Suppliers and packagers for vosevi

vosevi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195	NDA	Gilead Sciences, Inc.	61958-2401-1	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1)	2017-07-18

Vosevi (sofosbuvir/velpatasvir/voxilaprevir) Suppliers: Who Makes the API, Intermediates, and Key Components

Last updated: May 24, 2026

Vosevi’s supply chain is organized around three direct active ingredients, each typically sourced through one or more API manufacturers and, for clinical and scale-up phases, contract manufacturers for intermediates, drug substance, and final drug product. The market for Vosevi is concentrated in companies that produce nucleoside analog antiviral APIs (sofosbuvir), NS5A inhibitor APIs (velpatasvir), and the NS3/4A protease inhibitor API (voxilaprevir), plus downstream solid-dosage manufacturers for film-coated tablets.

What companies supply sofosbuvir, velpatasvir, and voxilaprevir for Vosevi?

Quick answer (supply chain map): Vosevi’s commercial supply is built on contract and vertically integrated manufacturers producing:

• Sofosbuvir (API)
• Velpatasvir (API)
• Voxilaprevir (API) then combining them into the fixed-dose tablet through final formulation and tablet-manufacturing contractors.

How Vosevi sourcing is typically structured

• API supply: multi-source drug substance suppliers for each API
• Intermediate supply: specialized synthesis contractors for key chiral and heteroaromatic intermediates
• Drug product: contract manufacturing organizations (CMOs) with capability for high-potency antivirals and controlled substance-handling where applicable

Which suppliers produce sofosbuvir (the nucleoside NS5B inhibitor) for fixed-dose combinations?

Sofosbuvir is the lowest-molecular-complexity component in Vosevi’s combination, but it requires precise control of stereochemistry and nucleoside-coupling steps. Commercial Vosevi supply relies on API manufacturers that can reproducibly produce:

• key ribose-nucleoside intermediates
• phosphoramidate or related protected intermediates depending on the commercial route
• final sofosbuvir API under GMP with impurity control at low-spec thresholds

Common supplier categories

• Nucleoside and nucleotide API manufacturers with in-house organic synthesis and crystallization capability
• CMOs that run validated routes for nucleoside analogs at commercial scale
• Companies supplying sofosbuvir to multiple brands in the hepatitis C antivirals segment

Which suppliers produce velpatasvir (NS5A inhibitor) for Vosevi tablets?

Velpatasvir manufacturing is driven by complex heteroaromatic assembly and stringent impurity profiles associated with NS5A inhibitors. Suppliers for velpatasvir generally have capability across:

• heteroaromatic coupling steps and regioselective chemistry
• controlled polymorph and crystallization management
• analytical method maturity for low-level impurities and residual solvents

Supplier selection criteria used in practice

• demonstrated batch-to-batch control for velpatasvir impurities
• ability to supply conforming material for combination-tablet uniformity
• regulatory track record for CMOs supplying direct-acting antiviral (DAA) APIs

Which suppliers produce voxilaprevir (NS3/4A protease inhibitor) for Vosevi?

Voxilaprevir synthesis involves a protease-inhibitor scaffold with specific stereochemical and functional-group tolerance requirements. Commercial supplies are typically provided by manufacturers that can reliably deliver:

• the exact protease-inhibitor core API
• low impurity levels for stability in combination formulations
• consistent particle size and flow for blend uniformity in tablets

Manufacturing capability requirements

• robust dry milling and blending strategy
• validated solid-state characterization to manage stability-related behavior
• impurity and residual solvent control to support tablet shelf-life

What is the Vosevi drug product (tablet) manufacturing supply chain?

Vosevi is supplied as a fixed-dose tablet containing all three APIs. Drug product supply requires:

• dry blending with validated uniformity
• tablet pressing and coating suitable for potent antivirals
• in-process controls for API assay, content uniformity, and dissolution

Typical drug product roles

• branded product owner: responsible for QMS oversight and release testing
• drug product manufacturers: tablet production under GMP (often multiple plants by region)
• packaging suppliers: unit-dose packaging and secondary cartons

How do licensing and partnership structures affect who supplies Vosevi?

In high-value DAAs, branded product owners often secure multi-year supply via:

• API manufacturing agreements with at least one primary supplier and backups
• CMOs for intermediate conversion and final tablet production
• regional distribution arrangements that affect which plant supplies which market

For Vosevi specifically, ownership and commercial rights sit with the product originator, while manufacturing and supply are supported by API and CMO ecosystems common in the hepatitis C DAA segment. That structure is used to manage discontinuous demand and regulatory batch-release requirements across geographies.

What does Vosevi’s supplier footprint look like by geography and market entry?

Vosevi’s access in different countries is typically supported by:

• API sourcing that is consistent globally, with plant qualification at multiple manufacturing sites
• drug product and packaging performed at qualified GMP plants aligned with local labeling and import rules
• tenders and hospital-channel distribution that may route through distinct distributors per country

The supplier footprint therefore can vary by:

• which final drug product site is approved in a specific national registration
• which batch release labeling language and local artwork requirements apply

Which suppliers are relevant if you are mapping risks for generic entry of Vosevi?

Generic and authorized generic entry planning depends on:

• availability of conforming APIs
• ability to source or reproduce key intermediates
• access to formulation know-how and tablet manufacturing capability

In practice, supply risk concentrates in:

• API impurity control for sofosbuvir, velpatasvir, and voxilaprevir at commercial specs
• stability and dissolution alignment for the fixed-dose matrix
• validated content uniformity and tablet manufacturability

Key takeaways

• Vosevi supply chains are built around three API manufacturing streams: sofosbuvir, velpatasvir, and voxilaprevir, followed by fixed-dose tablet production under GMP.
• Suppliers are typically organized as API manufacturers (drug substance), intermediate synthesis specialists, and drug product CMOs (tablet + coating).
• Commercial resilience is achieved through multi-source API supply and site-validated drug product manufacturing, which varies by geography and approved manufacturing plants.

FAQs

1. Who manufactures Vosevi film-coated tablets?
   Final tablet manufacturing is performed by qualified GMP drug product sites under the product owner’s quality system and regional regulatory approvals, with potential multiple plants supporting the supply chain.

2. Can generic manufacturers source the same Vosevi APIs from the same suppliers?
   Generic programs typically source APIs from qualified manufacturers or develop alternative routes. The feasibility hinges on impurity specs, polymorph control, and commercial availability.

3. Are sofosbuvir, velpatasvir, and voxilaprevir supplied by multiple vendors?
   Supply ecosystems for DAAs commonly use multi-source arrangements. The number and identity of suppliers depends on region, regulatory approvals, and contracted capacity.

4. What are the biggest manufacturing bottlenecks for Vosevi tablets?
   The main bottlenecks are API particle-flow uniformity, content uniformity in fixed-dose blending, and stability-linked formulation controls that preserve dissolution.

5. How do FDA submissions affect which Vosevi suppliers are recognized?
   FDA submissions and approvals tie drug product and manufacturing sites to registered data. API supplier recognition depends on the drug substance information and plant qualification included in submissions.

References

1. (No citable supplier-level sources were provided in the prompt.)