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Suppliers and packagers for generic pharmaceutical drug: SOFOSBUVIR
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SOFOSBUVIR
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 | SOVALDI | sofosbuvir | PELLETS;ORAL | 212480 | NDA | Gilead Sciences, Inc. | 61958-1504-1 | 60 PELLET in 1 PACKET (61958-1504-1) | 2019-08-28 |
| Gilead Sciences Inc | SOVALDI | sofosbuvir | PELLETS;ORAL | 212480 | NDA | Gilead Sciences, Inc. | 61958-1505-1 | 80 PELLET in 1 PACKET (61958-1505-1) | 2019-08-28 |
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671 | NDA | Gilead Sciences, Inc. | 61958-1501-1 | 28 TABLET, FILM COATED in 1 BOTTLE (61958-1501-1) | 2013-12-06 |
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671 | NDA | Gilead Sciences, Inc. | 61958-1503-1 | 28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1) | 2019-08-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Sofosbuvir: APIs, Intermediates, and Finished-Dose Manufacturing
Sofosbuvir is the direct-acting antiviral (DAA) active pharmaceutical ingredient (API) in hepatitis C virus (HCV) regimens. Supply is typically organized across (1) API manufacturers (and API-only traders/distributors), (2) intermediate producers feeding nucleotide synthesis, and (3) contract manufacturers producing finished-dose tablets for branded and generic markets.
Which companies supply sofosbuvir APIs?
Sofosbuvir API supply is concentrated in a limited set of large API producers and multiple China/India-based generic API suppliers. The following are widely cited commercial producers in public regulatory and supply-chain contexts, including WHO-prequalified and regulatory-linked manufacturing networks.
API manufacturers commonly associated with sofosbuvir
| Supplier / manufacturer | Base of operations | Supply role in market | Evidence present in public sources |
|---|---|---|---|
| Hetero Drugs (Hetero Healthcare) | India | API and finished-dose supply | WHO prequalification documentation and regulatory listings for HCV products that include sofosbuvir supply chains tied to major Indian manufacturers (WHO EML/qualifier-linked product histories). |
| Cipla | India | Generic finished-dose supply and contract manufacturing footprint | Public product dossiers and market presence for sofosbuvir-containing generics in multiple jurisdictions; typical pattern includes use of third-party APIs sourced from established API plants. |
| Mylan (now Viatris) | Global | Finished-dose and API procurement via supply network | Market role in DAA product supply and dossier-linked manufacturing relationships with API producers. |
| Hetero / Natco / Zydus-type large Indian generic manufacturers | India | Finished-dose supply; API procurement and internal intermediate capability | Multiple sofosbuvir-containing generic programs with manufacturing plants registered to handle nucleotide analog workflows. |
Which contract manufacturers produce finished-dose sofosbuvir tablets?
Finished-dose sofosbuvir products in global markets are produced by generic manufacturers under marketing authorizations, often using contract manufacturing organizations (CMOs) and in-house packaging. Supply tends to be driven by generic program makers that contract manufacturing for tablets and use multiple API sources for continuity.
Finished-dose manufacturing and packaging footprint
| Manufacturer (generic program sponsor) | Role | Typical dosage form | Notes on supply model |
|---|---|---|---|
| Major Indian generic sponsors (e.g., Hetero, Cipla, Mylan/Viatris, Natco and peers) | Sponsor and/or CMO oversight | Tablets | Uses multi-source API qualification to maintain continuity during rolling supply constraints. |
| Global specialty generics makers in DAAs | Finished-dose commercialization | Tablets | Often maintain both direct manufacturing capacity and CMO relationships in regulated jurisdictions. |
How do upstream intermediates affect supplier selection?
Sofosbuvir is a nucleotide prodrug with a multistep synthesis chain requiring tightly controlled intermediates, including nucleoside core and phosphoramidate-related transformations. That upstream complexity drives two supply realities:
- Qualified intermediate suppliers often become the effective bottleneck.
- API plant qualification depends on sustained impurity control and validated crystallization/form control at the nucleotide-prodrug stage.
In practice, finished-dose manufacturers frequently qualify at least one backup API source and multiple intermediate suppliers for continuity.
What are the main verified supply channels in the HCV market?
Regulatory-linked and program-linked channels
- WHO-prequalified product programs: WHO prequalification lists are frequently used as a proxy for “established” supply chains for quality-assured DAA products, which in turn map to a smaller group of API producers feeding those products. (Source: WHO prequalification program records for HCV DAAs containing sofosbuvir.) [1]
- EMA/FDA/NMPA dossier ecosystems: Authorization-linked manufacturing networks tend to concentrate API sourcing among repeat-appearance producers in documentation sets and inspection histories. (Source: WHO and regulator-linked manufacturing records, which are reflected across public product histories.) [1]
Commercial supply channels
- API distributors and traders: In practice, many buyers source sofosbuvir via intermediaries with validated supply documentation and COAs aligned to product quality agreements.
- Multi-sourcing: Generic sponsors use dual-qual or multi-qual API sources to reduce lead-time risk and to maintain lot-to-lot impurity profiles.
Which supplier groups are most likely to appear in a procurement process?
Procurement teams typically see three groups:
- Large generic API producers with internal nucleotide-analog capabilities.
- Specialist nucleotide intermediates producers feeding the API stage.
- Finished-dose generic program sponsors that qualify API lots for their marketing authorizations.
Procurement checklist used for sofosbuvir sourcing
| Supply item | Qualification focus | Why it matters for sofosbuvir |
|---|---|---|
| API lots | Impurity panel control and polymorph/form consistency | Nucleotide prodrug impurities are tightly constrained in QC specs. |
| Intermediate chain | Process validation and impurity carryover limits | Upstream deviations propagate into API impurity profile. |
| Documentation | COA, analytical methods, change control evidence | Direct regulator or purchaser audit trail is required for DAAs. |
Market note: why suppliers cluster
Sofosbuvir production has higher regulatory and process-intensity than many small-molecule generics due to:
- Multi-step synthesis and sensitive prodrug formation
- Impurity control requirements
- Need for stable supply of nucleotide intermediates
This structurally increases supplier concentration versus simple tablet manufacture.
Key Takeaways
- Sofosbuvir supply is concentrated among a small number of large API producers and major generic sponsors that control API qualification and finished-dose manufacturing continuity.
- Buyers typically source through validated API lots and program-qualified supply chains, with WHO-prequalified product records functioning as a practical map to established manufacturers. [1]
- Upstream intermediate capability is a binding constraint in sofosbuvir procurement due to prodrug-form impurity sensitivity and process validation needs.
FAQs
1) Are sofosbuvir API suppliers the same as finished-dose manufacturers?
No. Finished-dose companies often procure API from qualified API plants and then perform formulation, tablet compression, packaging, and final release under their authorization framework.
2) What credential matters most when selecting sofosbuvir API suppliers?
Regulator-linked quality documentation: impurity profile control, validated analytical methods, and a strong audit trail for batch release and change control. WHO-prequalification-linked supply chains are commonly used as a proxy filter. [1]
3) Which regions dominate sofosbuvir manufacturing supply?
India and China dominate the observed generic and API manufacturing ecosystem for DAAs, though global sourcing and distribution are common.
4) Why do sofosbuvir supply chains use multi-sourcing?
Sofosbuvir synthesis complexity and impurity sensitivity create continuity risk; qualified backup API sources reduce lot disruption risk.
5) What upstream step creates the largest supply bottleneck?
Intermediate production feeding the nucleotide prodrug chain, because intermediate availability and impurity control drive downstream API qualification outcomes.
References
[1] World Health Organization. (n.d.). WHO Prequalification of Medicines Program: Databases for quality-assured products (including hepatitis C DAAs containing sofosbuvir). World Health Organization. https://extranet.who.int/prequal/
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