Suppliers and packagers for generic pharmaceutical drug: temozolomide

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
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1366-03	5 PACKET in 1 CARTON (0085-1366-03) / 1 CAPSULE in 1 PACKET (0085-1366-05)	1999-08-11
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1366-04	14 PACKET in 1 CARTON (0085-1366-04) / 1 CAPSULE in 1 PACKET (0085-1366-05)	1999-08-11
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1417-02	5 PACKET in 1 CARTON (0085-1417-02) / 1 CAPSULE in 1 PACKET (0085-1417-03)	1999-08-11
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1425-03	5 PACKET in 1 CARTON (0085-1425-03) / 1 CAPSULE in 1 PACKET (0085-1425-05)	1999-08-11
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029	NDA	Merck Sharp & Dohme LLC	0085-1425-04	14 PACKET in 1 CARTON (0085-1425-04) / 1 CAPSULE in 1 PACKET (0085-1425-05)	1999-08-11

Suppliers and packagers for generic pharmaceutical drug: 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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