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Manufacturer / Innovator:
USA
Regulatory Approval:
N/A
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Zepzelca (lurbinectedin) is approved by the FDA for two indications in extensive-stage small cell lung cancer (ES-SCLC): in combination with atezolizumab, for maintenance treatment of adults whose disease has not progressed after first-line platinum-based induction chemotherapy plus atezolizumab; and as a single agent for adults with metastatic SCLC that has progressed on or after platinum-based chemotherapy.
Zepzelca binds to DNA and interferes with active gene transcription, disrupting the growth and division of cancer cells. It is derived from a marine-source-inspired synthetic compound and has demonstrated activity against small cell lung cancer, a disease type known for aggressive growth and treatment resistance.
Zepzelca is used both as maintenance therapy following successful first-line treatment and as a later-line therapy for SCLC patients who have progressed after platinum-based chemotherapy, offering treatment options at two different points in the disease course.
The recommended dose of Zepzelca is 3.2 mg/m² administered as an intravenous infusion over 60 minutes, every 21 days, until disease progression or unacceptable toxicity.
Zepzelca does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Severe myelosuppression, including neutropenia, thrombocytopenia, and anemia, is common. Complete blood counts should be monitored before each dose and as clinically indicated.
Liver function tests should be monitored before each dose, as liver enzyme elevations have been reported.
Zepzelca is a hazardous drug, and extravasation can cause tissue necrosis. The infusion site should be monitored closely, and applicable special handling and disposal procedures should be followed.
Cases of rhabdomyolysis have been reported. Zepzelca may also cause fetal harm; effective contraception should be used during treatment and for a period after the final dose.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Zepzelca is marketed by Jazz Pharmaceuticals, with the molecule originally developed by PharmaMar. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating oncologist confirming SCLC diagnosis, stage, and prior treatment history. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for extensive-stage small cell lung cancer, Zepzelca is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.
NPP sources Zepzelca directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Zepzelca requires refrigerated storage at 2°C to 8°C and is handled as a hazardous drug requiring special precautions. NPP maintains a continuous, monitored cold chain throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile cold-chain logistics to the patient's city.
Patients across India can access Zepzelca through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support oncology care coordination and documentation for Zepzelca access.
Delhi's major hospitals assist patients with prescription support and documentation for Zepzelca.
Bangalore's specialist network offers access coordination for eligible small cell lung cancer patients seeking Zepzelca.
Chennai-based oncology specialists coordinate Zepzelca access alongside comprehensive lung cancer care.
Hyderabad's care institutions support patients pursuing Zepzelca therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Zepzelca.
Pune-based specialists assist with prescription support and Zepzelca treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Zepzelca.
Kochi's specialist units assist patients with the documentation needed for Zepzelca access.
Chandigarh's care centers support Zepzelca treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Zepzelca access process.
Lucknow-based centers assist patients pursuing Zepzelca therapy.
Bhubaneswar's institutions support access to Zepzelca for eligible patients.
Guwahati's specialists help coordinate Zepzelca access for patients across the Northeast.
Patients in other cities across India can also access Zepzelca through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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