Medicine
Sofdra 87 mg/0.67 mL gel
Sofdra 87 mg/0.67 mL gel is a prescription medicine containing Sofpironium for topical use, marketed by Botanix SB, 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 upright at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to…
Key facts
- Active ingredient (INN)
- Sofpironium
- Brand
- Sofdra
- Strength
- 87 mg/0.67 mL
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 bottle
- Marketing authorisation holder
- Botanix SB
- Manufacturer
- Botanix SB
- Origin register
- US FDA, United States
- Storage
- Store upright at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 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
- 6 August 2024
- Identifiers
- RxCUI 2689326, 2689332DailyMed set ID 78f86f4f-658c-468b-bd54-49182ddcc7acNDC 83723-010Application NDA217347
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 in 1 carton / 50 mL in 1 bottle | 83723-010-50 | Botanix SB | 6 August 2024 |
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 18 June 2024 | 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
Clinical summary
Sofpironium is a prescription medicine indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. It is available as gel for topical use. MedsAcross supplies Sofpironium 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 SofpironiumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sofdra prescribing information (Botanix SB) · U.S. National Library of Medicine, DailyMed
Need Sofdra 87 mg/0.67 mL gel 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.