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Sofosbuvir | CAS No: 1190307-88-0 | GMP-certified suppliers
A medication that supports broad‑genotype chronic hepatitis C treatment, including in HIV co‑infection and varied cirrhosis stages, when used as part of combination antiviral regimens.
Therapeutic categories
Anti-Infective AgentsAntiinfectives for Systemic UseAntiviral AgentsAntivirals for Systemic UseAntivirals for treatment of HCV infectionsBCRP/ABCG2 Substrates
Generic name
Sofosbuvir
Molecule type
small molecule
CAS number
1190307-88-0
DrugBank ID
DB08934
Approval status
Approved drug
ATC code
J05AP08
Primary indications
- Sofosbuvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients
- Depending on the level of cirrhosis or decompensation, combination therapy can also include either ribavirin alone or ribavirin and peg-interferon alfa
- When used in combination with , sofosbuvir has the following indications: treatment of genotypes 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
- In combination with for genotype 1 infection with decompensated cirrhosis
Product Snapshot
- Oral small‑molecule API supplied in multiple solid formulations including tablets, granules, and pellets
- Primary use is as a component of combination regimens for chronic hepatitis C across genotypes, including use in co-infected and cirrhotic populations per regimen design
- Approved in the US, EU, and Canada
Clinical Overview
Sofosbuvir (CAS 1190307-88-0) is a pyrimidine nucleotide analog used as a core component of direct‑acting antiviral regimens for chronic hepatitis C virus infection across genotypes 1 to 6. It is indicated for adults with or without compensated cirrhosis and, when combined with ribavirin or peg‑interferon alfa, can be used in specific settings such as decompensated cirrhosis or post‑transplant management. Sofosbuvir is also used in patients co‑infected with HIV when part of guideline‑supported combination therapy. Clinically, it is incorporated into fixed‑dose combinations such as sofosbuvir‑ledipasvir (Sovaldi and Harvoni) for genotypes 1, 4, 5, and 6, and sofosbuvir‑velpatasvir (Epclusa), which covers all major HCV genotypes.
Sofosbuvir is a prodrug that undergoes intracellular activation to the uridine nucleotide analog triphosphate GS‑461203. The active metabolite selectively inhibits the HCV NS5B RNA‑dependent RNA polymerase by acting as an obligate chain terminator. Binding within the GDD catalytic motif and coordination with two Mg2+ ions disrupt polymerase activity and prevent viral RNA synthesis. The compound shows a high barrier to resistance, although the NS5B S282T substitution can reduce susceptibility.
Following oral dosing, sofosbuvir is rapidly absorbed and extensively metabolized, with the inactive metabolite GS‑331007 predominantly renally eliminated. It does not meaningfully prolong QTc at supratherapeutic doses. As part of combination antiviral therapy, it is generally well tolerated, with headache and fatigue being the most frequent adverse effects. Safety in decompensated cirrhosis depends on the accompanying agents, particularly ribavirin.
Notable branded products include Sovaldi, Harvoni, and Epclusa, which support different genotype and disease‑stage indications. When sourcing sofosbuvir API, procurement teams should ensure compliance with pharmacopeial specifications, control of stereochemical integrity, and verification of impurity profiles consistent with global regulatory expectations.
Sofosbuvir is a prodrug that undergoes intracellular activation to the uridine nucleotide analog triphosphate GS‑461203. The active metabolite selectively inhibits the HCV NS5B RNA‑dependent RNA polymerase by acting as an obligate chain terminator. Binding within the GDD catalytic motif and coordination with two Mg2+ ions disrupt polymerase activity and prevent viral RNA synthesis. The compound shows a high barrier to resistance, although the NS5B S282T substitution can reduce susceptibility.
Following oral dosing, sofosbuvir is rapidly absorbed and extensively metabolized, with the inactive metabolite GS‑331007 predominantly renally eliminated. It does not meaningfully prolong QTc at supratherapeutic doses. As part of combination antiviral therapy, it is generally well tolerated, with headache and fatigue being the most frequent adverse effects. Safety in decompensated cirrhosis depends on the accompanying agents, particularly ribavirin.
Notable branded products include Sovaldi, Harvoni, and Epclusa, which support different genotype and disease‑stage indications. When sourcing sofosbuvir API, procurement teams should ensure compliance with pharmacopeial specifications, control of stereochemical integrity, and verification of impurity profiles consistent with global regulatory expectations.
Identification & chemistry
| Generic name | Sofosbuvir |
|---|---|
| Molecule type | Small molecule |
| CAS | 1190307-88-0 |
| UNII | WJ6CA3ZU8B |
| DrugBank ID | DB08934 |
Pharmacology
| Summary | Sofosbuvir is a nucleotide analog prodrug that, once metabolized to its active triphosphate form, targets the HCV NS5B RNA‑dependent RNA polymerase. It is incorporated into viral RNA and acts as a chain terminator, blocking replication across HCV genotypes. As a direct‑acting antiviral, its activity can be reduced by NS5B resistance mutations such as S282T. |
|---|---|
| Mechanism of action | Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator [synthesis, A7533]. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material [A19638, FDA Label]. |
| Pharmacodynamics | Sofosbuvir acts against HCV and is categorized as a direct-acting antiviral agent (DAA). At a dose 3 times the recommended dose, sofosbuvir does not prolong QTc to any clinically relevant extent [FDA Label]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| RNA-dependent RNA-polymerase | Hepatitis C Virus | inhibitor |
ADME / PK
| Absorption | When given orally, sofosbuvir reaches its maximum plasma concentration in about 0.5 to 2 hours with a maximal concentration (Cmax) of 567 ng/mL [FDA Label]. |
|---|---|
| Half-life | Sofosbuvir has a terminal half life of 0.4 hours [FDA Label]. |
| Protein binding | Sofosbuvir is approximately 61-65% bound to human plasma proteins [FDA Label]. |
| Metabolism | In vitro studies in human liver microsomes showed that sofosbuvir was an efficient substrate for Cathepsin A (Cat A) and carboxyl esterase 1 (CES1). Sofosbuvir was cleaved by CatA and CES1 and subsequent activation steps included amino acid removal by histidine triad nucleotide-binding protein 1 (HINT1) and phosphorylation by uridine monophosphate-cytidine monophosphate (UMP-CMP) kinase and nucleoside diphosphate (NDP) kinase. In vitro data indicated that Cat A preferentially hydrolysed sofosbuvir (the S-diastereomer) while CES1 did not exhibit stereoselectivity . |
| Route of elimination | Sofosbuvir is eliminated by three routes: urine ( 80%), feces (14%), and respiration (2.5%); however, elimination through the kidneys is the major route [FDA Label]. |
| Volume of distribution | The volume of distribution for sofosbuvir has yet to be determined [FDA Label]. |
| Clearance | The clearance of sofosbuvir has yet to be determined [FDA Label]. |
Formulation & handling
- Oral small‑molecule prodrug suitable for solid‑dose formulations; moderate aqueous solubility may require particle‑size control or solubility‑enhancing excipients.
- Chemically stable nucleoside analog that is moisture‑sensitive; store and handle as a dry solid to limit hydrolytic degradation.
- Food has minimal impact on exposure, allowing flexible administration without special formulation for food effects.
Regulatory status
| Lifecycle | The API remains in a protected phase across its key markets, with multiple U.S. patents extending exclusivity through 2028–2030. With commercialization in the US, Canada, and the EU, the product is positioned in a late‑patent but still non-generic market stage pending expiries at the end of the decade. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Sofosbuvir is supplied primarily by a single originator manufacturer, with branded products such as Epclusa marketed across the US, EU, and Canada. Its market presence is well established in major regulated regions, supported by an extensive patent portfolio in the United States. Patent expiries between 2028 and 2030 indicate that generic competition is expected to emerge as these protections lapse. |
|---|
Safety
| Toxicity | Sofosbuvir, as a single agent, has very mild toxicity. The most common adverse reactions are headache and fatigue. The FDA Label currently warns of a risk of symptomatic bradycardia when Epclusa is used in combination with amiodarone [FDA Label]. |
|---|
High Level Warnings:
- Exhibits low intrinsic toxicity
- Reported adverse effects are primarily mild CNS-related events such as headache and fatigue
- Co‑administration with amiodarone is associated with a risk of severe symptomatic bradycardia, requiring heightened monitoring in combination-use development settings
Sofosbuvir is a type of Anti-HCV agents
Anti-HCV agents, belonging to the pharmaceutical API category, are potent medications used in the treatment of Hepatitis C Virus (HCV) infection. Hepatitis C is a viral disease that affects the liver and can lead to severe health complications if left untreated. Anti-HCV agents work by targeting specific mechanisms involved in the replication and spread of the HCV virus within the body.
These pharmaceutical APIs are designed to inhibit various steps of the viral lifecycle, including viral entry into liver cells, viral RNA replication, and assembly of new viral particles. By disrupting these critical processes, anti-HCV agents effectively reduce the viral load in the body, slow down disease progression, and ultimately improve patient outcomes.
The development of anti-HCV agents has revolutionized the management of HCV infection, offering new hope for patients. These APIs are often used in combination with other antiviral drugs to form highly effective treatment regimens known as direct-acting antiviral (DAA) therapies. DAAs have significantly higher cure rates compared to older treatment options, such as interferon-based therapies, and are associated with fewer side effects.
The pharmaceutical industry has made significant advancements in the development of anti-HCV agents, resulting in a diverse range of APIs with varying mechanisms of action. This diversity allows healthcare professionals to tailor treatment plans based on the specific characteristics of each patient's HCV infection, maximizing the chances of successful viral eradication.
In summary, anti-HCV agents are a crucial category of pharmaceutical APIs used in the treatment of Hepatitis C. Their targeted action against the HCV virus has revolutionized the management of this chronic infection, providing more effective and better-tolerated treatment options for patients.
Sofosbuvir API manufacturers & distributors
Compare qualified Sofosbuvir API suppliers worldwide. We currently have 17 companies offering Sofosbuvir API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, FDA, ISO9001, MSDS, USDMF | 229 products |
| Beijing Huikang Boyuan | Producer | China | China | CoA, USDMF | 10 products |
| Changzhou Pharma | Producer | China | China | CoA, USDMF | 9 products |
| Dalian Wista Pharma Co Lt... | Producer | China | China | CoA | 16 products |
| Hangzhou Coben Pharmaceut... | Producer | China | China | CoA, GMP, ISO9001 | 7 products |
| Hangzhou ROYALL Import & ... | Buyer | China | China | CoA | 1 products |
| Hetero Labs | Producer | India | India | CoA, GMP, WC | 90 products |
| Honour Lab | Producer | India | India | CoA, GMP, WC | 30 products |
| Laurus Labs | Producer | India | India | CoA, GMP, USDMF, WC | 50 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| MSN Life Sciences | Producer | India | India | CoA, WC | 46 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Shanghai Acebright | Producer | China | China | CoA | 23 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 757 products |
| Zhejiang Hongyuan | Producer | China | China | CoA | 7 products |
When sending a request, specify which Sofosbuvir API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Sofosbuvir API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Sofosbuvir API
Sourcing
What matters most when sourcing GMP-grade Sofosbuvir?
Key considerations include confirming GMP compliance within the US, EU, or Canadian regulatory frameworks and verifying that the material originates from an approved source. Because Sofosbuvir is supplied mainly by a single originator, supply chain traceability and documentation are essential. Patent protections in major markets through 2028–2030 also require attention to lawful sourcing and intended use.
Which documents are typically required when sourcing Sofosbuvir API?
Request the core API documentation set: CoA (17 companies), USDMF (6 companies), WC (5 companies), GMP (5 companies), ISO9001 (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Sofosbuvir API?
Known or reported manufacturers for Sofosbuvir: Apino Pharma Co., Ltd., Sinoway industrial Co.,Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Sofosbuvir API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Sofosbuvir manufacturers?
Audit reports may be requested for Sofosbuvir: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Sofosbuvir API on Pharmaoffer?
Reported supplier count for Sofosbuvir: 17 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Sofosbuvir API?
Production countries reported for Sofosbuvir: China (10 producers), India (6 producers), Japan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Sofosbuvir usually hold?
Common certifications for Sofosbuvir suppliers: CoA (17 companies), USDMF (6 companies), WC (5 companies), GMP (5 companies), ISO9001 (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Sofosbuvir (CAS 1190307-88-0) used for?
Sofosbuvir is used as a core component of direct‑acting antiviral regimens for chronic hepatitis C virus infection across genotypes 1 to 6. It is indicated for adults with or without compensated cirrhosis and, in combination with agents such as ribavirin or peg‑interferon alfa, can be used in settings like decompensated cirrhosis or post‑transplant management. It is also used in guideline‑supported combinations for patients co‑infected with HIV.
Which therapeutic class does Sofosbuvir fall into?
Sofosbuvir belongs to the following therapeutic categories: Anti-Infective Agents, Antiinfectives for Systemic Use, Antiviral Agents, Antivirals for Systemic Use, Antivirals for treatment of HCV infections. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Sofosbuvir mainly prescribed for?
The primary indications for Sofosbuvir: Sofosbuvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients, Depending on the level of cirrhosis or decompensation, combination therapy can also include either ribavirin alone or ribavirin and peg-interferon alfa, When used in combination with , Sofosbuvir has the following indications: treatment of genotypes 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, In combination with for genotype 1 infection with decompensated cirrhosis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Sofosbuvir work?
Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), Sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator [synthesis, A7533]. More specifically, Sofosbuvir prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material [A19638, FDA Label].
What should someone know about the safety or toxicity profile of Sofosbuvir?
Sofosbuvir has a low intrinsic toxicity profile and is generally well tolerated, with headache and fatigue being the most common adverse effects. It does not meaningfully prolong QTc at supratherapeutic doses. A clinically important interaction occurs with amiodarone, where co‑administration has been associated with severe symptomatic bradycardia and requires close monitoring. Safety in decompensated cirrhosis depends on the other agents used in combination, particularly ribavirin.
What are important formulation and handling considerations for Sofosbuvir as an API?
Sofosbuvir is formulated as an oral small‑molecule prodrug suitable for solid‑dose products, and its moderate aqueous solubility may require particle‑size control or solubility‑enhancing excipients. It is a moisture‑sensitive nucleoside analog, so it should be stored and processed as a dry solid to limit hydrolytic degradation. Food has minimal impact on exposure, allowing flexible administration without food‑dependent formulation adjustments.
Is Sofosbuvir a small molecule?
Sofosbuvir is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Sofosbuvir?
Sofosbuvir is chemically stable but sensitive to moisture, so it should be stored and handled as a dry solid to limit hydrolytic degradation. Its moderate aqueous solubility may require particle‑size control or solubility‑enhancing excipients in solid oral formulations. Food has minimal impact on exposure, and no special stability considerations related to food effects are noted.
Regulatory
Where is Sofosbuvir approved or in use globally?
Sofosbuvir is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Sofosbuvir right now?
Sofosbuvir is authorized for use in Canada, the United States, and the European Union through their respective regulatory pathways. In these regions, it is regulated as a prescription antiviral with established quality, safety, and efficacy standards. Its patent protection is governed by jurisdiction‑specific intellectual property laws, which define the terms and duration of exclusivity for the molecule and associated formulations.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Sofosbuvir procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Sofosbuvir. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Sofosbuvir included in the PRO Data Insights coverage?
PRO Data Insights coverage for Sofosbuvir: 496 verified transactions across 149 suppliers and 130 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Sofosbuvir?
Market report availability for Sofosbuvir: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
