Medicine
Sapropterin 100 mg tablet
Sapropterin 100 mg tablet is a generic prescription medicine for oral use, made by 5 labelers, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store sapropterin dihydrochloride tablets at 20ºC to 25ºC (68ºF to 77ºF)…
Key facts
- Active ingredient (INN)
- Sapropterin
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets, 240 tablets, 30 tablets and 4 more
- Manufacturers
- Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaHikma PharmaceuticalsNorthStar RxLLCPar Health
- Origin register
- US FDA, United States
- Storage
- Store sapropterin dihydrochloride tablets at 20ºC to 25ºC (68ºF to 77ºF), excursions allowed between 15ºC to 30ºC (59ºF to 86ºF). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX07 Sapropterin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 October 2020
- Identifiers
- RxCUI 1486687DailyMed set ID ec8ea96c-8ec1-4301-a85d-d59562e548ca, c4d92cce-e899-4f14-b19c-5e17f9922215, a64a50ba-e3da-4227-9bce-87101d60409e +2NDC 31722-045, 0054-0906, 72603-191 +2Application ANDA215534, ANDA218797, ANDA207200 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 tablet in 1 bottle | 59651-574-08 | Aurobindo PharmaIndia | 9 June 2025 |
| 240 tablet in 1 bottle | 59651-574-24 | Aurobindo PharmaIndia | 9 June 2025 |
| 30 tablet in 1 bottle | 59651-574-30 | Aurobindo PharmaIndia | 9 June 2025 |
| 120 tablet in 1 bottle | 31722-045-12 | Camber PharmaceuticalsIndia | 23 August 2022 |
| 120 tablet in 1 bottle | 0054-0906-23 | Hikma Pharmaceuticals | 23 October 2025 |
| 120 tablet in 1 bottle | 49884-720-08 | Par Health | 1 October 2020 |
| 120 tablet in 1 bottle | 72603-191-01 | NorthStar RxLLC | 1 December 2023 |
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 Sapropterin 100 mg tablet.
Other strengths and forms of Sapropterin
Clinical summary
Sapropterin is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). MedsAcross supplies Sapropterin 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 SapropterinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Kuvan prescribing information (BioMarin Pharmaceutical) · U.S. National Library of Medicine, DailyMed
- Kuvan: European public assessment report (EPAR) · European Medicines Agency
- Sapropterin Dipharma: European public assessment report (EPAR) · European Medicines Agency
Need Sapropterin 100 mg tablet 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.