Leuprolide Acetate Depot 22.5mg
| Product Overview | |
| Generic Name | Leuprolide Acetate Depot 22.5mg |
| Brand Name(s) | Lupron Depot®, Lorelin® |
| Product Type | Generic |
| Form | Vial, Lyophilized microsphere powder + diluent for depot suspension injection. |
| Strength | 22.25 mg |
| Therapeutic Class | Gonadotropin-releasing hormone agonist; LHRH/GnRH agonist |
| ATC Code | L02AE02 |
| Manufacturing & Regulatory | |
| Manufacturer | AbbVie, Cipla |
| Country | USA, Canada, India |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.5435.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW 30049049 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
This is the generic version of Leuprorelina acetate in 22.5mg per injectable vial.
Leuprolide/leuprorelin acetate depot is a long-acting GnRH agonist that initially stimulates and then suppresses pituitary LH/FSH release, reducing testosterone in men and estrogen in women. It is used for advanced prostate cancer, endometriosis, uterine fibroids, and in pediatric formulations for central precocious puberty; the exact approved indication depends on strength, formulation, route, and jurisdiction.
