Medicine
Simtriyo 210 mg extended-release capsule
Simtriyo 210 mg extended-release capsule is a prescription medicine containing Centanafadine for oral use, marketed by Otsuka America Pharmaceutical, 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 at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Centanafadine
- Brand
- Simtriyo
- Strength
- 210 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 2 blister pack, 30 capsules
- Marketing authorisation holder
- Otsuka America Pharmaceutical
- Manufacturer
- Otsuka America Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 October 2026
- Identifiers
- RxCUI 2755002, 2755009, 2755012 +3DailyMed set ID ecfa41cc-c8c8-419b-8da3-ee5b819398c2NDC 59148-303Application NDA218145
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 |
|---|---|---|---|
| 2 blister pack in 1 carton / 7 capsule, extended release in 1 blister pack | 59148-303-07 | Otsuka America Pharmaceutical | 24 October 2026 |
| 30 capsule, extended release in 1 bottle | 59148-303-13 | Otsuka America Pharmaceutical | 24 October 2026 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 July 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Centanafadine
Clinical summary
Centanafadine is a prescription medicine indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg. MedsAcross supplies Centanafadine 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 CentanafadineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SIMTRIYO prescribing information (Otsuka America Pharmaceutical) · U.S. National Library of Medicine, DailyMed
Need Simtriyo 210 mg extended-release capsule 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.