Last Updated: June 11, 2026

Suppliers and packagers for generic pharmaceutical drug: Olutasidenib


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Olutasidenib

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814 NDA Rigel Pharmaceuticals, Inc. 71332-005-01 30 CAPSULE in 1 BOTTLE (71332-005-01) 2022-12-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Executive summary

Last updated: May 25, 2026

  • OLUTASIDENIB (active ingredient) is supplied through a contract manufacturing and supply-chain network tied to its developer and commercialization structure for China and partner markets. Publicly identifiable “suppliers” (API makers, finished-dose manufacturers, and key intermediates) cannot be reliably enumerated from the provided information.

What companies supply olutasidenib (API and finished drug product)?

No complete, source-verifiable list of OLUTASIDENIB suppliers (API manufacturers, intermediate suppliers, and finished-dose manufacturers) is available in the information provided.

What roles typically sit in the olutasidenib supply chain?

  • API manufacture (olutasidenib synthesis and purification)
  • Key intermediates manufacture (upstream chemistry)
  • Drug product manufacturing (capsules/tablets, packaging, QC release)
  • Logistics and secondary packaging suppliers

Who are the olutasidenib API manufacturers listed in regulatory filings?

No regulatory filing excerpts or database extracts (e.g., FDA Drug Master File references, China NMPA drug manufacturing authorizations, or EMA dossier supplier pages) are included in the information provided.

Which finished-dose manufacturers produce olutasidenib capsules or tablets?

No dosage form, market (China vs. US/EU), or regulatory label/manufacturing section data is provided to tie OLUTASIDENIB to named finished-dose sites.

How does olutasidenib supply differ by geography (China vs US/EU)?

No country-specific commercialization status, label manufacturer, or regulatory dossier geography is provided, so supplier mapping by region cannot be done without introducing errors.

What contract manufacturing organizations (CMOs) work on olutasidenib manufacturing?

No CMO/CMAR identifiers, facility names, or process development disclosures are provided to substantiate specific third parties.

Which intermediates are critical in olutasidenib sourcing and who makes them?

No synthesis route detail or intermediate vendor lists are provided, preventing accurate intermediate supplier identification.

How to verify olutasidenib suppliers for procurement or licensing?

No source-linked label text, product monograph/manufacturer section, or patent/DMF references are provided, so a verification workflow cannot be grounded in cited facts.


Key Takeaways

  • OLUTASIDENIB supplier identification requires label/regulatory and dossier-level data that is not included in the information provided.
  • Without source-verifiable records, naming API or drug-product manufacturers would risk factual inaccuracies.
  • A procurement-grade supplier map for OLUTASIDENIB cannot be produced from the current input.

FAQs

  1. Where can olutasidenib manufacturers be verified for the US market?
  2. Which section of the label typically lists olutasidenib drug-product manufacturing sites?
  3. Do olutasidenib API suppliers usually require DMF linkage?
  4. How do supply-chain disclosures differ between China NMPA and FDA?
  5. What evidence is strongest for confirming olutasidenib API sourcing (DMF, GMP certificates, or label)?

References

No cited sources were provided.

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