Medicine
Daybue 200 mg/mL oral solution
Daybue 200 mg/mL oral solution is a prescription medicine containing Trofinetide for oral use, marketed by Acadia Pharmaceuticals, 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 DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Trofinetide
- Brand
- Daybue
- Strength
- 200 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Acadia Pharmaceuticals
- Manufacturer
- Acadia Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX24 Trofinetide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 March 2023
- Identifiers
- RxCUI 2632857, 2632863, 2729447 +5DailyMed set ID 67e6f2d9-21f6-466f-9def-826c6a4b8257NDC 63090-660Application NDA217026
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 |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 450 mL in 1 bottle, plastic | 63090-660-01 | Acadia Pharmaceuticals | 10 March 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
Other strengths and forms of Trofinetide
Clinical summary
Trofinetide is a prescription medicine indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. It is available as powder for oral solution and oral solution. MedsAcross supplies Trofinetide 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 TrofinetideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Daybue prescribing information (Acadia Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Daybu: European public assessment report (EPAR) · European Medicines Agency
Need Daybue 200 mg/mL 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.