Medicine
Adapalene 0.3% gel
Adapalene 0.3% gel is a generic prescription medicine for topical use, made by 6 labelers, 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
Protect from freezing. Store at controlled room temperature 68° to 77°F (20°…
Key facts
- Active ingredient (INN)
- Adapalene
- Brand
- Sold under the generic name
- Strength
- 0.3%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube, 1 bottle and 8 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackEncube EthicalsMayne Pharma CommercialActavis Pharma
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AD03 Adapalene
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 October 2014
- Identifiers
- RxCUI 722111DailyMed set ID 56045eee-e84d-467a-9e12-e62bd474ed8a, 5dd6d825-f7c4-4a86-82cc-fcbb41df8542, a3b6f3c3-d615-4b00-a76f-134b75e30a50 +4NDC 21922-051, 46708-549, 62332-549 +4Application ANDA200298, ANDA213508, NDA021753 +2
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 15 g in 1 tube | 46708-549-15 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 46708-549-45 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 46708-549-46 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-1377-6 | Sun Pharmaceutical IndustriesIndia | 23 June 2016 |
| 1 tube in 1 carton / 45 g in 1 tube | 0472-0126-45 | Actavis Pharma | 27 October 2014 |
| 1 tube in 1 carton / 45 g in 1 tube | 21922-051-06 | Encube Ethicals | 10 August 2023 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 21922-051-50 | Encube Ethicals | 10 August 2023 |
| 1 tube in 1 carton / 45 g in 1 tube | 68308-666-25 | Mayne Pharma Commercial | 26 February 2024 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 68308-666-45 | Mayne Pharma Commercial | 26 February 2024 |
| 1 tube in 1 carton / 45 g in 1 tube | 72162-2295-2 | Bryant Ranch Prepack | 30 April 2024 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 72162-2295-4 | Bryant Ranch Prepack | 30 April 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 31 May 1996 | 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
Alternatives
Other makers and brands of Adapalene 0.3% gel.
Other strengths and forms of Adapalene
Clinical summary
Adapalene is a retinoid indicated for the topical treatment of acne vulgaris. It is available as gel, cream and swabs for topical use. MedsAcross supplies Adapalene 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 AdapaleneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Adapalene prescribing information (Padagis Israel Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Adapalene 0.3% 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.