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Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
USA
Regulatory Approval:
N/A
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Pemazyre (pemigatinib) is a kinase inhibitor approved by the FDA under accelerated approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement, as well as for relapsed or refractory myeloid/lymphoid neoplasms with an FGFR1 rearrangement.
Pemazyre selectively inhibits fibroblast growth factor receptors (FGFR1, 2, and 3), which are involved in abnormal cell growth signaling in tumors harboring FGFR gene alterations, helping to slow or stop cancer cell proliferation.
Pemazyre is intended for patients with cholangiocarcinoma confirmed to carry an FGFR2 fusion or rearrangement through an FDA-approved test, or patients with myeloid/lymphoid neoplasms carrying an FGFR1 rearrangement.
For cholangiocarcinoma, the recommended dose is 13.5 mg orally once daily for 14 days followed by 7 days off, in 21-day cycles. For FGFR1-rearranged neoplasms, the dose is 13.5 mg orally once daily continuously.
Pemazyre does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Retinal pigment epithelial detachment and other eye disorders have been reported. Periodic ophthalmic examinations are recommended before and during treatment.
Elevated phosphate levels are common and can lead to soft-tissue mineralization, including calciphylaxis in rare cases. Phosphate levels should be monitored regularly during treatment.
Pemazyre may cause fetal harm. Effective contraception should be used during treatment and for a period after the final dose, as advised by the treating physician.
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.
Pemazyre is manufactured and marketed by Incyte Corporation. 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 diagnosis and FGFR fusion/rearrangement testing results. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for FGFR-altered cholangiocarcinoma and myeloid/lymphoid neoplasms, Pemazyre is sourced through authorized channels and imported under GDP-compliant logistics to preserve product quality throughout transit.
NPP sources Pemazyre 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.
Pemazyre should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, and this condition is maintained 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 logistics to the patient's city.
Patients across India can access Pemazyre 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 Pemazyre access.
Delhi's major hospitals assist patients with prescription support and documentation for Pemazyre.
Bangalore's specialist network offers access coordination for eligible cholangiocarcinoma patients seeking Pemazyre.
Chennai-based oncology specialists coordinate Pemazyre access alongside comprehensive cancer care.
Hyderabad's care institutions support patients pursuing Pemazyre therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Pemazyre.
Pune-based specialists assist with prescription support and Pemazyre treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Pemazyre.
Kochi's specialist units assist patients with the documentation needed for Pemazyre access.
Chandigarh's care centers support Pemazyre treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Pemazyre access process.
Lucknow-based centers assist patients pursuing Pemazyre therapy.
Bhubaneswar's institutions support access to Pemazyre for eligible patients.
Guwahati's specialists help coordinate Pemazyre access for patients across the Northeast.
Patients in other cities across India can also access Pemazyre 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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