Drug

Who makes lomustine?

4 companies list lomustine as a human prescription drug, including under the names Gleostine. Forms: capsule; capsule, gelatin coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing lomustine

CompanyFormsApplicationNDCsRegistered sites
Carnegie Pharmaceuticals, LLCUnited StatescapsuleANDAANDA21926531
Azurity Pharmaceuticals, Inc.capsule, gelatin coatedNDANDA01758830
NextSource Biotechnology, LLCcapsule, gelatin coatedNDANDA01758830
Wilshire Pharmaceuticals, Inc.capsule, gelatin coatedNDANDA01758830

Bulk ingredient listings

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Common questions

Who makes lomustine?
4 companies list lomustine as a human prescription drug in the openFDA NDC Directory, led by Carnegie Pharmaceuticals, LLC, Azurity Pharmaceuticals, Inc., NextSource Biotechnology, LLC, Wilshire Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic Gleostine?
1 company lists lomustine under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies lomustine active ingredient?
1 company lists lomustine as a bulk ingredient, including Dr. Reddys Laboratories Limited.