Suppliers and packagers for coartem

coartem

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

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

Suppliers and packagers for coartem

Last updated: June 5, 2026

COARTEM Suppliers: Who Manufactures Artemether–Lumefantrine for Global and US Markets?

COARTEM is the brand name for the artemisinin combination therapy artemether–lumefantrine (AL). The supply chain is split between (1) global brand ownership and licensing, (2) contract manufacturing of the finished dosage form and packaging, and (3) upstream suppliers for APIs and excipients used in tablets. Public sourcing detail is limited, and meaningful supplier identification depends on national registration/marketing-authorisation records and Orange Book-style listings for US demand.

What companies supply COARTEM tablets and bulk artemether–lumefantrine?

COARTEM is marketed by Novartis and typically produced through Novartis’ manufacturing network and licensed contract manufacturers, with upstream API sourced through qualified API producers for artemether and lumefantrine and for key excipients. In practice, the named suppliers that matter to procurement teams are the entities listed as manufacturers on the finished-product marketing authorization/labeling (and, in the US, the NDA/label section).

Typical procurement-facing supplier categories

• Finished product manufacturer: entity named on the COARTEM package insert/label as manufacturing site(s).
• Marketing-authorisation holder/licensor: entity controlling regulatory filings (label ownership and product specification).
• API suppliers: registered/qualified suppliers for artemether and lumefantrine (often not publicly named on consumer-facing labeling).
• Packaging and secondary packaging: sometimes separate contract packagers per market.

How do COARTEM suppliers differ by market (US vs endemic-country tenders)?

US (FDA-labeled) supply

• The US label identifies the manufacturer(s) and often the site(s) responsible for manufacturing and packaging.
• For procurement and compliance, the label’s “Manufactured for/Distributed by” and “Manufactured by” lines are the primary supplier source.

Endemic-country procurement

• UNICEF/Global Fund and national tenders require technical product dossiers and WHO prequalification documentation for AL fixed-dose combinations.
• Supplier identity often maps to the marketing authorization holder and the local tender-defined “manufacturer” entity, which can be the brand holder or a licensed generic/authorized manufacturer producing under supply agreements.

What patents protect COARTEM manufacturing and formulation suppliers?

COARTEM’s commercial manufacturing and formulation are protected by a portfolio of product patents and related process and formulation patents historically associated with artemisinin combination fixed-dose tablets. Supplier strategy is driven less by patent scope on the excipient level and more by whether a manufacturer is authorized or can lawfully produce and market the product in a given jurisdiction.

Which jurisdictions control COARTEM supplier manufacturing rights?

• US: patent listings and any regulatory exclusivities affect whether alternate AL fixed-dose combination products can enter.
• EMEA and endemic countries: patent enforcement and regulatory authorisation differ, often allowing authorized generics for public health programs even when brand patents remain in force.

How do authorized-generic programs affect supplier lists?

• When the originator authorizes secondary manufacturers, supplier identity shifts from a single Novartis site to multiple contract sites operating under licenses and quality agreements.
• For public-sector procurement, the authorized manufacturer list is typically reflected in WHO/UN tender documentation rather than on retail packaging.

What is the Orange Book status of COARTEM and how does it affect suppliers?

COARTEM is an older antimalarial brand with a fixed-dose combination tablet. In practice, US exclusivity and patent coverage determine whether other firms can market “AB-rated” alternatives. For supplier identification, Orange Book-style listings matter because they map patents to specific NDA/strength/dosage-form combinations and can drive which manufacturers can make an equivalent.

Featured-snippet answer: COARTEM’s supplier landscape in the US is anchored to the NDA label and the manufacturing sites listed there; patent listings primarily affect who can launch competing products, not who can physically manufacture.

Who are the upstream API and excipient suppliers used in COARTEM tablets?

Artemether–lumefantrine manufacturing has two critical upstream elements:

1. APIs: artemether and lumefantrine (often sourced from multiple global API suppliers depending on regulatory qualification).
2. Core excipients and formulation components: tablet excipients and film-coating materials, selected for stability, bioavailability, and dissolution.

What upstream inputs determine qualification for COARTEM supply?

• API polymorph and particle size specifications (affecting dissolution and stability)
• Impurity profiles and residual solvents
• Excipient grade and functional performance (binder/disintegrant/coating systems)

Procurement-facing consequence: Even when a contract manufacturer can build the tablet, it typically cannot legally use unqualified API and must source from approved supply chains.

Which contract manufacturers and packagers supply COARTEM?

Concrete supplier identification requires the labeled manufacturing site(s) for the specific COARTEM strength and dosage form (e.g., tablet strengths). Without market-specific label inspection, supplier lists cannot be reliably enumerated to named legal entities.

How to use COARTEM labeling to identify real suppliers

For each COARTEM presentation:

• Extract the “Manufactured by” line and site address.
• Extract any “Packaged by” line if separate.
• Map those entities to corporate legal names for vendor qualification.

Procurement action: Vendor due diligence should use the label manufacturer entity, not the brand owner, as the contractual counterparty for supply and quality agreements.

How many COARTEM suppliers exist globally and what drives changes?

The number of qualified suppliers for fixed-dose combinations changes due to:

• GMP capacity expansions and site transfers
• Regulatory inspection outcomes and quality deviations
• Market-specific packaging requirements
• Authorized generic or licensed manufacturing rollouts in public-sector programs

Business implication: Supplier continuity is often managed via multiple qualified sites rather than a single plant.

Key supplier map (what you can conclude without label-level extraction)

• Brand/licensor: Novartis is the established brand owner for COARTEM.
• Finished product: manufactured through Novartis and/or authorized contract manufacturing sites that are identified on local labels and regulatory filings.
• Upstream APIs and excipients: sourced from qualified API and excipient suppliers; specific company names are typically controlled by qualification dossiers and may not appear on retail labeling.

Key Takeaways

• COARTEM supply is managed through a combination of brand ownership (Novartis) and qualified manufacturing/packaging sites listed on national labels and regulatory dossiers.
• Publicly usable supplier identification for procurement is anchored to the finished-product label “manufactured by/packaged by” entities for each specific COARTEM presentation.
• Upstream API and excipient suppliers are controlled by qualification requirements for impurity profile, polymorph/particle size, and stability, so supplier switching is typically limited to pre-approved supply chains.

FAQs

1) Who manufactures COARTEM tablets in the United States?
Identify the “Manufactured by” and “Packaged by” entities on the US COARTEM label for the specific strength.

2) Are there authorized generic COARTEM manufacturers for malaria control programs?
Yes in many jurisdictions where public-health procurement uses authorized supply sources under licensing or regulatory acceptance frameworks.

3) Can other companies contract manufacture artemether–lumefantrine tablets under the COARTEM brand?
Only if licensed/authorized and aligned with the COARTEM regulatory specification and validated manufacturing processes.

4) Do API suppliers change more frequently than finished-product manufacturers?
API sourcing can be diversified within the bounds of qualification, while finished-product sites typically change more slowly due to GMP and regulatory transfers.

5) What documentation should procurement request to qualify a COARTEM supplier?
Manufacturing site GMP evidence, product specification, batch records for the relevant presentation, and regulatory marketing authorization references for the supplied market.

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References (APA)

No specific COARTEM supplier entity list or label/manufacturer citations were provided in the input, so no sourced supplier names can be enumerated without risking incorrect attributions.