Tenofovir Alafenamide Fumarate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Descovy, Vemlidy, Odefsey, Genvoya, Biktarvy

Category: Active Pharmaceutical Ingredient

Tenofovir alafenamide fumarate is a nucleotide reverse transcriptase inhibitor prodrug used in HIV and hepatitis B medicines. It is sourced by formulators, CDMOs and R&D teams.

Product Description:

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir, a nucleotide reverse transcriptase inhibitor; it is converted to the active form mainly inside cells, giving high levels there with less tenofovir in the blood than the older disoproxil prodrug. It is approved on its own for chronic hepatitis B in adults and in children aged 6 and older weighing at least 25 kg with compensated liver disease, and in combination tablets for the treatment of HIV-1 infection and, for one combination, HIV pre-exposure prophylaxis (reference brands: Vemlidy, Descovy, Odefsey, Genvoya, Biktarvy).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 26 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (2031). European Union: Patent expiry; entry not confirmed (2027).

Handling and quality points

Tenofovir alafenamide has a stereogenic phosphorus atom, and the approved substance is a single diastereomer, so the specification must limit the other diastereomer and related isomers. The phosphonamidate and ester groups are prone to hydrolysis, so ask for water content limits, stability data and packaging with moisture protection. Confirm that the supplier offers the hemifumarate used in the reference products rather than another salt or co-crystal form.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.