Medicine
Nulibry 9.5 mg powder for injection
Nulibry 9.5 mg powder for injection is a prescription medicine containing Fosdenopterin for intravenous use, marketed by Sentynl Therapeutics, 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 NULIBRY frozen between -25°C and -10°C (-13°F and 14°F). Store vial in…
Key facts
- Active ingredient (INN)
- Fosdenopterin
- Brand
- Nulibry
- Strength
- 9.5 mg
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Sentynl Therapeutics
- Manufacturer
- Sentynl Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store NULIBRY frozen between -25°C and -10°C (-13°F and 14°F). Store vial in original carton to protect from light. For storage recommendations for the reconstituted solution.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX19 Fosdenopterin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 March 2021
- Identifiers
- RxCUI 2531292, 2531297DailyMed set ID 736aeea3-f206-454d-95d0-fd30964e8aabNDC 42358-295Application NDA214018
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 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 42358-295-01 | Sentynl Therapeutics | 28 October 2022 |
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
Clinical summary
Fosdenopterin is a cyclic pyranopterin monophosphate. It is available as powder for injection for intravenous use. MedsAcross supplies Fosdenopterin 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 FosdenopterinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nulibry prescribing information (Sentynl Therapeutics) · U.S. National Library of Medicine, DailyMed
- Nulibry: European public assessment report (EPAR) · European Medicines Agency
Need Nulibry 9.5 mg powder for injection 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.