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Cystagon

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Cystagon

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Cystagon
Generic Name (API): Cysteamine bitartrate
Dosage Form & Strength: 50 mg, 150 mg
Route: Oral
Drug Class: Cystine-depleting agent

Manufacturer / Innovator:

France

Regulatory Approval:

  • US FDA
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  • 100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.

    100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.

  • Medicines sourced from authorized manufacturers with full batch traceability

    Medicines sourced from authorized manufacturers with full batch traceability.

  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

    EU-GDP compliant warehousing for secure, quality-controlled global distribution.

  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

GDP Compliant
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What Is Cystagon Used For?

Cystagon (cysteamine bitartrate) is a cystine-depleting agent that lowers the cystine content of cells. It is indicated for the treatment of:

  • Nephropathic cystinosis, an inherited defect of lysosomal transport, in children and adults

Cystagon is a prescription medicine and must be used under the supervision of a metabolic or renal specialist, with regular monitoring of white blood cell cystine levels.

Recommended Dosage

  • New patients are started on 1/4 to 1/6 of the maintenance dose, gradually increased over 4 to 6 weeks to reduce intolerance
  • Maintenance dose in children up to 12 years is 1.30 g/m²/day of free base, given in four divided doses, and may be increased up to a maximum of 1.95 g/m²/day to achieve therapeutic cystine levels

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Cystagon Warnings and Precautions

  • Teratogenic and fetotoxic effects: Cysteamine bitartrate has been shown to be teratogenic and fetotoxic in animal studies, with findings including cleft palate, kyphosis, ventricular septal defects, microcephaly, and exencephaly.
  • Skin and bone monitoring: Physicians should routinely monitor the skin and bones of patients receiving Cystagon.
  • CNS effects: Seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine and may require dose adjustment.
  • Gastrointestinal tolerance: Vomiting, anorexia, and gastrointestinal upset occur more frequently at higher doses; gradual titration helps reduce intolerance.

How to Access Cystagon in India: A 6-Step Process

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.

Documentation & Availability

What documents are required to import Cystagon to India?

Cystagon (cysteamine bitartrate) capsules 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:

  • A valid prescription from a qualified metabolic or renal specialist
  • The patient's diagnostic reports, including confirmation of nephropathic cystinosis and white blood cell cystine levels
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is Cystagon available in India?

Cystagon (cysteamine bitartrate capsules) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Cystagon is not commercially marketed in India.

However, patients in India can legally access Cystagon through the Named Patient Program (NPP) — an import provision that allows patients to receive medicines approved in other countries but not yet marketed in India, under a doctor's prescription and proper regulatory documentation.

Cystagon received US FDA approval for the treatment of nephropathic cystinosis, ensuring full transparency throughout the process.

Cystagon can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others.

Sourcing & Delivery of Cystagon

Cystagon is sourced directly from authorized channels in the country of origin and shipped to India under GDP-compliant logistics to preserve product integrity from dispatch to delivery.

  • Storage maintained at 15°C to 30°C throughout transit
  • Real-time shipment tracking and delivery updates
  • Delivery coordinated directly with the patient, family, or treating hospital

Availability of Cystagon Across Major Cities in India

Named Patient Program supports access to Cystagon for patients with nephropathic cystinosis across major cities in India, coordinating documentation, sourcing, and delivery with treating specialists.

Mumbai

Patients in Mumbai can access Cystagon through NPP with support from treating metabolic and renal specialists.

Delhi

In Delhi, NPP coordinates with hospitals and specialty renal and metabolic clinics to facilitate timely access to Cystagon.

Bangalore

Bangalore's genetics and metabolic disorder centers work with NPP to support patients requiring Cystagon.

Chennai

Patients in Chennai can access Cystagon through NPP, with coordination between treating doctors and the program's regulatory and logistics team.

Hyderabad

Hyderabad's metabolic and genetic testing centers support diagnosis and access coordination for Cystagon through NPP.

Kolkata

NPP facilitates access to Cystagon for patients in Kolkata under the guidance of treating specialists.

Pune

Patients in Pune can access Cystagon through NPP with prescription-based coordination and delivery support.

Ahmedabad

NPP supports access to Cystagon for patients in Ahmedabad, working directly with treating specialists.

Kochi

Patients in Kochi and across Kerala can access Cystagon through NPP's regulated import pathway.

Chandigarh

NPP coordinates access to Cystagon for patients in Chandigarh and the surrounding region.

Jaipur

Patients in Jaipur can access Cystagon through NPP with support from treating specialists.

Lucknow

NPP facilitates access to Cystagon for patients in Lucknow and across Uttar Pradesh.

Bhubaneswar

Patients in Bhubaneswar can access Cystagon through NPP's coordinated import and delivery process.

Guwahati

NPP supports access to Cystagon for patients in Guwahati and across the Northeast region.

NPP also supports access for patients in other Indian cities not listed above — contact the team to check availability and timelines for your location.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 08 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 08 September 2026

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