Medicine
Levulan Kerastick kit
Levulan Kerastick kit is a prescription medicine containing Aminolevulinic acid, marketed by Sun Pharmaceutical Industries, 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 between 20° - 25 °C (68° - 77 °F), excursions permitted to 15°- 30 °C…
Key facts
- Active ingredient (INN)
- Aminolevulinic acid
- Brand
- Levulan Kerastick
- Dosage form
- Kit
- Packs
- 1 kit, 2 applicators, 6 applicators
- Marketing authorisation holder
- Sun Pharmaceutical Industries
- Manufacturer
- Sun Pharmaceutical IndustriesIndia
- Origin register
- US FDA, United States
- Storage
- Store between 20° - 25 °C (68° - 77 °F), excursions permitted to 15°- 30 °C (59° - 86 °F).
- Cold chain
- Not required on record
- 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
- 4 September 2000
- Identifiers
- RxCUI 762672, 762674DailyMed set ID e45cc371-9ebc-4904-12bc-65cb4e2817adNDC 67308-101Application NDA020965
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 kit in 1 applicator * 1.5 mL in 1 ampule * 1.5 mL in 1 ampule | 67308-101-01 | Sun Pharmaceutical IndustriesIndia | 4 September 2000 |
| 2 applicator in 1 carton / 1 kit in 1 applicator * 1.5 mL in 1 ampule * 1.5 mL in 1 ampule | 67308-101-02 | Sun Pharmaceutical IndustriesIndia | 20 December 2000 |
| 6 applicator in 1 carton / 1 kit in 1 applicator * 1.5 mL in 1 ampule * 1.5 mL in 1 ampule | 67308-101-06 | Sun Pharmaceutical IndustriesIndia | 24 September 2000 |
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 Levulan Kerastick kit 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.