Tenofovir & Emtricitabine Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: Tenofovir DF 300 mg + Emtricitabine 200 mg

Reference Brands: Truvada®(US/EU)

Category: Anti Viral

Tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg tablets, an HIV treatment backbone and oral PrEP option, for importers, distributors, hospitals and HIV programme buyers.

Product Description:

This once-daily tablet pairs two reverse transcriptase inhibitors: tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg. Both are activated inside cells to forms that stop HIV copying its RNA into DNA. Emtricitabine is a cytidine analogue close to lamivudine; tenofovir is a nucleotide analogue. Together they form the backbone of many antiretroviral regimens, and the same tablet is used alone as oral pre-exposure prophylaxis (PrEP), giving it two buyer groups: treatment programmes and prevention services.

For treatment it is always combined with a third active drug, such as an integrase inhibitor. For PrEP it is taken by HIV-negative people at substantial risk, daily or, under some guidelines, on an event-driven schedule for men who have sex with men. A negative HIV test is needed before PrEP and is repeated regularly, since use in undiagnosed infection breeds resistance. Both components act on hepatitis B, so stopping can cause a flare. Renal function is checked, and PrEP is not used when creatinine clearance is low.

Sourcing notes. Donor-funded programmes usually require WHO prequalification or approval by a stringent regulator, and the combination is on the WHO Model List of Essential Medicines. European labels express the tablet as emtricitabine 200 mg with tenofovir disoproxil 245 mg. Expect a CTD or ACTD dossier with bioequivalence and zone IVb stability for hot humid markets. Bottles of 30 tablets with desiccant are standard, kept dry at room temperature. Request a CoA per batch for both actives, the GMP certificate and a CoPP. It is prescription-only. State whether stock serves treatment or PrEP.