Pan Am Farma

Carboplatin 450mg

Product Overview
Generic NameCarboplatin 450mg
Brand Name(s)Paraplatin, CARBOplatin, Novaplus
FormIntravenous injection – sterile aqueous solution, multi-dose vial
Strength450 mg /45 mL
Therapeutic ClassPlatinum-based antineoplastic alkylating agent
ATC CodeL01XA02
Manufacturing & Regulatory
ManufacturerBristol-Myers Squibb, Pfizer (Paraplatin), Teva, Celon Labs, Fresenius Kabi, Rapid Medico, Onco India, Celon
CountryUSA, India, Israel
GMP ComplianceEU/WHO/US FDA/CDSCO
DMF/CEPType II/III DMFs requires direct inquiry
COFEPRIS010.000.6290.00
Free Sale CertificateYes, Available upon request from GMP‑certified manufacturers
Logistics & Export
MOQ25 units
Shelf Life36 months
Storage15–25 °C; protect from light; amber vials; store in cool dry place
IncotermsEx-Works Mexico
Lead Time7 to 10 Days
Documentation
Certificate of Analysis (COA)Yes, upon request
SDSstandard for cytotoxic injectable drugs
CTD SummaryCTD summary/ANDA dossier available upon purchase commitment and NDA/fee

Description

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.
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