Bacillus Calmette–Guérin {BCG Live}
| Product Overview | |
| Generic Name | Bacillus Calmette–Guérin {BCG Live} |
| Brand Name(s) | SII-ONCO-BCG / Onco BCG |
| Form | 1/pk 3 vials, lyophilized powder / freeze-dried for suspension |
| Strength | 40 mg |
| Therapeutic Class | Intravesical immunotherapy / immunostimulant |
| ATC Code | L03AX03 |
| Manufacturing & Regulatory | |
| Manufacturer | Serum Institute, Organon-Teknika, Teva |
| Country | India, USA |
| GMP Compliance | WHO-GMP / CPP-supporting GMP certificate |
| DMF/CEP | STN 102821, not as a DMF |
| COFEPRIS | 010.000.5466.00 |
| Free Sale Certificate | Depends on destination, Order size, NDA/KYC |
| Logistics & Export | |
| MOQ | 500 units/Govt Use only |
| Shelf Life | 12 to 18 months |
| Storage | 2–8 °C refrigerated; protect from direct sunlight |
| Incoterms | EXW India |
| Lead Time | 14 to 21 days |
| Documentation | |
| Certificate of Analysis (COA) | batch-specific CoA |
| SDS | biological infectious-risk handling |
| CTD Summary | CTD/regulatory dossier is manufacturer-controlled and proprietary |
Description
Bacillus Calmette–Guérin / BCG for intravesical use is a live attenuated immunotherapy used in selected patients with non-muscle invasive bladder cancer, including carcinoma in situ and Ta/T1 disease after transurethral resection. It is administered directly into the bladder by catheter under specialist supervision and works by stimulating local immune activity against malignant urothelial cells. It requires strict refrigerated handling, biohazard precautions, prescription control, and regulatory review before import or institutional supply
