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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:
Belgium
Regulatory Approval:
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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.
Translarna (ataluren) was designed to enable ribosomes to read through certain premature stop codons (nonsense mutations) in the dystrophin gene, potentially restoring production of functional dystrophin protein.
Important regulatory update: Translarna has never been approved by the US FDA — in 2017, an FDA advisory committee concluded the evidence supporting its effectiveness was inconclusive. In the EU, Translarna held a conditional marketing authorization from 2014, but following a re-examination of the full clinical data set, the European Commission formally withdrew this authorization on 28 March 2025, after the EMA's human medicines committee (CHMP) concluded that Translarna's effectiveness had not been adequately demonstrated. As of this review, Translarna does not hold marketing authorization in any major regulated market (US or EU). Some countries have allowed continued access on a named-patient or compassionate-use basis under national provisions, independent of the central EU authorization.
Given this regulatory history, any decision to pursue Translarna should be made in close consultation with the treating neurologist, who can discuss the current evidence, the availability of alternative DMD therapies, and whether named-patient access is realistically obtainable for a specific patient.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Step 1 – Search & request your medicine: The patient's treating neurologist submits a request with basic details to initiate the access process, after discussing the current regulatory status and evidence base with the family.
Step 2 – Verification & eligibility review: The team verifies whether Translarna can currently be sourced given its withdrawn EU authorization, and reviews eligibility against regulatory and clinical requirements.
Step 3 – Receive quote & delivery timeline: If sourcing is possible, 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: Given the withdrawn EU authorization, availability cannot be guaranteed for every request — the team will confirm sourcing feasibility before proceeding.
Translarna (ataluren) granules may be imported in the patient's name only, by patients or government hospitals, in line with India's import regulations for unapproved medicines. The following documentation is required:
The order is confirmed only after receipt and verification of a valid prescription and, if applicable, an import permit — and after NPP confirms current sourcing feasibility given Translarna's regulatory status.
Translarna (ataluren granules for oral suspension) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Translarna is not commercially marketed in India, and does not hold marketing authorization in the US (never approved) or the EU (authorization withdrawn March 2025).
Where continued named-patient or compassionate-use access exists in specific countries under national provisions, NPP can explore sourcing options through the Named Patient Program (NPP) pathway, subject to confirmed availability at the time of request.
For patients with Duchenne muscular dystrophy caused by mutations other than nonsense mutations, NPP also facilitates access to exon-skipping therapies including Exondys 51, Amondys 45, and Vyondys 53, depending on the patient's specific gene mutation.
Given Translarna's withdrawn EU marketing authorization, sourcing is confirmed on a case-by-case basis before any order is placed. Where available, it is shipped to India under GDP-compliant logistics to preserve product integrity from dispatch to delivery.
Named Patient Program can explore sourcing options for Translarna for patients with nonsense-mutation Duchenne muscular dystrophy across major cities in India, subject to current availability given its withdrawn EU authorization.
Patients in Mumbai can consult with treating neurologists and contact NPP to explore Translarna sourcing options.
In Delhi, NPP can coordinate with hospitals and specialty neurology clinics to explore access options for Translarna.
Bangalore's neurology and genetics centers can work with NPP to explore Translarna access, subject to availability.
Patients in Chennai can contact NPP, with coordination between treating doctors and the program's regulatory team, to explore options.
Hyderabad's neurology and genetic testing centers can support diagnosis and exploration of access options through NPP.
NPP can explore access options for Translarna for patients in Kolkata under the guidance of treating neurologists.
Patients in Pune can contact NPP to explore Translarna sourcing options, subject to current availability.
NPP can explore options for patients in Ahmedabad, working directly with treating specialists.
Patients in Kochi and across Kerala can contact NPP to explore Translarna access options.
NPP can coordinate exploration of access options for patients in Chandigarh and the surrounding region.
Patients in Jaipur can contact NPP with support from treating neurologists to explore options.
NPP can explore access options for patients in Lucknow and across Uttar Pradesh.
Patients in Bhubaneswar can contact NPP to explore Translarna sourcing options.
NPP can explore access options for patients in Guwahati and across the Northeast region.
NPP also supports patients in other Indian cities not listed above — contact the team to discuss current availability, and to explore alternative DMD therapies such as exon-skipping treatments if applicable to your child's specific mutation.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 09 September 2026
Sources: FDA • CDSCO
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 09 September 2026
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