Tenofovir Disoproxil Fumarate(TDF) Tablets 300 mg Suppliers & Bulk Manufacturers

Available Forms: Oral tablets

Available Strengths: 300 mg

Reference Brands: Viread (EU & US)

Category: Anti Viral

Tenofovir disoproxil fumarate 300 mg tablets, a single-ingredient antiviral for chronic hepatitis B and for HIV regimens, for importers, distributors, hospitals and public health purchasing teams.

Product Description:

Tenofovir disoproxil fumarate (TDF) is an oral prodrug of tenofovir, a nucleotide analogue active against both HIV and hepatitis B virus. Inside cells it becomes tenofovir diphosphate, which blocks HIV reverse transcriptase and the hepatitis B polymerase and ends the growing viral DNA chain. This page covers the single-ingredient 300 mg tablet, taken once a day. It is the standard tablet for hepatitis B monotherapy, and it lets HIV clinicians build regimens, or extend the dosing interval in reduced kidney function, where a fixed-dose combination does not fit.

In chronic hepatitis B it is taken alone, usually for years, by adults and by children above the age set in the local label. In HIV it is always combined with other antiretrovirals. Creatinine clearance and serum phosphate are checked before and during treatment, because proximal tubular injury can occur, and bone mineral density may fall. Patients with hepatitis B are warned that stopping can trigger a severe flare. Everyone is tested for both HIV and hepatitis B before the first dose.

Sourcing notes. The 300 mg figure refers to the fumarate salt; some labels describe the same tablet as 245 mg tenofovir disoproxil, so match the declared strength to your registration. Expect a CTD or ACTD dossier with bioequivalence data and zone IVb stability where relevant. HDPE bottles with a desiccant, stored dry at room temperature, are usual. Ask for a CoA per batch with assay, dissolution and related substances, the GMP certificate and a CoPP. It is prescription-only. State bottle count, label language and intended programme.