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Who makes gemcitabine?

7 companies list gemcitabine as a human prescription drug, including under the names AVGEMSI. Forms: injection, powder, lyophilized, for solution; injection, solution. Routes: intravenous.

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 gemcitabine

CompanyFormsApplicationNDCsRegistered sites
Hospira, Inc.United Statesinjection, powder, lyophilized, for solution; injection, solutionANDA, NDAANDA078339, ANDA079183, NDA20079567
Fresenius Kabi USA, LLCUnited Statesinjection, powder, lyophilized, for solutionANDAANDA09079936
Hikma Pharmaceuticals USA Inc.United Statesinjection, solutionANDAANDA21317534
BluePoint Laboratories Inc.injection, solutionNDANDA20960430
Dr. Reddy's Laboratories LimitedIndiainjection, powder, lyophilized, for solutionANDAANDA091365215
Avyxa GmbHSwitzerlandinjection, solutionNDANDA21992021
Sagent Pharmaceuticalsinjection, solutionANDAANDA20907710

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Common questions

Who makes gemcitabine?
7 companies list gemcitabine as a human prescription drug in the openFDA NDC Directory, led by Hospira, Inc., Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., BluePoint Laboratories Inc., Dr. Reddy's Laboratories Limited. 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 AVGEMSI?
5 companies list gemcitabine 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 gemcitabine active ingredient?
2 companies list gemcitabine as a bulk ingredient, including ScinoPharm Taiwan, Ltd., Valary Lab Private Limited.