RANK Ligand Inhibitor
Where is Denosumab made?
10 companies sell it under their own name. Their labels name 3 factories in India, South Korea and China.
India 1South Korea 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biocon Biologics Inc. Aukelso, Bosaya60 mg per 1 mL, 120 mg per 1.7 mL · NDC 83257-030, 83257-029 | Biocon Biologics LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyJul 2024 |
| Cordavis Limited Ospomyv60 mg per 1 mL · NDC 83457-012 | Samsung Biologics Co., Ltd.Makes the active ingredient | Incheon, South Korea | Problems found, fixed voluntarilySep 2023 |
| Organon LLC Bilprevda, Bildyos60 mg per 1 mL, 120 mg per 1.7 mL · NDC 78206-195, 78206-193 | Shanghai Henlius Biologics Co., Ltd.Makes it, makes the active ingredient, tests it, packages it and labels it | Shanghai, China | Not inspected on record |
| Accord BioPharma Inc. Osvyrti, Jubereq60 mg per 1 mL, 70 mg per 1 mL · NDC 69448-021, 69448-022 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amgen Inc Xgeva, Prolia60 mg per 1 mL, 120 mg per 1.7 mL · NDC 55513-730, 55513-710 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals LLC Boncresa, Oziltus60 mg per 1 mL, 70 mg per 1 mL · NDC 70121-2702, 70121-2701 | The label doesn't name the factory. Plants this company names for other drugs | ||
| CELLTRION USA, Inc. Osenvelt, Denosumab-BMWO, Stoboclo60 mg per 1 mL, 120 mg per 1.7 mL · NDC 72606-038, 72606-059, 72606-037 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fresenius Kabi USA, LLC Conexxence, Bomyntra60 mg per 1 mL, 70 mg per 1 mL · NDC 65219-668, 65219-672, 65219-670 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc. Xtrenbo, Enoby60 mg per 1 mL, 120 mg per 1.7 mL · NDC 0143-9166, 0143-9165 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Wyost, Jubbonti60 mg per 1 mL, 120 mg per 1.7 mL · NDC 61314-228, 61314-240 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Apr 21, 2025 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations; potential temperature excursions due to transit delays - Sep 17, 2013 · Class II · Amgen, Inc.
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.