Abiraterone Acetate 250 mg
| Product Overview | |
| Generic Name | Abiraterone Acetate 250 mg |
| Brand Name(s) | ZYTIGA® |
| Product Type | Originator Brand |
| Form | 120 Oral Tablets per bottle |
| Strength | 250 mg |
| Therapeutic Class | Endocrine therapy; androgen biosynthesis inhibitor; CYP17 inhibitor. |
| ATC Code | L02BX03 |
| Manufacturing & Regulatory | |
| Manufacturer | Janssen / Johnson & Johnson / Cipla |
| Country | Italy, India, Canada, USA |
| GMP Compliance | W.H.O. |
| DMF/CEP | Type II: API DMFs |
| COFEPRIS | 010.000.5657.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 bottles |
| Shelf Life | 24 Months |
| Storage | store at 20°C to 25°C, |
| Incoterms | Ex-Works, 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—lot-specific Certificate of Analysis |
| SDS | Upon Request |
| CTD Summary | Not publicly available as parallel traded molecule |
Description
Indications & Usage: Treats prostate cancer advanced metastatic, bottle contains 120 oral tablets