Last updated: April 24, 2026
What products and markets does HARVONI cover?
HARVONI is the fixed-dose combination of ledipasvir 90 mg and sofosbuvir 400 mg in a tablet. The brand is marketed by Gilead Sciences, Inc. (U.S.). In most countries, HARVONI supply is organized through Gilead’s commercial network, using contract manufacturing and regional distribution.
Who manufactures HARVONI drug product (tablets)?
Publicly available regulatory documentation for HARVONI identifies manufacturing sites for the drug substance (API) and drug product (finished tablets) that operate as contract manufacturing organizations (CMOs) supplying Gilead. The core manufacturing pattern is:
- Drug product (finished tablets): manufactured at designated commercial-scale sites listed in regulatory submissions.
- Drug substance (API): ledipasvir and sofosbuvir are produced by separate qualified API suppliers and then blended/formulated into the final tablet.
Who supplies the APIs (ledipasvir and sofosbuvir)?
HARVONI requires two distinct active pharmaceutical ingredients with separate supply chains:
- Sofosbuvir (API) suppliers: API manufacturing sites are identified in HARVONI regulatory filings and typically include one or more qualified API plants.
- Ledipasvir (API) suppliers: API manufacturing sites are identified separately from sofosbuvir because the chemistry and supply chain for ledipasvir differ.
Where does HARVONI get filled and packaged for distribution?
Commercial supply includes:
- Finished dose manufacturing (tablet compression/film-coating)
- Packaging and labeling at qualified sites
- Batch release through the marketing authorization holder’s release process (for Gilead markets, this is executed within the regulatory framework of each jurisdiction)
Supplier list (named organizations)
No reliable, citable, company-by-company supplier roster for HARVONI (drug substance and drug product) can be produced from the information present in this chat alone.
Key takeaways
- HARVONI is a ledipasvir/sofosbuvir fixed-dose tablet supplied through a regulated manufacturing network with distinct API and drug product streams.
- Supplier responsibility is typically split across API producers and CMO drug-product sites, with packaging and batch release managed under Gilead’s authorization framework in each market.
- A defensible “named supplier” list requires direct, jurisdiction-specific regulatory citations (manufacturer and site names per submission).
FAQs
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Is HARVONI manufactured by Gilead or contract manufacturers?
HARVONI supply is typically run through qualified manufacturers including contract manufacturing sites, with Gilead as the marketing authorization holder.
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Do ledipasvir and sofosbuvir share the same supplier chain?
No. They are manufactured as separate APIs with different process routes, so suppliers and plants are listed separately in regulatory materials.
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What determines whether a company qualifies as a HARVONI supplier?
Qualification is driven by regulatory filings listing the manufacturing sites for API and drug product, plus approval of manufacturing and batch release controls in each jurisdiction.
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Are packaging and labeling handled by the same site that makes the tablets?
Often they are separate or partially separate; packaging and labeling are performed at qualified sites under the same authorization framework.
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Can HARVONI supplier details vary by country?
Yes. Manufacturing and packaging sites can differ by market due to regulatory submissions and distribution logistics.
References (APA)
[1] FDA. (n.d.). Drug approval packages and related labeling/manufacturing information for HARVONI (ledipasvir and sofosbuvir). U.S. Food and Drug Administration.
[2] EMA. (n.d.). EPAR and product information for HARVONI (ledipasvir/sofosbuvir). European Medicines Agency.
[3] Gilead Sciences. (n.d.). HARVONI prescribing information. Gilead Sciences, Inc.
