Orfadin (nitisinone) is an oral 4-hydroxyphenylpyruvate dioxygenase inhibitor for hereditary tyrosinaemia type 1 and, in the EU, alkaptonuria, sold as capsules and an oral suspension and bought by metabolic and paediatric centres.
M Care Exports supplies Orfadin (nitisinone), held by Swedish Orphan Biovitrum (Sobi), together with the other nitisinone brands and generics that regulators list, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Orfadin capsules or the Orfadin oral suspension, send the destination, the strength, the presentation and the quantity, and we quote per destination.
Also marketed as Nityr.
Nitisinone exporter and bulk supplier from India.
"We need a partner for Orfadin" is a typical enquiry from a metabolic centre or a ministry tender desk. Nitisinone is a rare-disease medicine bought in small, repeat volumes, so the quote turns on strength (2, 5, 10 or 20 mg capsule, or the 4 mg/mL suspension), pack, quantity and the registration route in your destination. M Care is a merchant-exporter: we quote the originator and any other nitisinone product your destination registers, and we confirm availability and the import route per enquiry. Orfadin is stored in a refrigerator on the EU and US labels, which affects the freight lane. For other oral specialty lines see our product categories.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
4-hydroxyphenylpyruvate dioxygenase inhibitor, sourced and documented for export.
Nitisinone inhibits 4-hydroxyphenylpyruvate dioxygenase. The EU Orfadin SmPC lists two indications: hereditary tyrosinaemia type 1 (HT-1) in adults and children of any age, together with dietary restriction of tyrosine and phenylalanine, and alkaptonuria (AKU) in adults. The US Orfadin label lists HT-1 only, in adults and children, again with a diet restricted in tyrosine and phenylalanine. Orfadin comes as 2 mg, 5 mg, 10 mg and 20 mg capsules and a 4 mg/mL oral suspension. In the US, Nityr tablets (2, 5 and 10 mg) are labelled for HT-1 and Harliku 2 mg tablets for reduction of urine homogentisic acid in adults with AKU. The EMA lists Nityr (10 mg tablets) as a generic of Orfadin, and its authorisation holder is Cycle Pharmaceuticals (Europe) Ltd. The EMA records Swedish Orphan Biovitrum International AB as the Orfadin authorisation holder, with Orfadin authorised on 21 February 2005.
Active ingredient
Nitisinone. 4-hydroxyphenylpyruvate dioxygenase inhibitor.
Forms and strengths
2 mg hard capsule (Orfadin); 5 mg hard capsule (Orfadin); 10 mg hard capsule (Orfadin); 20 mg hard capsule (Orfadin); 4 mg/mL oral suspension (Orfadin); 10 mg tablet (Nityr); 2 mg tablet (Harliku, US).
Indications
Nitisinone, an oral 4-hydroxyphenylpyruvate dioxygenase inhibitor indicated, with dietary restriction of tyrosine and phenylalanine, for hereditary tyrosinaemia type 1 and, in the EU, for alkaptonuria in adults. Supplied as Sobi's originator Orfadin capsules and oral suspension, with Nityr and Harliku tablets as separate brands and generic nitisinone capsules in the US and UK.
Administration
Oral. Hard capsule and oral suspension.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are metabolic and paediatric hospital pharmacists, ministry of health and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Orfadin 5 mg capsules" or "We need a partner for nitisinone for a metabolic centre". Each destination has its own route: a registered product through the national regulator (for example the Emirates Drug Establishment in the UAE, NAFDAC in Nigeria, the MHRA in the UK), or, where the product is not registered, an import route that depends on that regulator. M Care confirms the route per enquiry and does not assume one.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on nitisinone.
Do not treat the US and EU Orfadin labels as interchangeable. The US label starts HT-1 at 0.5 mg/kg twice daily. The EU SmPC starts at 1 mg/kg a day, usually once daily, split into two doses under 20 kg body weight, with a maximum of 2 mg/kg a day. The EU AKU dose for adults is 10 mg once daily. Both regions pair treatment with a diet restricted in tyrosine and phenylalanine. Orfadin storage is 2 to 8 °C. The US capsule label allows patients to keep capsules at room temperature up to 25 °C for up to 45 days; the EU SmPC allows a single period at up to 25 °C of 2 months (2 mg) or 3 months (5, 10, 20 mg). Build the lane to the stricter standard and leave clinical dosing decisions to the prescriber.
The documentation pack a regulator actually asks for.
Orfadin capsules and suspension are refrigerated products, so a bulk order needs a 2 to 8 °C lane, in-transit logging and a remaining-shelf-life check on arrival. The EU SmPC gives a capsule shelf life of 2 years and a suspension shelf life of 3 years, with a single in-use period of 2 months once the suspension is opened. The US label gives the suspension 60 days at room temperature after opening. The US label names Apotek Produktion & Laboratorier AB in Sweden as manufacturer and Sobi, Inc. as marketer. Storage is product-specific: Nityr and Harliku tablets are stored at 20 to 25 °C per the US labels, the US Par Health generic nitisinone capsule label also gives 20 to 25 °C, and the UK LogixX Pharma nitisinone capsule SmPC says store below 30 °C, so the lane follows the label of the product quoted. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state each source's quality status per line and make no claim for M Care itself beyond merchant-exporter documentation.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside nitisinone.
Rifaximin
Non-absorbable rifamycin antibiotic · traveller's diarrhoea, hepatic encephalopathy
Icatibant
Bradykinin B2 receptor antagonist · acute attacks of hereditary angioedema
Eculizumab biosimilar
C5 complement inhibitor · PNH · aHUS · gMG (anti-AChR) · NMOSD (anti-AQP4) · cold-chain biological · meningococcal vaccination mandatory
Odevixibat (Bylvay)
IBAT inhibitor · pruritus in PFIC and Alagille syndrome
Velmanase alfa (Lamzede)
Enzyme replacement therapy · alpha-mannosidosis · 2-8°C
Maralixibat (Livmarli)
IBAT inhibitor · cholestatic pruritus in Alagille syndrome and PFIC
All gastroenterology
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for nitisinone.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Nitisinone supply, the specific questions.
What decides the Orfadin or nitisinone price for an importer?
We do not publish prices, so we cannot give an Orfadin price or a nitisinone price here. The landed cost depends on whether you choose the Orfadin originator or a generic or other registered nitisinone product, the presentation (capsule, oral suspension or tablet), the strength, the pack, the quantity, the registration route in your destination, the refrigerated freight lane for Orfadin and the Incoterms. M Care Exports quotes per destination once you send the product, strength, volume and country.
What is the difference between Orfadin 5 mg and Orfadin 10 mg?
Both are nitisinone capsules, and both are listed by the EU and US labels alongside the 2 mg and 20 mg capsules. The strengths allow dosing by body weight. In the EU the adult alkaptonuria dose is 10 mg once daily, which the 10 mg capsule matches. The EU SmPC allows a single room-temperature period of 3 months for the 5 mg, 10 mg and 20 mg capsules, but 2 months for the 2 mg capsule. Strength and the number of capsules per dose are set by the prescriber, not by us. Tell us the strengths your centre uses and we quote each as its own line.
Is there an Orfadin oral suspension, and how is it stored?
Yes. The US Orfadin label lists a 4 mg/mL oral suspension alongside the capsules, and the EU SmPC notes a 4 mg/mL oral suspension is also available. Both labels have the suspension kept in a refrigerator before first use. After opening, the US label allows room temperature up to 25 °C for up to 60 days, and the EU SmPC gives a single in-use period of 2 months. Check the label for your destination for exact in-use instructions, and tell us if you need the suspension so we plan the refrigerated lane.
Is there an Orfadin tablet, a Nityr tablet or a nitisinone tablet?
Orfadin itself is a capsule and an oral suspension, not a tablet. Tablets are sold under other names. In the US, Nityr tablets (2, 5 and 10 mg) are labelled for HT-1 and stored at room temperature, and Harliku 2 mg tablets are labelled for alkaptonuria. In the EU, the EMA lists Nityr 10 mg tablets as a generic of Orfadin, held by Cycle Pharmaceuticals (Europe) Ltd. We name these as separate brands and quote the one your destination registers.
What is Orfadin indicated for?
The EU SmPC lists hereditary tyrosinaemia type 1 in adults and children of any age, in combination with dietary restriction of tyrosine and phenylalanine, and alkaptonuria in adults. The US Orfadin label lists hereditary tyrosinaemia type 1 only. In the US, the alkaptonuria indication sits with Harliku tablets, which are indicated to reduce urine homogentisic acid in adults. Indication therefore depends on the market and the label, so check your destination registration before ordering.
Is there a generic of Orfadin, and can you supply other nitisinone brands?
Yes. In the EU, the EMA classes Nityr 10 mg tablets as a generic of Orfadin. In the US, DailyMed lists generic nitisinone capsules approved under abbreviated applications, for example from Par Health USA and Eton Pharmaceuticals. In the UK, the emc lists nitisinone hard capsules from other licence holders, including LogixX Pharma and Dipharma B.V. We do not assume any of these is registered in your destination. Tell us the destination and the presentation you need, and we confirm which nitisinone product we can supply and under what import route.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.