Medicine
Orfadin 5 mg capsule
Orfadin 5 mg capsule is a prescription medicine containing Nitisinone for oral use, marketed by Swedish Orphan Biovitrum AB (publ), 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 refrigerated at 2° to 8°C (36° to 46°F). Oral suspension 4 mg/mL, NDC…
Key facts
- Active ingredient (INN)
- Nitisinone
- Brand
- Orfadin
- Strength
- 5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB (publ)
- Manufacturer
- Swedish Orphan Biovitrum AB (publ)
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2° to 8°C (36° to 46°F). Oral suspension 4 mg/mL, NDC 66658-204-90 Store refrigerated at 2°C to 8°C (36°F to 46°F) prior to first use. Do not freeze. Alternatively, patients/caregivers may store ORFADIN capsules at room temperature up to 25°C (77°F) for up to 45 days. Store upright.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX04 Nitisinone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2016
- Identifiers
- RxCUI 351173, 351174, 351175 +5DailyMed set ID 5d449b73-d503-4132-b978-d890491975dfNDC 66658-105Application NDA021232
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 |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 60 capsule in 1 bottle, plastic | 66658-105-60 | Swedish Orphan Biovitrum AB (Publ) | 1 July 2016 |
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.
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
Alternatives
Other makers and brands of Nitisinone 5 mg capsule.
Other strengths and forms of Nitisinone
Clinical summary
Nitisinone is a 4-hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. MedsAcross supplies Nitisinone 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 NitisinoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Orfadin prescribing information (Swedish Orphan Biovitrum AB (Publ)) · U.S. National Library of Medicine, DailyMed
- Orfadin: European public assessment report (EPAR) · European Medicines Agency
- Nityr: European public assessment report (EPAR) · European Medicines Agency
Need Orfadin 5 mg capsule 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.