Sofosbuvir Suppliers & Bulk Manufacturers
Available Forms: Film-coated Tablets
Available Strengths: 400 mg
Reference Brands: Sovaldi® (EU & US)
Category: Hepatitis
Sofosbuvir 400 mg Tablets are oral direct-acting antivirals used in combination regimens for treating chronic Hepatitis C. Manufactured under EU-GMP and USFDA-compliant facilities, they are available for B2B supply, tenders, and licensing with full CTD dossiers and bioequivalence data to support registration in regulated markets. Sofosbuvir is available in Film-coated Tablets and strengths such as 400 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Sofosbuvir is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Sofosbuvir can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
Product Description:
Sofosbuvir Tablets are direct-acting antiviral agents (DAAs) used in combination therapy for the treatment of chronic Hepatitis C (HCV) across multiple genotypes. A nucleotide analog NS5B polymerase inhibitor, Sofosbuvir is available in 400 mg strength and forms the backbone of several pan-genotypic HCV regimens. Manufactured under EU-GMP or USFDA-approved facilities, Sofosbuvir is ideal for B2B licensing, tender supply, and distribution in regulated and semi-regulated markets. Offered with full CTD dossier, bioequivalence data, and stability studies, it supports rapid registration and commercialization in global markets. Available as a standalone API or FDF with partner molecules.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Sofosbuvir is used for the treatment of chronic hepatitis C virus (HCV) infection. It is combined with other antiviral agents to lower viral load and achieve sustained virologic response, leading to complete viral clearance.
It is made from the active ingredient sofosbuvir, an NS5B nucleotide polymerase inhibitor that blocks the replication of hepatitis C virus.
The main trade name is Sovaldi in the USA, EU, and UK, along with multiple licensed generics in India and other regions.
Sovaldi is manufactured by Gilead Sciences. Licensed generic versions are produced by several authorized manufacturers in India and other countries.
The generic name is sofosbuvir.
The primary brand name is Sovaldi, along with various licensed generic brands depending on the region.
It is manufactured by Gilead Sciences in the USA and by licensed generic manufacturers in India and other global regions.
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