TAF + Emtricitabine + Darunavir + Cobicistat Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: Darunavir- 800 mg + Cobicistat-1 50 mg + Emtricitabine- 200 mg + TAF-10 mg

Reference Brands: Symtuza(Eu & US)

Category: Anti Viral

Darunavir, cobicistat, emtricitabine and tenofovir alafenamide (800/150/200/10 mg) single-tablet HIV-1 regimen. For importers, distributors, HIV clinics and hospital pharmacies needing a once-daily boosted protease inhibitor combination.

Product Description:

This tablet joins a boosted protease inhibitor and a nucleoside backbone as one complete daily regimen for HIV-1. Darunavir 800 mg blocks the viral protease, so new virus particles cannot mature. Cobicistat 150 mg, a CYP3A inhibitor without antiviral action, boosts darunavir enough for once-daily dosing. Emtricitabine 200 mg and tenofovir alafenamide 10 mg block reverse transcriptase. Boosted darunavir has a high genetic barrier to resistance. The pack data print cobicistat as 1 50 mg; the correct figure is 150 mg.

It is used in adults and adolescents from 12 years weighing at least 40 kg, to start treatment or to switch while virologically suppressed, where no darunavir resistance is known. It is taken once daily with food. Darunavir contains a sulphonamide group, so caution is needed in sulphonamide allergy, and severe skin reactions and hepatitis are labelled risks. As with other cobicistat products the interaction list is wide. Stopping can trigger a hepatitis B flare in co-infected patients. Cobicistat-boosted darunavir is not recommended in pregnancy because exposure falls.

Sourcing notes. The tablet is prescription-only and registered nationally, and many markets still hold patent or data protection on it, so check the legal position before a generic filing. Generic dossiers need bioequivalence data for all four actives. Supply comes in HDPE bottles with a desiccant; tablets stay in the original bottle, tightly closed, at room temperature. Ask for the batch CoA, GMP certificate and CoPP, with stability covering zone IVb. Give bottle count, label languages and the age and weight wording you need in the leaflet.