Gonadotropin Releasing Hormone Receptor Antagonist
Where is Ganirelix made?
10 companies sell it under their own name. Their labels name 5 factories in India, China and the United States.
India 2China 2United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amphastar Pharmaceuticals, Inc.250 ug per 0.5 mL · NDC 0548-5001 | Amphastar Pharmaceuticals, Inc.Makes it and tests it | Rancho Cucamonga, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| Fresenius Kabi USA, LLC250 ug per 0.5 mL · NDC 65219-028 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Gland Pharma Limited250 ug per 0.5 mL · NDC 68083-472 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Lupin Pharmaceuticals, Inc.250 ug per 0.5 mL · NDC 70748-274 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilySep 2025 |
| Meitheal Pharmaceuticals Inc.250 ug per 0.5 mL · NDC 71288-554 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Mullan Pharmaceutical Inc.250 ug per 0.5 mL · NDC 83301-0082 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Qilu Pharmaceutical Co., Ltd.250 ug per 0.5 mL · NDC 67184-0574 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it and tests it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Xiromed, LLC.250 ug per 0.5 mL · NDC 70700-327 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Ferring Pharmaceuticals Inc.250 ug per 0.5 mL · NDC 55566-1010 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Ganirelix Acetate250 ug per 0.5 mL · NDC 78206-138 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Nov 13, 2025 · Class II · Lupin Pharmaceuticals Inc.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. - Apr 19, 2023 · Class II · Sun Pharmaceutical Industries Ltd.
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.