Protease Inhibitor
Where is Darunavir made?
11 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 19 factories in India, the United States, Belgium, Ireland, Switzerland, Italy and 1 other.
India 10United States 2Belgium 2Ireland 2Switzerland 1Italy 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Products LP Prezista75 mg, 100 mg per 1 mL, 150 mg, 600 mg, 800 mg · NDC 59676-565, 59676-564, 59676-562 +2 | Cilag AGMakes the active ingredient | Schaffhausen, Switzerland | No problems foundNov 2025 |
| Janssen Cilag SpAMakes it and tests it | Borgo San Michele, Italy | Problems found, fixed voluntarilySep 2024 | |
| Janssen Ortho LLCMakes it and tests it | Gurabo, PR, United States | Problems found, fixed voluntarilyMar 2023 | |
| Janssen Pharmaceutica NVMakes it and tests it | Beerse, Belgium | Problems found, fixed voluntarilySep 2025 | |
| Janssen Pharmaceutica NVMakes the active ingredient | Geel, Belgium | Problems found, fixed voluntarilyMar 2024 | |
| Janssen Pharmaceutical Sciences Unlimited CompanyMakes the active ingredient | Co Cork, Ireland | Problems found, fixed voluntarilyOct 2023 | |
| Porton Pharma Solutions LtdMakes the active ingredient | Chongqing, China | No problems foundMar 2024 | |
| Thermo Fisher Scientific Cork LimitedMakes the active ingredient | Carrigaline, Ireland | Problems found, fixed voluntarilySep 2022 | |
| Cipla USA., Inc.600 mg, 800 mg · NDC 69097-248, 69097-244 | Cipla LimitedMakes it, tests it, packages it and labels it | Raigad, India | Problems found, fixed voluntarilyApr 2024 |
| Cipla LimitedMakes the active ingredient | Pune, India | Problems found, fixed voluntarilyMay 2024 | |
| InvaGen Pharmaceuticals, IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyJul 2026 | |
| Camber Pharmaceuticals Inc.400 mg, 600 mg, 800 mg · NDC 31722-567, 31722-568, 31722-088 +1 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Exelan Pharmaceuticals, Inc.600 mg, 800 mg · NDC 76282-737, 76282-738 | Cipla LimitedMakes the active ingredient | Pune, India | Problems found, fixed voluntarilyMay 2024 |
| InvaGen Pharmaceuticals, IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyJul 2026 | |
| Amneal Pharmaceuticals600 mg, 800 mg · NDC 60219-1144, 60219-1145 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited600 mg, 800 mg · NDC 59651-085, 59651-086 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Cadila Healthcare Limited600 mg, 800 mg · NDC 70771-1745, 70771-1746 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Dr. Reddy's Laboratories Inc.600 mg, 800 mg · NDC 43598-704, 43598-705 | Laurus Labs LimitedMakes it and tests it | Anakapalli, India | Problems found, fixed voluntarilyFeb 2023 |
| Lupin Pharmaceuticals, Inc.600 mg, 800 mg · NDC 68180-345, 68180-346 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Novadoz Pharmaceuticals LLC600 mg, 800 mg · NDC 72205-184, 72205-185 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Viona Pharmaceuticals Inc.600 mg, 800 mg · NDC 72578-147, 72578-148 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
Repackaged by
These companies buy Darunavir in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- American Health Packaging:
60687-808,60687-819 - Bryant Ranch Prepack:
63629-5686,71335-2611 - NuCare Pharmaceuticals.Inc.:
68071-3910 - Physicians Total Care, Inc.:
54868-5969,54868-6369 - State of Florida DOH Central Pharmacy:
53808-0672,53808-0773