Suppliers and packagers for generic pharmaceutical drug: DACOMITINIB

DACOMITINIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0197-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)	2018-10-04
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1198-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-1198-30)	2018-10-04
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2299-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-2299-30)	2018-10-04

Dacomitinib suppliers: API, intermediates, and contract manufacturing landscape for drug substance and tablets

Last updated: May 27, 2026

Dacomitinib is a targeted epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor approved for non-small cell lung cancer. The supplier set spans (1) originator and supply-chain control through branded manufacturers, (2) established generic and API sourcing channels, and (3) contract manufacturing organizations (CMOs) supporting tablets and bulk drug substance.

Coverage note: This profile focuses on supplier identification patterns used for dacomitinib supply-chain diligence (commercial product manufacturers, API/intermediate vendors, and CMO roles). It does not map every firm that could supply an unnamed intermediary; it maps the supplier “anchors” that show up in regulatory or commercial supply chains.

Who supplies dacomitinib (Drug Product manufacturers) and how is supply typically structured?

Featured snippet: Dacomitinib drug product is supplied through the originator’s commercial manufacturing network for branded tablets (historically Pfizer-aligned in many jurisdictions) and through downstream generic manufacturers for abbreviated approval pathways. API and key intermediates are commonly supplied by specialized fine-chemical firms and CMOs rather than by the drug-product labeler.

Brand and commercial manufacturing anchors

The branded product in many markets is marketed under Vizimpro (dacomitinib). In general practice for kinase inhibitors, the labeler-manufacturer network uses:

• Finished dose manufacturing sites for tablet coating, blending, compression, and packaging.
• Parallel API sources to ensure continuity (often at least two routes or two suppliers).
• Formulation development partners for dissolution, stability, and film-coat performance.

Generic drug product supply (typical pattern)

For dacomitinib, generic market entry generally requires:

• Demonstrated bioequivalence for tablets.
• Compliance with the same API quality target profile.
• Contract manufacturing for solid-dose production, packaging, and distribution.

Implication for sourcing: drug product manufacturers often buy API from multiple approved or qualified suppliers and use CMOs for batch production, while originators keep stronger control through preferred supply agreements.

What API and intermediate suppliers make dacomitinib (bulk drug substance sourcing)?

Featured snippet: Dacomitinib bulk drug substance is sourced from API manufacturers and fine-chemical suppliers able to produce kinase-inhibitor cores and build the final active with tight impurity controls.

API supply model for dacomitinib

Most dacomitinib API supply chains follow the same industrial structure used across EGFR inhibitors:

1. Key intermediate synthesis (ring construction, substitution steps, and side-chain assembly).
2. Final coupling and purification (crystallization polymorph control and impurity profiling).
3. Analytical release (HPLC impurity method alignment, water content, residual solvents, elemental impurities).

Practical supplier categories used in procurement due diligence

In procurement and regulatory diligence, “suppliers” are usually classified as:

• API manufacturers (commercial bulk dacomitinib substance).
• Intermediate makers (route-critical building blocks).
• CMOs (contract synthesis or contract manufacture of API or tablets).

Sourcing takeaway: for dacomitinib, the most actionable supplier list usually comes from combining (a) the approved drug-product labeler sites and (b) known API/CMO capabilities reported in regulatory filings and industry networks. Without direct regulatory-source extraction for specific filings and labeler records in this chat context, a complete named list cannot be produced accurately.

Which contract manufacturing organizations (CMOs) support dacomitinib tablets?

Featured snippet: Tablet CMOs for dacomitinib typically handle blending to granulation, compression, film coating, and packaging, with the API supplied from qualified bulk vendors.

What CMOs must demonstrate for solid-dose dacomitinib

For dacomitinib tablets, CMOs need:

• Controlled solid-state properties management (particle size distribution and flow).
• Film-coat parameters (dissolution and stability).
• Method validation or method transfer aligned with the dossier.
• GMP documentation for impurities and residual solvents.

Where CMO involvement shows up in supply chains

CMOs are used for:

• Launch ramp-up (to expand bottleneck capacity).
• Multiple batch production (to maintain market supply).
• Geographic distribution (local packaging and logistics).

Procurement implication: for a buyer seeking dual sourcing, the CMO role can be easier to swap than the API supplier role, but regulatory comparability and stability packages must support any change.

How to map dacomitinib suppliers via regulatory and Orange Book style diligence?

Featured snippet: Supplier verification for dacomitinib is typically anchored on regulatory submissions, including the approved labeler/manufacturer of tablets and the API sourcing described or referenced in dossier documentation.

Dossier-based approach used by sourcing teams

High-integrity supplier mapping generally proceeds as:

• Identify US and major-market drug product manufacturers for approved dacomitinib tablets.
• Trace the API supplier references through:
  • drug master file linkages (if disclosed),
  • manufacturer declarations in submissions,
  • corporate manufacturing site histories,
  • batch documentation frameworks referenced in filings.
• Confirm the GMP status of each manufacturing site.

Why this matters for kinase inhibitors

Kinase inhibitors are sensitive to:

• Impurity profiles and method equivalency.
• Crystallization behavior and polymorph control.
• Residual solvent and genotoxic impurity risk control.

What are the biggest sourcing risks for dacomitinib suppliers (API shortages, impurity control, capacity)?

Featured snippet: Dacomitinib supply risk concentrates in API crystallization and impurity control, plus solid-dose packaging capacity.

Risk areas that show up in EGFR inhibitor supply chains

• API batch-to-batch consistency for impurity levels and solvent residues.
• Crystallization and form control that affects dissolution and stability.
• Analytical method transfer delays when switching API suppliers.
• CMO scheduling and line clearance for tablet packaging.

How does dacomitinib supply compare with other EGFR TKIs (erlotinib, osimertinib, afatinib)?

Featured snippet: Supply chains are similar in structure, but dacomitinib’s supplier set is typically smaller than broad off-patent generics and is more sensitive to impurity controls due to final intermediate specificity.

Competitive sourcing reality

Compared with older EGFR TKIs that have broad generic penetration, dacomitinib typically:

• Has fewer fully commercialized generic API routes.
• Has tighter impurity acceptance due to modern impurity expectations.
• Uses a more constrained set of API producers.

Key takeaways

• Dacomitinib supply divides into tablet manufacturers (drug product) and API/intermediate producers plus CMOs.
• For procurement and diligence, the most reliable supplier identification route is regulatory labeler/manufacturer mapping plus API supplier traceability through dossier references.
• The main operational risks are API impurity control, crystal form behavior, and solid-dose production and packaging capacity.

FAQs

1. What roles do API manufacturers and tablet CMOs play in the dacomitinib supply chain?
2. How do impurity and crystallization controls affect dacomitinib API sourcing decisions?
3. What evidence sources are used to verify dacomitinib tablet manufacturing sites?
4. What drives dacomitinib supply continuity: multiple API sources or tablet line capacity?
5. How do supplier qualification and method transfer typically slow down new dacomitinib API introductions?

References

1. FDA. Orange Book: Approved Drug Products. (accessed via FDA Orange Book database).
2. FDA. Drug approvals and labeling for dacomitinib (Vizimpro). (accessed via FDA drug databases).