Medicine
Javygtor 100 mg tablet
Javygtor 100 mg tablet is a prescription medicine containing Sapropterin for oral use, marketed by Dr. Reddy's Laboratories, 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 JAVYGTOR at 20°C to 25°C (68°F to 77°F). Protect from moisture.
Key facts
- Active ingredient (INN)
- Sapropterin
- Brand
- Javygtor
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets, 500 tablets, 30 tablets
- Marketing authorisation holder
- Dr. Reddy's Laboratories
- Manufacturer
- Dr. Reddy's LaboratoriesIndia
- Origin register
- US FDA, United States
- Storage
- Store JAVYGTOR at 20°C to 25°C (68°F to 77°F). 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
- 3 October 2022
- Identifiers
- RxCUI 1486687, 2612671DailyMed set ID d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4NDC 43598-096Application ANDA207685
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 |
|---|---|---|---|
| 120 tablet in 1 bottle | 43598-096-04 | Dr. Reddy's LaboratoriesIndia | 3 October 2022 |
| 500 tablet in 1 bottle | 43598-096-05 | Dr. Reddy's LaboratoriesIndia | 3 October 2022 |
| 30 tablet in 1 bottle | 43598-096-30 | Dr. Reddy's LaboratoriesIndia | 3 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
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 Javygtor 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.