Medicine
Sephience 1000 mg oral powder
Sephience 1000 mg oral powder is a prescription medicine containing Sepiapterin for oral use, marketed by PTC 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 SEPHIENCE liquid or soft food mixture either refrigerated or at…
Key facts
- Active ingredient (INN)
- Sepiapterin
- Brand
- Sephience
- Strength
- 1000 mg
- Dosage form
- Oral powder
- Route
- Oral
- Packs
- 30 packets
- Marketing authorisation holder
- PTC Therapeutics
- Manufacturers
- PTC Therapeuticsallphamed Pharbil Arzneimittel
- Origin register
- US FDA, United States
- Storage
- Store SEPHIENCE liquid or soft food mixture either refrigerated or at controlled room temperature. Store SEPHIENCE at room temperature between 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX28 Sepiapterin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 July 2025
- Identifiers
- RxCUI 2723061, 2723067, 2723069 +1DailyMed set ID 32ac719c-49f0-4105-9c46-18c19583a5c2, 9fabfee2-9488-4d03-b203-8fa50f9a7f55NDC 52856-301, 60468-006Application NDA219666
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 |
|---|---|---|---|
| 30 packet in 1 carton / 1 powder in 1 packet | 52856-301-03 | PTC Therapeutics | 28 July 2025 |
| 30 packet in 1 carton / 1 powder in 1 packet | 60468-006-03 | allphamed Pharbil Arzneimittel | 28 July 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.
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 Sepiapterin
Clinical summary
Sepiapterin is a prescription medicine indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). It is available as oral powder. MedsAcross supplies Sepiapterin 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 SepiapterinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sephience prescribing information (PTC Therapeutics) · U.S. National Library of Medicine, DailyMed
- Sephience: European public assessment report (EPAR) · European Medicines Agency
Need Sephience 1000 mg oral powder 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.