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Sofosbuvir bulk supplier for pharma manufacturers

Sofosbuvir 400 mg 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.

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📘 Sourcing Guide

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.

Sofosbuvir — third party manufacturing & bulk supply

Sofosbuvir 400 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Sofosbuvir listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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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