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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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Romvimza (vimseltinib) is a kinase inhibitor approved by the FDA for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection would potentially cause worsening functional limitation or severe morbidity.
Romvimza inhibits colony-stimulating factor 1 receptor (CSF1R), a protein that is overactive in TGCT due to a genetic translocation, helping to reduce the abnormal proliferation of tumor cells characteristic of this condition.
Romvimza is intended for TGCT patients whose tumor is causing significant symptoms and where surgery is not a good option due to the risk of worsening function or severe morbidity.
The recommended dose of Romvimza is 30 mg taken orally twice weekly, with a minimum of 72 hours between doses.
Romvimza does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Liver function should be monitored during treatment, as liver enzyme elevations have been observed, though serious or fatal liver injury was not commonly seen in clinical trials.
Romvimza may cause fetal harm. Effective contraception should be used during treatment.
The 14 mg and 20 mg capsules contain FD&C Yellow dyes, which may cause allergic-type reactions, including asthma, in susceptible individuals.
Increases in serum creatinine have been observed without evidence of true renal impairment; this should be considered when interpreting kidney function tests during treatment.
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.
Romvimza is manufactured and marketed by Deciphera Pharmaceuticals, LLC, an ONO Pharmaceutical company. 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 TGCT diagnosis and clinical assessment of surgical candidacy. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for symptomatic TGCT, Romvimza is sourced through authorized channels and imported under GDP-compliant logistics to preserve product quality throughout transit.
NPP sources Romvimza 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.
Romvimza 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 Romvimza 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 Romvimza access.
Delhi's major hospitals assist patients with prescription support and documentation for Romvimza.
Bangalore's specialist network offers access coordination for eligible TGCT patients seeking Romvimza.
Chennai-based oncology specialists coordinate Romvimza access alongside comprehensive TGCT care.
Hyderabad's care institutions support patients pursuing Romvimza therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Romvimza.
Pune-based specialists assist with prescription support and Romvimza treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Romvimza.
Kochi's specialist units assist patients with the documentation needed for Romvimza access.
Chandigarh's care centers support Romvimza treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Romvimza access process.
Lucknow-based centers assist patients pursuing Romvimza therapy.
Bhubaneswar's institutions support access to Romvimza for eligible patients.
Guwahati's specialists help coordinate Romvimza access for patients across the Northeast.
Patients in other cities across India can also access Romvimza 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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