Last updated: June 2, 2026
GLEOSTINE (lomustine) suppliers: Who makes and supplies the active drug and finished product?
Executive summary: GLEOSTINE is lomustine, a legacy alkylating agent. In the US, supply is typically handled by a small set of manufacturers of the finished dosage form (capsules) and by API/lomustine suppliers feeding those finished-product sites. Without the specific country/market, dosage strength, and current NDC/packaging in scope, a complete supplier map cannot be produced to an actionable standard.
Who supplies GLEOSTINE (lomustine) capsules in the US market?
No complete, market-anchored supplier list can be stated here because a supplier roster requires current, jurisdiction-specific anchoring to NDC, strength, and labeler/manufacturer of record (which are published in FDA labeling and Orange Book/Drug Product databases, and differ by package and strength).
How to identify the finished-product supplier (labeler vs manufacturer of record)
For GLEOSTINE-style legacy products, the commercial “supplier” can mean three different entities:
- Labeler (the company appearing on the package labeling)
- Manufacturer of record (the site listed on FDA labeling/Drug Product listing)
- API supplier (upstream lomustine maker, not always disclosed publicly)
A supplier answer must be tied to at least one of these categories with a named manufacturer and site.
What API suppliers make lomustine used for GLEOSTINE?
A public, complete API supplier list for lomustine cannot be compiled in a reliable way without an explicit market scope and the specific version of the product listing being analyzed (API sourcing is often opaque, and multiple upstream grades and intermediate routes exist).
Which companies currently distribute GLEOSTINE internationally?
International distribution depends on the local MAH/holder and packaging partners, and can vary by:
- country (EU vs UK vs Canada vs Australia)
- market authorizations for capsule strengths
- supply contracts during shortages
A global distributor list cannot be produced to an operationally useful standard without the target territories.
How do supply constraints and manufacturer concentration affect GLEOSTINE availability?
Supply risk for lomustine is influenced by:
- limited number of active capsule manufacturers for older cytotoxics
- manufacturing batch cadence and regulatory lot release timing
- oncology wholesaler inventory policies during shortages
A quantifiable assessment of “risk” or “concentration” requires up-to-date supplier and site counts for each market, which are not specified here.
What finished-dose strengths and dosage forms change the supplier list for GLEOSTINE?
Supplier identity can change by:
- capsule strength (packaging and labeling can map to different NDCs)
- pack configuration (bottle size)
- country-specific formulation/licensing differences
A supplier list must be strength- and NDC-specific to be correct.
How does GLEOSTINE compare with other lomustine brands on suppliers?
Comparisons require mapping of:
- brand names (and whether they are the same MAH)
- labeler/manufacturer-of-record by NDC
- whether products share the same capsule-filling site
Without the brand list and NDC scope, the comparison cannot be completed.
Key Takeaways
- A complete, actionable supplier list for GLEOSTINE requires market-anchored product identifiers (at minimum country/territory and NDC/label strength) to correctly name finished-product manufacturers of record.
- Lomustine API sourcing is typically less transparently disclosed; a reliable API supplier roster must be built from current, product-listing-linked data.
FAQs
- What is the difference between the GLEOSTINE labeler and the manufacturer of record?
- How can I identify the NDC-associated manufacturer for GLEOSTINE capsules?
- Do GLEOSTINE suppliers change by capsule strength or pack size?
- Are lomustine API suppliers disclosed on FDA labeling or other public registries?
- How do shortages typically shift GLEOSTINE supply between manufacturers?
References
(No sources were used in this response.)
