Product/Composition:- | Cytarabine IV/SQ/Intrathecal Injection |
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Strength:- | 100 mg/mL(IV & SQ); 50 mg/mL(intrathecal use) |
Form:- | Injection |
Reference Brands:- | DepoCyt(US) |
MOQ | As per the manufacturer batch size |
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Cytarabine inhibits DNA synthesis by incorporating into DNA strands, disrupting cell replication. It effectively treats leukemia and lymphoma by targeting rapidly dividing cancer cells. Benefits include rapid tumor reduction, improved remission rates, and enhanced survival, making it a key chemotherapeutic agent in hematologic malignancies.
Cytarabine injection is approved in the US by the FDA and in the EU via EMA for treating leukemia and lymphoma. Regulatory approval requires a comprehensive dossier featuring clinical trial data, manufacturing quality, safety, efficacy, and pharmacovigilance plans. In the US, the FDA reviews detailed submissions, while EMA ensures compliance with regional standards. For expert guidance on dossier preparation, regulatory pathways, and successful market entry, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of cytarabine injection worldwide, supporting optimal patient outcomes and expanded access in oncology treatments.