Afatinib 40mg Tab
| Product Overview | |
| Generic Name | Afatinib 40mg Tab |
| Brand Name(s) | Gilotrif®, Giotrif®, Afanat |
| Form | 30 film-coated oral tablets |
| Strength | 40 mg |
| Therapeutic Class | ErbB-family blocker; irreversible EGFR/HER2 tyrosine kinase inhibitor; targeted anticancer therapy |
| ATC Code | L01EB03 |
| Manufacturing & Regulatory | |
| Manufacturer | Boehringer Ingelheim, Natco Pharma |
| Country | EU, India, Mexico |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II DMF |
| COFEPRIS | none for 20mg |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 36 months |
| Storage | store in original package to protect from moisture and light |
| Incoterms | Exw, HS/HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | GHS-Compliant |
| CTD Summary | Not publicly available as a complete CTD |
Description
Afatinib is an oral irreversible ErbB-family tyrosine kinase inhibitor used in specialist oncology for adult patients with locally advanced or metastatic non-small cell lung cancer. It is indicated particularly for EGFR mutation-positive NSCLC in EGFR TKI-naïve patients, and in certain jurisdictions for locally advanced or metastatic squamous NSCLC progressing during or after platinum-based chemotherapy.
