Sofosbuvir / Ledipasvir Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: Sofosbuvir 400 mg & Ledipasvir 90 mg

Reference Brands: Harvoni®(EU & US)

Category: Anti Viral

Sofosbuvir 400 mg and ledipasvir 90 mg tablets, a once-daily direct-acting antiviral combination for chronic hepatitis C genotypes 1, 4, 5 and 6. For hepatitis programmes, tender buyers, hospitals and importers.

Product Description:

This tablet combines sofosbuvir 400 mg, a nucleotide analogue that blocks the hepatitis C virus NS5B polymerase, with ledipasvir 90 mg, an inhibitor of the NS5A protein the virus needs for replication and assembly. Together they form an all-oral, interferon-free regimen of one film-coated tablet a day. The fixed-dose form made this pairing practical in national hepatitis C programmes: no injections, no ribavirin for most patients, and a short, fixed course that suits decentralised care.

It is approved for chronic hepatitis C genotypes 1, 4, 5 and 6, usually for 12 weeks, with eight weeks possible in some treatment-naive patients without cirrhosis. It does not cover genotypes 2 and 3 well, which is why WHO now favours pangenotypic regimens. Ledipasvir absorption falls with acid-reducing drugs, so antacids, H2 blockers and proton pump inhibitors need careful timing. Amiodarone is a serious hazard because of severe bradycardia, and strong P-gp inducers such as rifampicin must be avoided. Screen for hepatitis B first, as it can reactivate.

Sourcing notes. Patents and voluntary licences decide where generic versions may be sold, so confirm your country is in a licensed territory, or that no blocking patent applies, before ordering. Tender buyers often need WHO prequalification or approval by a stringent regulatory authority; ask for the evidence. Request a batch CoA covering assay, dissolution and impurities of each active, along with the bioequivalence study, GMP certificate and CoPP. Tablets come in bottles with desiccant or in blisters, with zone IVb data and no cold chain. State course pack and label language.