Last updated: May 23, 2026
Temodar is a branded temozolomide product. The practical way to map “suppliers” is to separate (1) finished-dose manufacturers that produce temozolomide for the US market, from (2) upstream active pharmaceutical ingredient (API) and critical intermediate suppliers, and (3) contract manufacturing organizations (CMOs) that package and distribute finished dosage units. This structure determines who can supply generics too, because both APIs and packaging lines are shared across products.
Which companies supply Temodar (temozolomide) finished drug in the US?
Answer: Temodar finished product supply is controlled by the company that holds the US NDA label and by the firms that manufacture and/or package the NDA product under contract. For a complete, actionable supplier list, the authoritative source is the FDA “Drug Label” manufacturing section and the Orange Book manufacturing information tied to each listed applicant/labeler and strength.
Orange Book basis
- Orange Book listings identify the NDA holder and the “applicant” associated with each listed drug submission.
- Orange Book does not always disclose all CMOs, but it anchors the labeler and listing structure needed to trace manufacturing sites through the FDA label.
FDA label manufacturing section (what to look for)
- “Manufactured for” / “Distributed by” sections that name the labeler or marketing authorization holder.
- “Manufacturing” or “Packaged by” lines that cite specific finished dosage manufacturers or packagers, often different from the labeler.
What is the Orange Book status of Temodar, and who is the NDA holder/applicant?
Answer: Temodar (temozolomide) is an established branded oncology drug with multiple Orange Book-listed strengths and regulatory listings. The Orange Book entry identifies the NDA holder/applicant tied to the listed drug and patents listed for that NDA.
What this tells you commercially
- NDA holder and applicant determine who controls branded supply and who can license or authorize manufacturing of branded product.
- The patent listing set determines the timing and risk profile for generic entry and parallel distribution.
How to interpret Temodar Orange Book listings for “supplier” mapping
- Match the Orange Book “applicant” name to the US labeler.
- Use the labeler’s identity to pull the “Manufactured by/for” lines on the packaging label.
- Identify strengths (for example, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg depending on historical availability) because each strength can have different manufacturing or packaging sites.
Do generic temozolomide suppliers compete with Temodar, and which firms manufacture generics?
Answer: Generic temozolomide manufacturers compete at the finished-dose level once patents and exclusivities allow. Generic firms also rely on the same upstream API supplier network, so generic entry can change the balance of power in sourcing.
How to map generic suppliers efficiently
- Use the Orange Book to list all approved ANDAs for temozolomide oral capsules.
- For each ANDA, use the FDA label to identify:
- the ANDA applicant/labeler
- the manufacturer of record
- the packager of record
Business impact
- If multiple ANDAs use the same API supplier or CMO, supply shocks can cascade.
- If only one or two finished-dose sites package specific strengths, shortages tend to cluster by strength.
Which API suppliers make temozolomide for finished-dose manufacturers?
Temozolomide API sourcing is typically handled through specialized chemical manufacturing and controlled-substance-like oncology QA systems, with qualification requirements tied to cGMP, impurity profiles, residual solvents, and stability.
Practical sourcing conclusion
- Upstream API suppliers are usually not publicly enumerated in Orange Book listings.
- The most reliable supplier map is built from:
- FDA labels for each ANDA (manufacturer of record)
- inspection databases and assignment patterns across multiple ANDAs
- supplier disclosures in DMFs tied to temozolomide processes (not always public at a company-by-company level)
Because this request is for “suppliers,” a complete list must be anchored in identified manufacturing sites or labeled “manufactured by/for” entities for both branded and generic product. Without confirmed label-and-site mapping, any named API suppliers would be incomplete or inaccurate.
What contract manufacturers (CMOs) package Temodar and temozolomide capsules?
Answer: Temodar is packaged as oral capsules, and packaging is frequently performed at a different facility than API synthesis. Packaging sites for branded and generic versions often converge, but they can also diverge by strength due to line availability and blister/bottle packaging configurations.
What to extract from labels
- “Packaged by” and “Manufactured for” lines.
- Site addresses that identify specific packaging operations.
- Variations across strengths indicate different packaging suppliers.
Risk implications
- Packaging shortages show up as missing strengths first.
- Distribution disruptions affect oncology supply disproportionately because demand is recurring and patients require consistent capsule dosing.
How does the Temodar supply chain differ by capsule strength and packaging configuration?
Answer: Strength-level differences drive separate manufacturing and packaging runs. Where supply constraints occur, shortages usually concentrate in one or two capsule strengths rather than the full catalog.
What to check in practice
- Bottle vs blister packaging.
- Capsule strength availability and interchangeability.
- Label manufacturing site changes by strength.
What supply risks matter most for temozolomide (Temodar)?
Key risk categories for oncology capsule products:
- Specialized API manufacturing yield and impurity control.
- Heat and moisture sensitivity affecting capsule integrity and shelf-life stability.
- QC release timelines for small-batch runs.
- Packaging-line capacity for specific strengths and container types.
Operational takeaway
- “Supplier” lists should be strength-specific if you are building a redundancy plan for procurement.
What patent and exclusivity factors affect who can supply Temodar-like products?
Temozolomide’s patent estate does not block all supply immediately, but it impacts:
- when ANDAs can reference the branded NDA and launch
- when Paragraph IV challenges occur (for first generic or additional entrants)
- whether settlement agreements delay generic launches
This matters because the pool of qualified generic suppliers is often the dominant practical “supplier” source after branded exclusivity periods.
Comparison: Temodar branded supply vs generic temozolomide supplier landscape
Answer: Branded supply is tied to the NDA holder’s approved manufacturing network. Generic supply is broader and fragmented across ANDA applicants and their contract manufacturers. The competitive supplier landscape changes by strength and by packaging configuration.
How to structure the supplier comparison
- Branded:
- labeler
- finished-dose manufacturer(s)
- packager(s)
- Generics:
- ANDA applicants
- manufacturer of record for each ANDA
- packager(s) for each strength
Key Takeaways
- “Suppliers for Temodar” must be mapped by finished-dose manufacturing and packaging sites, because upstream API supplier lists are not reliably public.
- The authoritative way to identify named supplier entities is through the FDA label manufacturing/packaging sections and Orange Book applicant/labeler matching for each Temodar strength.
- Generic temozolomide supply expands the set of finished-dose suppliers; supplier concentration can still be high at packaging or API synthesis nodes.
- Supply risks cluster by capsule strength, packaging configuration, and release/QC throughput.
FAQs
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How do I identify the finished-dose manufacturer for Temodar capsules by strength?
Use the Temodar package insert and label “Manufactured for” / “Manufactured by” / “Packaged by” lines for each strength listed on the bottle.
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Which firms are the ANDA applicants for generic temozolomide capsules listed in the Orange Book?
Pull the Orange Book “temozolomide” entries by strength and record each ANDA applicant name.
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Do multiple generic temozolomide products use the same manufacturing sites?
Often yes at the packager or manufacturer-of-record level; compare manufacturer/packager names across ANDA labels for the same strength.
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What supply shortages most commonly affect temozolomide?
Shortages most often affect specific capsule strengths and packaging formats due to bottlenecked packaging lines and batch release schedules.
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How do patent listings influence when new temozolomide suppliers can launch generics?
Patent and exclusivity status tied to the NDA controls ANDA approval and first-entrant launch timing, which determines the addition of new finished-dose suppliers.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Temozolomide / Temodar entry).
- U.S. Food and Drug Administration. Prescribing Information and Drug Labeling for Temodar (temozolomide).
- U.S. Food and Drug Administration. Approved Drug Products: temozolomide ANDA labels (manufacturer/packager of record).
