Suppliers and packagers for generic pharmaceutical drug: CEDAZURIDINE; DECITABINE

CEDAZURIDINE; DECITABINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576	NDA	Taiho Pharmaceutical Co., Ltd.	64842-0727-9	1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK	2020-07-07

Suppliers for Cedazuridine and Decitabine (Opdivo/Orange Book-Linked Inputs, CDAs, and Contract Manufacturing)

Last updated: May 24, 2026

Cedazuridine and decitabine are supplied through a concentrated upstream ecosystem that includes active pharmaceutical ingredient (API) makers, nucleoside analogue specialists, and contract manufacturing organizations (CMOs) that package combination tablet strengths and run low-temperature, moisture-controlled manufacturing. Downstream sourcing is typically governed by Drug Master File (DMF) referencing, quality agreements, and audit-driven controls because both actives are nucleoside analogs with strict impurity specifications.

Which companies supply cedazuridine and decitabine APIs for commercial manufacturing?

Short answer: API supply is dominated by a small number of global nucleoside and oligonucleotide supply chains, with commercial drug product manufacturing handled by branded and generic-ready CMOs under NDA and QMS integration. For cedazuridine/decitabine fixed-dose combination, supply chains are anchored to DMF-backed API producers and finished-dose manufacturers supporting NDA and lifecycle changes.

Cedazuridine and decitabine are typically sourced via DMF-referenced APIs

• API suppliers generally commercialize nucleoside analogs through:
  • DMF or ASMF (EU) filings that enable direct referencing in regulatory submissions
  • controlled impurity profiles and residual solvent limits
  • cold-chain or controlled-room storage practices depending on grade and solid form

What matters when choosing API suppliers

• Nitrosamine and reactive impurity risk controls (common for nucleoside analogs)
• Thermostability and hydrate control (solid-state handling)
• Endotoxin and particulate controls for sterile downstream processes are not central here, but microbiological specs and bioburden control still drive warehouse and formulation acceptance criteria
• Analytical method transfer capacity for impurities and enantiomeric or isomeric variants

How do cedazuridine and decitabine supplier lists differ between APIs and finished dose?

Short answer: Finished-dose manufacturers are not the same entities as API producers. For cedazuridine/decitabine, many API suppliers feed either:

• the brand’s internal supply chain, or
• contract finished-dose manufacturing partners that run stability-tested blistering and pack-line operations.

Typical split

• API manufacturers: nucleoside analogue API producers with DMF/ASMF coverage
• CMOs for tablets: solid oral dose CDMOs with validated blending, granulation if applicable, compression, coating, and blister packaging

What patent constraints affect supplier qualification for cedazuridine and decitabine?

Fixed-dose combination manufacturing and lifecycle improvements can create constraints through:

• process patents (API route, purification, polymorph control, crystallization)
• formulation patents (tablet composition and dissolution profile)
• method-of-use patents tied to dosing and indication
• regulatory exclusivity tied to originator filings and permitted reference

Why patent estates change supplier risk

• API suppliers may sell general nucleoside analogs, but the combination product’s specific commercial manufacturing routes can be locked by:
  • proprietary purification steps
  • impurity targets tied to safety margins
  • tablet excipient selections that appear in formulation patents

Supplier diligence typically focuses on

• whether the API route falls within or outside active patents
• whether supplier intermediates are controlled
• whether the finished dose route can be practiced without infringing formulation/process claims

When does cedazuridine and decitabine lose exclusivity, and how does that change sourcing?

Short answer: Exclusivity and patent expiry timelines determine when additional qualified suppliers can enter or scale. As exclusivity narrows, CMOs and API players expand due diligence-to-qualification cycles and bid for commercial manufacturing slots.

Sourcing inflection points are usually driven by

• Orange Book patent status changes
• expiration of composition-of-matter and formulation patents
• settlement-driven entry dates after Paragraph IV litigation (if filed)

What generic entry risks exist for cedazuridine/decitabine supply chains?

Short answer: Entry risk concentrates on:

• generic fixed-dose combinations needing bioequivalence plus device or formulation-related comparability
• process and impurity control that must match originator performance targets
• patent-for-patent litigation that can block manufacturing or distribution even if the FDA approval is granted

Common risk vectors

• delayed or incomplete method transfer at scale
• failure to control impurities below specification during scale-up
• stability failures that force changes in packaging systems or solid-form controls

Which FDA regulatory pathways affect suppliers for cedazuridine/decitabine?

Short answer: For oral combination products, generic entrants usually pursue ANDA pathways; lifecycle changes may use CBE-30/CBE-0 or supplemental NDA routes. Supplier selection is constrained by whether the product can be approved with an acceptable reference and comparability package.

Regulatory data packages that drive qualification

• bioequivalence study reports
• dissolution profiles and bridging data
• stability data for the specific packaging configuration

What formulations are protected for cedazuridine/decitabine, and how does that impact sourcing?

Short answer: Formulation protection for nucleoside analog combination tablets typically targets excipients, blend properties, tablet performance, and dissolution. Supplier qualification is affected when:

• excipient selection is constrained by proprietary formulation claims
• dissolution is tightly linked to the manufacturing process and particle size distribution

Where suppliers get caught

• switching excipients without a full comparability dossier
• changes in granulation/compression parameters that shift dissolution kinetics
• impurity profile drift from a different API grade or different solid form

What manufacturing/IP barriers stop non-incumbent suppliers from qualifying?

Short answer: Barriers usually come from a combination of:

• patent-protected processes
• tight impurity specifications
• regulatory expectation for equivalence to originator performance

Typical manufacturing barrier categories

• API crystallization step controls (solid form and impurity carryover)
• purification and chromatography method claims
• polymorph/hydrate transitions during scale-up or packaging storage
• tablet manufacturing controls linked to dissolution

How do cedazuridine and decitabine supplier options compare across geographies?

Short answer: Geography affects availability of nucleoside analogue expertise, DMF readiness, and compliance maturity. In practice:

• major API suppliers tend to be global with US/EU audit readiness
• tablet CMOs are more regionally concentrated but compete for commercial load once NDA-to-commercial readiness is demonstrated

Commercial selection criteria

• ability to support GMP audits within tight timelines
• scale-up track record for nucleoside analogs
• quality system maturity and deviations history
• analytical method capability for impurity profiling and stability prediction

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Key Takeaways

• Cedazuridine and decitabine sourcing is structured around DMF-backed nucleoside API supply and qualified solid-dose tablet CMOs.
• Supplier qualification is driven by impurity control, solid-form handling, dissolution performance, and patent-protected process and formulation routes.
• The biggest supply-chain shifts occur around Orange Book/patent milestones and exclusivity changes, which expand competition and reduce manufacturing/IP entry friction.

FAQs

1. How do API DMFs for cedazuridine and decitabine speed up supplier onboarding?
2. What impurity specifications usually determine whether a new decitabine API supplier can qualify?
3. How do tablet dissolution targets affect CMO selection for fixed-dose cedazuridine/decitabine products?
4. What role do quality agreements and audit readiness play in approving cedazuridine/decitabine suppliers?
5. How do patent settlements influence the timing of generic cedazuridine/decitabine manufacturing start dates?

References

1. Not provided.