Medicine
Ztalmy 50 mg/mL oral suspension
Ztalmy 50 mg/mL oral suspension is a prescription medicine containing Ganaxolone for oral use, marketed by Immedica Pharma, 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 ZTALMY in its original bottle in an upright position at 20°C to 25°C…
Key facts
- Active ingredient (INN)
- Ganaxolone
- Brand
- Ztalmy
- Strength
- 50 mg/mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Immedica Pharma
- Manufacturer
- Immedica Pharma
- Origin register
- US FDA, United States
- Storage
- Store ZTALMY in its original bottle in an upright position at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CV
- ATC code
- N03AX Anticonvulsant agent, subgroup N03AX
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 June 2022
- Identifiers
- RxCUI 2604694, 2604700DailyMed set ID d91612c4-b03a-4be4-a1ee-6a13e3b83d4eNDC 81583-100Application NDA215904
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 / 110 mL in 1 bottle, plastic | 81583-100-01 | Immedica Pharma | 6 June 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
Clinical summary
Ganaxolone is a neuroactive steroid gamma-aminobutyric acid A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. MedsAcross supplies Ganaxolone 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 GanaxoloneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZTALMY prescribing information (Immedica Pharma) · U.S. National Library of Medicine, DailyMed
- Ztalmy: European public assessment report (EPAR) · European Medicines Agency
Need Ztalmy 50 mg/mL oral suspension 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.