Last Updated: June 24, 2026

Suppliers and packagers for TEMOZOLOMIDE


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TEMOZOLOMIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-048-53 1 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASS 2017-03-07
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-048-54 1 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASS 2017-03-07
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-049-53 1 BOTTLE, GLASS in 1 CARTON (16729-049-53) / 5 CAPSULE in 1 BOTTLE, GLASS 2017-03-07
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-049-54 1 BOTTLE, GLASS in 1 CARTON (16729-049-54) / 14 CAPSULE in 1 BOTTLE, GLASS 2017-03-07
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-050-53 1 BOTTLE, GLASS in 1 CARTON (16729-050-53) / 5 CAPSULE in 1 BOTTLE, GLASS 2017-03-07
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-050-54 1 BOTTLE, GLASS in 1 CARTON (16729-050-54) / 14 CAPSULE in 1 BOTTLE, GLASS 2017-03-07
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

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Suppliers and packagers for TEMOZOLOMIDE

Last updated: May 26, 2026

Temozolomide Suppliers: Active Ingredient, Finished Dose Manufacturers, and Supply Chain Risks (FDA + Global)

Temozolomide supply sits in a relatively narrow pipeline of API and finished-dose manufacturers, with the highest concentration among global generic and oncology-specialty suppliers supplying the U.S. market through ANDA distribution channels. In practice, buyers source temozolomide in two tracks: (1) ANDA-labeled capsules (commonly 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg) and (2) API via CMOs and API producers contracted by finished-dose players.

Core actionable takeaway: to assess commercial continuity and legal risk, you map (i) FDA label holders for temozolomide capsules, (ii) Orange Book patent coverage for each listed NDA/ANDA strength, and (iii) whether the product is supplied through single-site or multi-site manufacturing for solid oral dose.

No reliable, complete supplier roster can be produced from the information provided in the prompt alone.

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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