Medicine
Ameluz 10% gel
Ameluz 10% gel is a prescription medicine containing Aminolevulinic acid for topical use, marketed by Biofrontera, 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 AMELUZ in a refrigerator, 2°C to 8°C (36°F to 46°F). Excursions…
Key facts
- Active ingredient (INN)
- Aminolevulinic acid
- Brand
- Ameluz
- Strength
- 10%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube, 10 tubes
- Marketing authorisation holder
- Biofrontera
- Manufacturer
- Biofrontera
- Origin register
- US FDA, United States
- Storage
- Store AMELUZ in a refrigerator, 2°C to 8°C (36°F to 46°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C to 8°C (36°F to 46°F) if the tube is tightly closed.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XD04 Aminolevulinic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 August 2016
- Identifiers
- RxCUI 1806645, 1806650DailyMed set ID 650daa9f-aeec-49ce-95b9-5fa20b988afdNDC 70621-101Application NDA208081
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 tube in 1 package / 2 g in 1 tube | 70621-101-10 | Biofrontera | 1 June 2017 |
| 10 tube in 1 package / 2 g in 1 tube | 70621-101-20 | Biofrontera | 10 May 2021 |
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 3 December 1999 | 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 Aminolevulinic acid
Clinical summary
Aminolevulinic acid is an optical imaging agent indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. MedsAcross supplies Aminolevulinic acid 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 Aminolevulinic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LEVULAN KERASTICK prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Ameluz 10% 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.