Gonadotropin Releasing Hormone Receptor Agonist
Where is Leuprolide made?
8 companies sell it under their own name. Their labels name 4 factories in France, Taiwan and Spain.
France 2Taiwan 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Foresee Pharmaceuticals Co., Ltd. Camcevi Etm, Camcevi21 mg per 0.300 g, 42 mg per 1 mL · NDC 72851-100, 72851-042 | Fareva PauMakes it and tests it | Idron, France | Problems found, fixed voluntarilyJan 2025 |
| Pierre Fabre Medicament ProductionMakes it | Aignan, France | Not inspected on record | |
| ScinoPharm Taiwan, Ltd.Makes the active ingredient | Tainan, Taiwan | Serious problems, FDA actionJun 2026 | |
| Accord BioPharma Inc. Camcevi42 mg per 0.37 g · NDC 69448-023, 69448-014 | Fareva PauMakes it and tests it | Idron, France | Problems found, fixed voluntarilyJan 2025 |
| ScinoPharm Taiwan, Ltd.Makes the active ingredient | Tainan, Taiwan | Serious problems, FDA actionJun 2026 | |
| Cipla USA., Inc. Leuprolide Acetate Depot22.5 mg per 2 mL · NDC 69097-909 | GP Pharm S.a.u.Makes it | Sant Quinti De Mediona, Spain | Problems found, fixed voluntarilySep 2023 |
| AbbVie Inc. Lupron Depot-PED, Lupron Depot7.5 mg per 1 mL, 11.25 mg per 1 mL, 11.25 mg per 1.5 mL, 15 mg per 1 mL, 22.5 mg per 1.5 mL, 30 mg per 1.5 mL · NDC 0074-2282, 0074-3663, 0074-3779 +8 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Avyxa Pharma, LLC Lutrate Depot22.5 mg per 2 mL · NDC 83831-134 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.1 mg per 0.2 mL · NDC 42023-259 | The label doesn't name the factory. Plants this company names for other drugs | ||
| TOLMAR Inc. Eligard, Fensolvi7.5 mg per 0.25 mL, 22.5 mg per 0.375 mL, 30 mg per 0.5 mL, 45 mg per 0.375 mL · NDC 62935-223, 62935-227, 62935-303 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Uronova Pharmaceuticals, Inc.7.5 mg per 0.25 mL, 22.5 mg per 0.375 mL, 30 mg per 0.5 mL, 45 mg per 0.375 mL · NDC 85043-025, 85043-030, 85043-045 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Sep 12, 2023 · Class III · Tolmar, Inc.
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. - Mar 10, 2014 · Class II · AbbVie Inc · 4 recall notices
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. - Mar 10, 2014 · Class II · AbbVie Inc
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.