Medicine
Cystaran 6.5 mg/mL ophthalmic solution
Cystaran 6.5 mg/mL ophthalmic solution is a prescription medicine containing Cysteamine for ophthalmic use, marketed by Leadiant Biosciences, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store unopened bottle in freezer at -25°C to -15°C (-13°F to 5°F) in the…
Key facts
- Active ingredient (INN)
- Cysteamine
- Brand
- Cystaran
- Strength
- 6.5 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 15 mL
- Marketing authorisation holder
- Leadiant Biosciences
- Manufacturer
- Leadiant Biosciences
- Origin register
- US FDA, United States
- Storage
- Store unopened bottle in freezer at -25°C to -15°C (-13°F to 5°F) in the original packaging including unopened foil. The thawed bottle does not require refrigeration between use. Store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AA04 Mercaptamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 December 2012
- Identifiers
- RxCUI 1313780, 1313785DailyMed set ID b98ee838-ed23-42a9-93b5-72579e490fbaNDC 54482-035, 54482-020Application NDA200740
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 15 mL in 1 bottle | 54482-020-02 | Leadiant Biosciences | 25 February 2022 |
| 15 mL in 1 bottle | 54482-035-02 | Leadiant Biosciences | 25 April 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 August 1994 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Cysteamine
Clinical summary
Cysteamine is a cystine depleting agent indicated for the management of nephropathic cystinosis in children and adults. It is available as ophthalmic solution, capsules and delayed-release capsules for oral use. MedsAcross supplies Cysteamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about CysteamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cystagon prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Cystaran 6.5 mg/mL ophthalmic solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.