Medicine
Gleostine 40 mg capsule
Gleostine 40 mg capsule is a prescription medicine containing Lomustine for oral use, marketed by Azurity Pharmaceuticals, 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 at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)…
Key facts
- Active ingredient (INN)
- Lomustine
- Brand
- Gleostine
- Strength
- 40 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Azurity Pharmaceuticals
- Manufacturers
- Azurity PharmaceuticalsNextSource Biotechnology
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Avoid temperatures over 40°C (104°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AD02 Lomustine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 August 2014
- Identifiers
- RxCUI 197894, 197895, 197896 +3DailyMed set ID 7f77526b-4c40-409c-82ea-d0f934d89cc2, 3529fe2f-3c23-4862-bb20-b48026957082NDC 58181-3041, 24338-341Application NDA017588
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 / 5 capsule, gelatin coated in 1 bottle | 24338-341-05 | Azurity Pharmaceuticals | 24 October 2025 |
| 1 bottle in 1 carton / 5 capsule, gelatin coated in 1 bottle | 58181-3041-5 | NextSource Biotechnology | 18 August 2014 |
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 4 August 1976 | 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 Lomustine 40 mg capsule.
Other strengths and forms of Lomustine
Clinical summary
Lomustine is an alkylating drug indicated for the treatment of patients with brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Lomustine 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 LomustineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lomustine prescribing information (Wilshire Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Gleostine 40 mg capsule 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.