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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Qalsody on our secure patient portal to submit your prescription, upload documents and track your approval status.
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:
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Over a decade of trusted expertise in Named Patient Access to innovative and life-saving medicines.
100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.
Medicines sourced from authorized manufacturers with full batch traceability.
EU-GDP compliant warehousing for secure, quality-controlled global distribution.
Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.
Qalsody (tofersen) is an antisense oligonucleotide approved by the FDA under accelerated approval for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
Qalsody works by binding to SOD1 mRNA, reducing the production of SOD1 protein. In patients with SOD1-ALS, mutant SOD1 protein is believed to contribute to motor neuron degeneration; by lowering SOD1 protein levels, Qalsody aims to slow disease progression.
Qalsody is intended specifically for the small subset of ALS patients confirmed to carry an SOD1 gene mutation through genetic testing. It is not intended for ALS patients without this specific mutation.
Qalsody is given as an intrathecal injection, with three loading doses of 100 mg administered at 14-day intervals, followed by a maintenance dose of 100 mg every 28 days.
Qalsody does not carry a formal FDA boxed warning. However, patients and caregivers should be aware of the following important safety information.
Serious neurological events, including myelitis and radiculitis, have been reported with Qalsody. Patients should be monitored for new or worsening neurological symptoms.
Cases of papilledema and elevated intracranial pressure have occurred, requiring diagnostic evaluation and appropriate management if symptoms such as headache or visual changes develop.
Aseptic (chemical) meningitis has been reported following intrathecal administration. Patients should be monitored for symptoms such as headache, neck stiffness, or fever following each dose.
As Qalsody requires intrathecal administration via lumbar puncture, standard procedural risks associated with this method of delivery apply.
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.
Qalsody is manufactured and marketed by Biogen. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating neurologist confirming ALS diagnosis and SOD1 gene mutation testing results. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for SOD1-ALS, Qalsody is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.
NPP sources Qalsody 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.
Qalsody requires refrigerated storage at 2°C to 8°C and must not be frozen. 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 Qalsody through NPP's regulated import pathway, with neurology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support ALS care coordination and documentation for Qalsody access.
Delhi's major hospitals assist patients with prescription support and documentation for Qalsody.
Bangalore's specialist network offers access coordination for eligible SOD1-ALS patients seeking Qalsody.
Chennai-based neurology specialists coordinate Qalsody access alongside comprehensive ALS care.
Hyderabad's care institutions support patients pursuing Qalsody therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Qalsody.
Pune-based specialists assist with prescription support and Qalsody treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Qalsody.
Kochi's specialist units assist patients with the documentation needed for Qalsody access.
Chandigarh's care centers support Qalsody treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Qalsody access process.
Lucknow-based centers assist patients pursuing Qalsody therapy.
Bhubaneswar's institutions support access to Qalsody for eligible patients.
Guwahati's specialists help coordinate Qalsody access for patients across the Northeast.
Patients in other cities across India can also access Qalsody through NPP's nationwide coordination network.
Last Updated: 15 September 2026
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