ERLEADA (apalutamide) 60mg
Product Overview
| Generic Name | ERLEADA (apalutamide) 60mg |
| Brand Name(s) | ERLEADA® |
| Category | Antineoplastic / Cancer |
| Form | 28, Film-coated oral tablets |
| Strength | 60 mg oral tablets |
| Therapeutic Class | Androgen receptor inhibitor / anti-androgen |
| ATC Code | L02BB05 |
Manufacturing & Regulatory
| Manufacturer | Janssen |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.6350.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
Logistics & Export
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Manufacturer provides COA |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | CTD available to regulators; summary available to qualified partners |
Special Notes
EARLEADA (apalutamide) is an oral androgen receptor inhibitor used in adult men with non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer, generally with ongoing androgen-deprivation therapy unless the patient has had bilateral orchiectomy.