ARTEMETHER; LUMEFANTRINE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	COARTEM	artemether; lumefantrine	TABLET;ORAL	022268	NDA	Novartis Pharmaceuticals Corporation	0078-0568-45	24 TABLET in 1 BOTTLE (0078-0568-45)	2009-04-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Executive summary: Artemether-lumefantrine (AL; ACT) is sourced through a two-tier supply chain: (1) artemisinin-derived APIs (artemether and lumefantrine, plus upstream intermediates) and (2) finished-dose manufacturers producing tablets or dispersible formulations under NDA/ANDA/contract manufacturing arrangements. Commercial availability is concentrated among a limited set of global finished-dose suppliers and a smaller number of API and intermediate producers, with regional qualification pathways often determining which vendors can supply public-sector tenders, wholesalers, or hospital formularies.

Who supplies artemether-lumefantrine (AL) tablets and fixed-dose ACT products?

Finished-dose supply for AL is dominated by global generic and branded-market manufacturers that package fixed-dose combinations (typically 20 mg artemether/120 mg lumefantrine per tablet for standard adult regimens, with pediatric-strength variants). In practice, “supplier” splits into: finished-dose manufacturers (FDF) selling branded/generic products, and contract manufacturers producing for distributors or tender programs.

What companies manufacture finished-dose artemether-lumefantrine?

AL finished-dose suppliers are typically disclosed via:

FDA/US marketing authorization and labelholders (where applicable to local approvals)
WHO Prequalification (PQP) and related public procurement listings for LMIC markets
National regulatory registries and tender award documents for endemic countries
Wholesale/distributor catalogs for commercial channels

Practical point for supply planning: For AL, qualification barriers are usually less about formulation novelty and more about compliance with regulatory specs (dissolution, polymorph control, stability), source traceability of lumefantrine and artemether intermediates, and ability to scale under procurement schedules.

What dosage forms are typically supplied?

Film-coated tablets
Dispersible tablets or pediatric dispersible formulations (market-dependent)
Fixed-dose blister packs (common for program supply)

Which suppliers provide the artemether active pharmaceutical ingredient (API)?

Artemether is derived from artemisinin (or artemisinin-related starting materials) via established synthetic routes. API supply is concentrated among firms with:

Artemisinin derivative chemistry capability
Compliance documentation for API quality (GMP, DMF/CEP where used)
Ability to produce consistent assay and impurity profiles

What upstream intermediates affect artemether supply?

Downstream artemether manufacturing quality depends on upstream control of artemisinin feedstock quality and intermediates used to reach artemether:

Artemisinin-derived intermediates
Esterification and recrystallization steps governing polymorph and impurity control

Who are typical artemether API suppliers?

In AL supply chains, artemether API vendors are usually multi-product API suppliers or artemisinin-derivative specialists. These suppliers appear across multiple ACT combinations (artesunate derivatives also rely on similar upstream artemisinin supply networks).

Which suppliers provide lumefantrine API and how is it sourced?

Lumefantrine is more structurally complex than artemether and has a distinct API supply base. Lumefantrine API availability hinges on:

Synthetic capacity for lumefantrine core formation
Control of E/Z ratios (if applicable to process intermediates)
Tight impurity specification capability due to regulatory limits

What manufacturing steps constrain lumefantrine supply?

Key coupling and crystallization steps that impact impurity and particle-size distributions
Solvent and polymorph control during final isolation
Batch-to-batch reproducibility for formulation performance (bioavailability linkage)

How do lumefantrine supply bottlenecks show up commercially?

When supply tightens, it typically affects:

Finished-dose scheduling for tablets
Procurement lead times for tender programs
Costs for API and contract packaging

What contracts and sourcing models are used for AL procurement (API-to-FDF vs FDF-only)?

Suppliers operate under two common business models:

API-to-FDF integration

API is sourced and then formulation is manufactured internally or via CMOs with shared quality systems
Better control of traceability and impurity profile

FDF-only sourcing

Finished product is bought from a qualified manufacturer
Used by wholesalers, distributors, or public-sector procurement agencies lacking formulation manufacturing capacity

What is the most common sourcing route for public-sector AL supply?

In many jurisdictions, public procurement prefers prequalified or locally registered finished-dose products, pulling through verified supplier networks rather than awarding procurement directly to API producers.

Which suppliers are used in WHO tender supply chains for artemether-lumefantrine?

WHO procurement pathways commonly rely on:

WHO Prequalification (PQP) status for FDF
Listed manufacturing sites and tested quality performance
Stability and shelf-life commitments tied to expected delivery windows

Procurement consequence: even when the same API vendors serve multiple manufacturers, the supplier that matters for tenders is the finished-dose holder that can demonstrate PQ or national authorization and supply continuity.

How do API and finished-dose suppliers differ by region (US, EU, Africa, Asia)?

US and EU markets

Often involve manufacturers with regulatory filings and established distribution networks.
Many suppliers sell generics and authorized generics through established channels.

Endemic-market procurement (Africa and parts of Asia)

Tenders favor supply reliability, shelf-life, price, and regulatory acceptability for program use.
Manufacturing site qualification and batch release documentation drive vendor selection.

What patents or IP do suppliers need to consider for AL manufacturing?

AL is a legacy ACT with substantial generic availability. For supplier selection, IP considerations usually focus on:

Process patents (if any still active in certain jurisdictions)
Formulation patents (rare in AL compared with newer drug classes)
Regulatory exclusivities are usually less dominant for ACTs than for biologics, but pricing and tender commitments can still be constrained by branded supply history.

Supply decision impact: When manufacturing is generic and mature, IP risk is more about jurisdiction-specific process/formulation patents that affect manufacturing routes or particle-sizing steps than about broad method-of-use claims.

Supplier due diligence checklist for artemether-lumefantrine sourcing (API and FDF)

For API suppliers:

GMP certification for API manufacturing site
Detailed impurity profile alignment to regional regulatory expectations
Consistent batch release testing and CoA readiness
Traceability to artemisinin-derived feedstock and intermediate sources

For finished-dose suppliers:

Regulatory authorization status in target markets
Stability data covering the intended shelf-life for tender windows
Bioequivalence or comparability evidence, as required
Quality management system covering change control (API grade changes, supplier substitutions)
Ability to deliver under contract with realistic lead times

Which AL competitors do the same suppliers serve? (market structure)

AL supply networks often overlap with other ACTs such as:

Artemether-lumefantrine competitors (fixed-dose ACTs)
Neighboring artemisinin-based combinations used in the same programs
Shared API upstream artemisinin derivative manufacturing ecosystems

Commercial implication: Vendor leverage can increase when API lines are shared across multiple ACT SKUs. Contract terms and allocation rules matter during global artemisinin derivative supply disruptions.

Key Takeaways

Artemether-lumefantrine supply is a two-tier chain: artemisinin-derived APIs (artemether and lumefantrine) plus qualified finished-dose manufacturers.
Finished-dose suppliers win procurement largely through regulatory acceptability, stability evidence, and proven batch release capacity.
Lumefantrine API manufacturing and impurity control are typical constraints that can affect finished-dose availability and pricing.
Supplier qualification is usually driven by compliance readiness and supply reliability more than by formulation novelty.

FAQs

What is the most common strength of artemether-lumefantrine tablets supplied globally?
The standard adult-fixed combination is commonly supplied as 20 mg artemether/120 mg lumefantrine per tablet, with pediatric or weight-banded variants depending on program requirements.
Can the same API supplier support multiple ACT products?
Yes. Artemisinin-derived upstream and intermediate supply often supports multiple ACT formulations, but lumefantrine-specific impurity and crystallization requirements can still limit interchangeability.
What documents are most important for qualifying an AL supplier for procurement?
GMP certificates, API and finished-dose CoAs, stability reports aligned to requested shelf-life, and batch manufacturing records supporting release specifications.
What causes lead-time issues for artemether-lumefantrine shipments?
API supply constraints (especially for lumefantrine), longer crystallization/QA release cycles, and tender-specific regulatory batch release requirements.
How do contract manufacturers fit into AL supply?
CMOs are used to convert API into finished-dose tablets under the finished-dose holder’s quality system, enabling capacity expansion without the API holder needing full formulation infrastructure.

References

No sources were provided in the prompt, and this response does not include cited inline references.

Suppliers and packagers for generic pharmaceutical drug: ARTEMETHER; LUMEFANTRINE