Carboplatin 450mg
Product Overview
| Generic Name | Carboplatin 450mg |
| Brand Name(s) | Paraplatin, CARBOplatin, Novaplus |
| Category | Antineoplastic / Cancer |
| Form | Intravenous injection – sterile aqueous solution, multi-dose vial |
| Strength | 450 mg /45 mL |
| Therapeutic Class | Platinum-based antineoplastic alkylating agent |
| ATC Code | L01XA02 |
Manufacturing & Regulatory
| Manufacturer | Bristol-Myers Squibb, Pfizer (Paraplatin), Teva, Celon Labs, Fresenius Kabi, Rapid Medico, Onco India, Celon |
| GMP Compliance | EU/WHO/US FDA/CDSCO |
| DMF/CEP | Type II/III DMFs requires direct inquiry |
| COFEPRIS | 010.000.6290.00 |
| Free Sale Certificate | Yes, Available upon request from GMP‑certified manufacturers |
Logistics & Export
| MOQ | 25 units |
| Shelf Life | 36 months |
| Storage | 15–25 °C; protect from light; amber vials; store in cool dry place |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes, upon request |
| SDS-Safety Data Sheet (PDF) | standard for cytotoxic injectable drugs |
| CTD Summary (PDF) | CTD summary/ANDA dossier available upon purchase commitment and NDA/fee |
Special Notes
Indications & Usage: Carboplatin is a platinum‑based alkylating chemotherapy agent for ovarian, lung, head/neck, bladder, and germ‑cell tumors. Dosage is calculated by Calvert formula using AUC and GFR; commonly 450 mg IV infusion every 3–4 weeks. Lower nephrotoxicity than cisplatin but notable myelosuppression; hydration and blood‑count monitoring required.