NDC 59676-800

Symtuza 4 ingredients tablet, film coated

On the label: Janssen Products LP.

Spain: 2Canada: 2Ireland: 2United States: 1Germany: 1Italy: 1Belgium: 1China: 1South Korea: 1

Where it's made

FactoryWhereRoleLast FDA inspection
AMPAC Fine Chemicals LLCRancho Cordova, CA, United StatesMakes the active ingredient No problems foundSep 10, 2025 · 9 inspections, 1 with FDA action
Esteve Quimica, S.A.Celra, SpainMakes the active ingredient Problems found, fixed voluntarilySep 18, 2025 · 6 inspections
Evonik Operations GmbHDossenheim, GermanyMakes the active ingredient No problems foundSep 15, 2023 · 4 inspections
Gilead Alberta ULCEdmonton, CanadaMakes the active ingredient No problems foundMay 12, 2023 · 6 inspections
Janssen Cilag SpABorgo San Michele, ItalyMakes it and packages it Problems found, fixed voluntarilySep 27, 2024 · 6 inspections
Janssen Pharmaceutica NVGeel, BelgiumMakes it Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections
Janssen Pharmaceutical Sciences Unlimited CompanyCo Cork, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 27, 2023 · 5 inspections
Patheon Inc.Mississauga, CanadaMakes it and tests it Problems found, fixed voluntarilyFeb 24, 2023 · 7 inspections
Porton Pharma Solutions LtdChongqing, ChinaMakes the active ingredient No problems foundMar 29, 2024 · 3 inspections
Thermo Fisher Scientific Cork LimitedCarrigaline, IrelandMakes the active ingredient Problems found, fixed voluntarilySep 7, 2022 · 6 inspections, 1 with FDA action
Union Quimico Farmaceutica SaSant Celoni, SpainMakes the active ingredient Problems found, fixed voluntarilyJul 7, 2022 · 4 inspections
Yuhan Chemical Inc.Ansan-si, South KoreaMakes the active ingredient Problems found, fixed voluntarilyFeb 28, 2025 · 6 inspections
Janssen Ortho LLCGurabo, PR, United StatesPackages it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections
Janssen Pharmaceuticals Inc.Raritan, NJ, United StatesTests it No problems foundJun 17, 2022 · 8 inspections

Product details

Generic drug
Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide: every company that makes it
Form
tablet, film coated, oral
Strength
4 ingredients
Approval
NDA NDA210455
On the market since
Jul 17, 2018
Package NDCs
59676-800-30 59676-800-99
Official label
DailyMed (National Library of Medicine), updated Apr 17, 2026

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