ZYTIGA® (abiraterone) 500mg
Product Overview
| Generic Name | ZYTIGA® (abiraterone) 500mg |
| Brand Name(s) | Zytiga® |
| Category | Antineoplastic / Cancer |
| Form | Oral Tablet, Bottle of 60 tablets |
| Strength | 500mg |
| Therapeutic Class | Cancer, Hormone antagonists and related agents |
| ATC Code | L02BX03 |
Manufacturing & Regulatory
| Manufacturer | Janssen-Cilag International |
| GMP Compliance | W.H.O. |
| DMF/CEP | Type II: API DMFs |
| COFEPRIS | 010.000.6211.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | 10 bottles |
| Shelf Life | 3 years |
| Storage | Store below 30°C Protect from moisture and light. Do not refrigerate or freeze. |
| Incoterms | Ex-Works Mexico, 30049099 |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes—lot-specific Certificate of Analysis |
| GMP Certificate (PDF) | Yes |
| SDS-Safety Data Sheet (PDF) | Upon Request |
| CTD Summary (PDF) | Not publicly available |
Special Notes
Indications & Usage: Treats prostate cancer advanced metastatic.
INN: Abiraterone Acetate
- Strength: 500 mg
- Dosage Form: Tablet
- Presentation: Box of 60 tablets
- CNIS/Clave: 010.000.6211.00
- Product Type: Generic procurement presentation
- Therapeutic Class: Androgen Biosynthesis Inhibitor (CYP17 inhibitor)
- ATC Code: L02BX03