
• Contract manufacturers producing tablets using sourced API.
• Intermediate suppliers that sell the upstream eslicarbazepine-related compound(s) used to form eslicarbazepine acetate.

Which companies are the highest-probability supplier targets for sourcing?

The supplier list below is constrained to entities that are publicly tied to eslicarbazepine acetate products or dossiers (directly or via regulated product supply). This gives the highest hit-rate for legitimate, traceable supply rather than speculative chemical distributors.

API and intermediate supply targets (regulatory-linked)

Supplier type	Supplier	Market role	What to request for qualification
API	Ascend Laboratories / Ascend?	API and/or dossier-backed drug substance supply in controlled small molecule categories	API CoA, DMF status, impurity profile, stereochemical/solvent residue compliance package
API	Hetero Labs (Hetero Drugs)	Generic active supply network for CNS small molecules	DMF/ASMF reference, batch consistency data, residual solvent report
API	Lupin	API plus finished-dose capability in branded/generic supply	Letter of Authorization pathways (if required), validation packet for tablet-formulation route
API	Zydus (cadila)	API and solid oral manufacturing ecosystem	API specs, genotoxic impurity strategy, stability data
API	Sun Pharmaceutical Industries	API and finished-dose manufacturing presence in multiple markets	API dossier linkage, regulatory history for eslicarbazepine acetate solids
API	Torrent Pharmaceuticals	Small-molecule CNS portfolio manufacturing presence	API specs and impurity reporting, regulatory status by region
Tablet maker	Dr. Reddy’s Laboratories	Finished-dose supply into multiple geographies	Tablet formulation specs, bioequivalence basis, GMP certificate for product site
Tablet maker	Teva	Finished-dose supplier presence for eslicarbazepine acetate products in generics	Finished product dossier references, CoA traceability
Tablet maker	Sandoz	Finished-dose generic supply	Batch release data, stability and packaging specs
Tablet maker	Cipla	Finished-dose generic supply network	GMP and product regulatory file summary
Tablet maker	Mylan/Viatris	Finished-dose generic supply network	Product dossier reference and batch consistency

Note: The supplier universe above is a procurement target list, not a guarantee that each entity currently supplies eslicarbazepine acetate API in every region.

Which finished-dose manufacturers define the bulk buying opportunities?

In procurement practice, tablet manufacturers buy API and place it into finished oral solids. Where API supply is constrained, finished-dose manufacturers are often the most reliable gateway into regulated supply, because they maintain GMP release and consistent batch records for the final product.

Finished-dose supply targets with established market presence

Company	Typical procurement pathway	What to ask operationally
Dr. Reddy’s Laboratories	Generic tablets sourcing	Tablet strength, packaging NDC/GTIN mapping, CoA format
Teva	Generic tablets supply	Distribution lanes by market, release specs
Sandoz	Generic tablets supply	Country approvals list, stability shelf-life commitments
Viatris (Mylan legacy)	Generic tablets supply	Quality agreement template, change control process
Cipla	Generic tablets supply	Batch release and regulatory file access format
Accord/Biocon ecosystem (where applicable)	EU/other market generics supply	DMF-to-product linkage policy and impurity specs

How to qualify API suppliers for eslicarbazepine acetate (spec and dossier checks)

For drug substance purchases, the qualification package usually hinges on:
1) DMF/ASMF position for eslicarbazepine acetate in the target regulatory region.
2) Impurity controls aligned with the impurity profile for the specific synthetic route used to form the acetate.
3) Residual solvents and genotoxic impurity strategy consistent with ICH guidance.

Minimum procurement diligence for eslicarbazepine acetate API commonly includes:

• Quality documents: CoA, GMP certificate, impurity specification sheet, residual solvent report, particle size (if relevant), and polymorph/solid state form controls where applicable.
• Stability: Accelerated and long-term stability results for API and relevant intermediate(s).
• Regulatory linkage: DMF/CEP/ASMF status in the importing authority for the company’s manufacturing site.
• Change control: notification timeline and variation submission responsibility.

Where suppliers cluster by chemistry route

Procurement roadmaps often align supplier clusters to the synthetic logic:

• Route A: upstream core intermediate → eslicarbazepine acetate formation (acetylation/esterification step control, then salt/solvate management).
• Route B: finished-dose tablet manufacturing that sources API from multiple qualified vendors and maintains a supply continuity plan.

In practice, buyers should route sourcing through suppliers that can document:

• Their specific intermediate chain to eslicarbazepine acetate.
• Their solvent system and acetylation conditions that drive impurity formation.
• Their site-level GMP record and regulatory file ownership or authorization.

What to prioritize when selecting an actual supplier

For high-reliability supply, prioritize suppliers that can deliver within a single compliance envelope:

• DMF-supported API supply in the target region.
• Stable impurity pattern across batches (not just meeting total impurity limits).
• Consistent particle size/solid state form controls for the intended formulation (unless the API grade and polymorph spec are locked).
• Demonstrated tablet manufacturing capability at scale if you are buying finished-dose or doing tech transfer.

Key Takeaways

• Eslicarbazepine acetate supply is dominated by regionally authorized finished-dose manufacturers and DMF/ASMF-supported API suppliers that can document impurity control, residual solvents, and stability.
• The most actionable supplier targets for business procurement typically come from companies with established eslicarbazepine acetate product presence in major markets (EU/UK/US).
• Supplier qualification for API should be routed through regulatory dossier linkage (DMF/ASMF), impurity profile consistency, stability data, and GMP site controls.

FAQs

1. Do tablet manufacturers supply eslicarbazepine acetate API indirectly?
   Yes. Many tablet makers buy API from qualified sources and can act as an entry point for reliable supply if you negotiate under a quality agreement and dossier-access terms.

2. Is DMF/ASMF required to buy eslicarbazepine acetate API for regulated markets?
   In practice, yes, because importing authorities and downstream filing depend on dossier linkage for approvals and variations.

3. What quality documentation should come with eslicarbazepine acetate API?
   CoA plus impurity profile, residual solvent report, stability package, GMP certificate, and change control commitments for the manufacturing site.

4. What is the biggest supplier selection risk for eslicarbazepine acetate?
   Batch-to-batch impurity drift driven by route/process differences that can complicate regulatory filing or formulation robustness.

5. How do I reduce supply disruption risk?
   Use at least two qualified vendors with confirmed dossier linkage in the target region and lock supply via a quality agreement and change-control SLA.

References

1. FDA. Drug Master Files (DMF) / Active Ingredient Development Documents. United States Food and Drug Administration.
2. EMA. European Medicines Agency: Regulatory requirements for manufacturing and quality documentation. European Medicines Agency.
3. ICH. Q3A(R2) Residual Solvents; Q3B(R2) Impurities in New Drug Substances; M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities. International Council for Harmonisation.