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 film-coated tablets, a pan-genotypic NS5B polymerase inhibitor used in combination regimens for chronic hepatitis C. For national programmes, tender buyers, importers and distributors.

Product Description:

Sofosbuvir is a direct-acting antiviral for hepatitis C. It is a nucleotide prodrug: liver cells convert it to an active triphosphate that the viral NS5B polymerase builds into new RNA, which stops the chain growing. Because NS5B is highly conserved, it is active against all major genotypes and has a high barrier to resistance. It is supplied as 400 mg film-coated tablets, the standard adult dose. Sofosbuvir appears on the WHO Model List of Essential Medicines.

Sofosbuvir is never used alone. It is combined with another direct-acting antiviral such as daclatasvir, ledipasvir or velpatasvir, sometimes with ribavirin, usually for 12 weeks; regimen and duration depend on genotype, cirrhosis and treatment history. The tablet is swallowed once a day, with or without food. The key interaction is amiodarone, which can cause serious slowing of the heart rate. Strong P-gp inducers such as rifampicin, carbamazepine and St John's wort cut its levels and must not be combined. Patients are tested for hepatitis B first.

Sourcing notes. Donor-funded and national elimination programmes often require WHO prequalification or approval by a stringent regulatory authority. Otherwise, registration needs a CTD dossier with bioequivalence data against the reference product. Patent and licence status varies by country, so check that supply to your market is lawful. Ask for zone IVb stability data for hot, humid climates, and confirm bottle with desiccant or aluminium blister. Each batch should come with its CoA, alongside the GMP certificate and a CoPP. It is prescription-only, at room temperature. Specify pack count, quantity, partner molecule and destination.