Medicine
Sapropterin 100 mg powder for oral solution
Sapropterin 100 mg powder for oral solution 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 powder for oral solution at 20º to 25ºC (68º…
Key facts
- Active ingredient (INN)
- Sapropterin
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 30 packets, 1 packet, 1 powder and 4 more
- Manufacturers
- Camber PharmaceuticalsIndiaMicro LabsIndiaTruPharmaNorthStar RxLLCPar Health
- Origin register
- US FDA, United States
- Storage
- Store sapropterin dihydrochloride powder for oral solution at 20º to 25ºC (68º to 77ºF), excursions permitted between 15º to 30ºC (59º 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 1111018, 1653217DailyMed set ID 907e24c4-3337-4aee-b789-276e37a85cd8, b3999f74-920d-4444-afa7-f4211e4eb431, 3f0d6820-ff59-40c0-882f-aeea2dd1d1ad +2NDC 42571-509, 72603-193, 31722-047 +2Application ANDA219511, ANDA215420, ANDA207207 +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 |
|---|---|---|---|
| 30 packet in 1 carton / 1 powder, for solution in 1 packet | 31722-047-30 | Camber PharmaceuticalsIndia | 18 August 2022 |
| 1 packet in 1 carton / 1 powder, for solution in 1 packet | 31722-047-31 | Camber PharmaceuticalsIndia | 18 August 2022 |
| 30 packet in 1 carton / 1 powder, for solution in 1 packet | 42571-509-41 | Micro LabsIndia | 1 April 2026 |
| 30 packet in 1 carton / 1 powder, for solution in 1 packet | 49884-948-72 | Par Health | 1 October 2020 |
| 1 powder, for solution in 1 pouch | 52817-850-01 | Trupharma | 30 January 2026 |
| 30 powder, for solution in 1 carton | 52817-850-30 | Trupharma | 30 January 2026 |
| 30 packet in 1 carton / 1 powder, for solution in 1 packet | 72603-193-30 | 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 powder for oral solution.
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 powder for oral solution 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.