Suppliers and packagers for INLYTA

INLYTA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0145-01	180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0151-11	60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	U.S. Pharmaceuticals	63539-026-01	90 TABLET, FILM COATED in 1 BOTTLE (63539-026-01)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	U.S. Pharmaceuticals	63539-044-02	30 TABLET, FILM COATED in 1 BOTTLE (63539-044-02)	2012-01-27

Suppliers and packagers for INLYTA

Last updated: June 1, 2026

INLYTA (axitinib) suppliers: API, contract manufacturing, and packaging sources by supply chain node

Inlyta’s commercial supply chain for axitinib is dominated by API manufacture and downstream contract manufacturing for oral tablets, with large-scale packaging/distribution routed through global pharma logistics networks. Public supplier discovery for Inlyta is fragmentary because many upstream sources are not fully disclosed in FDA submissions or on label-level materials, and commercial procurement often runs through qualified supplier lists under NDA.

Who supplies Inlyta (axitinib) tablets in the US market?

FDA label-level “Manufactured for” data

• Inlyta product labeling identifies the marketing authorization holder and the listed manufacturer(s) responsible for drug product manufacture and/or release. Those entities are the starting point for identifying qualified suppliers for oral tablet production.

Typical supply chain structure for an oral TKI

• Drug substance (API) suppliers: axitinib active ingredient manufacture, typically via multi-step heterocycle formation and final salt-form or free-base specifications depending on the drug substance definition used.
• Drug product (tablets) manufacturers: formulation, granulation, compression, coating, and tablet packaging (bottles/blisters).
• Packaging and logistics providers: secondary packaging and cold-chain is not generally required for axitinib tablets, but temperature-controlled storage and GDP-compliant distribution are common.

What companies are listed as Inlyta tablet manufacturers on the label?

Where the label points

• In the US, the current US PI (prescribing information) and carton/label “Manufactured for” and “Manufactured by” statements generally name the drug product manufacturer.
• Inlyta’s US brand is marketed by Pfizer Labs in the US (marketing authorization/label role), while manufacturing is performed by one or more contracted or corporate manufacturing sites.

How to use this for supplier mapping

• Identify the named “manufacturer” entity on the label.
• Trace that entity’s manufacturing site to:
  • finished dose manufacturing capabilities (oral solid dose),
  • quality system scope (sterility not required, but blend uniformity, dissolution, and tablet coat integrity are critical),
  • and the likelihood it uses qualified API sources rather than internal axitinib synthesis.

Which suppliers provide axitinib drug substance (API) for Inlyta?

API supplier identification approach

• For a targeted “who supplies axitinib,” there are three high-signal sources:
  1. Drug master file (DMF) references in FDA submissions for later generic entries (often traceable via Orange Book and FDA correspondence).
  2. Third-party litigation exhibits in axitinib IP or supply disputes (when entered into the public record).
  3. Contract manufacturing disclosures in product registrations outside the US (site licenses, MA dossiers, and compendial submissions).

Reality for public visibility

• Many axitinib API producers supply multiple clients and often do not disclose “Inlyta-only” status. The result is that “supplier for Inlyta” often resolves to “qualified supplier for axitinib drug substance used across multiple products.”

How do Inlyta suppliers handle contract manufacturing for oral solid dose?

Oral tablet manufacturing nodes

• Blend uniformity and dose content: axitinib tablets require tight assay and uniformity because it is a potent small-molecule kinase inhibitor.
• Film coating: tablet coating process parameters materially affect dissolution and appearance; suppliers typically have established coating lines and in-process controls.
• Moisture/oxygen controls: long-term stability depends on packaging design (bottle desiccant or blister laminate choice) and humidity control in manufacturing.

What this means for procurement

• The drug product manufacturer’s qualification package (process validation, ICH stability data, dissolution specification performance) typically becomes the gating item for any new entrant or supply switch.

What are the packaging and distribution suppliers for Inlyta?

Packaging supplier role

• Packaging is frequently handled by:
  • the drug product manufacturer under a primary label authorization, or
  • a secondary packaging contract site that receives bulk tablets and performs bottle/blister final packaging.

Distribution

• Inlyta distribution is typically routed via:
  • wholesaler networks with GDP and cold storage capabilities not generally required, but with temperature monitoring,
  • and specialty pharmacy channels because of TKI REMS-like monitoring practices (if applicable via institutional policy, not because Inlyta itself is a REMS program drug).

How many distinct supplier nodes exist for Inlyta (API, drug product, packaging)?

Supply chain mapping

• In practice, the node count is often:
  • 1 to 2 qualified axitinib API suppliers,
  • 1 to 2 drug product manufacturing sites,
  • 1 to 3 packaging/secondary packaging sites depending on lot strategy and regional demand.

Why multiple sites matter

• Oral on-market shortages are usually managed via:
  • parallel tablet manufacturing campaigns at multiple sites,
  • or inventory building using packaging site redundancy.

Which contract manufacturers can make axitinib tablets like Inlyta?

Capabilities relevant to Inlyta

• Oral solid dose formulation and manufacturing for potent small molecules:
  • containment and cleaning validation,
  • in-process control systems for granulation/compression,
  • validated dissolution and coating processes,
  • packaging validation for blister or HDPE bottles.

Named contract manufacturers

• Without a specific, currently-cited label or FDA listing for the exact Inlyta manufacturing sites and with no verified public supplier list for axitinib API, naming specific third-party CMO/CMG companies as “Inlyta suppliers” would be speculative. The reliable path remains the label “manufacturer” entities for drug product plus FDA-linked manufacturer identifiers for drug substance.

What patents or regulatory filings connect Inlyta manufacturing to supplier disclosure?

Why filings matter

• Supplier identity is sometimes indirectly revealed via:
  • ANDA/505(b)(2) chemistry/manufacturing documentation references,
  • DMF references (if a generic references a DMF for axitinib API),
  • and site-specific manufacturing section in FDA drug establishment listings.

Practical implication

• For supplier diligence, the highest-yield workstreams are:
  • mapping the drug product manufacturer from the label,
  • mapping FDA drug establishment registration entries for that product,
  • then triangulating API via DMF-linked references from generic submissions.

Inlyta supplier landscape vs typical axitinib generic supply chain

Brand-to-generic comparison

• Branded oncology TKIs often retain:
  • a small number of qualified API sources to stabilize cost and quality,
  • and one primary tablet manufacturing site plus a backup.
• Generic entrants must demonstrate:
  • API identity and impurity profile,
  • bioequivalence and dissolution match,
  • and their own manufacturing controls.

Supplier switching risk

• Any change in API supplier or tablet manufacturing site can require:
  • comparability protocols,
  • updated stability commitments,
  • and, where relevant, additional regulatory reporting.

Key takeaways

• Inlyta’s supply chain for axitinib involves three core supplier nodes: axitinib API production, finished-dose tablet manufacture, and secondary packaging.
• The most reliable public “supplier” starting point is the Inlyta US label “manufactured for/by” entities for drug product.
• Upstream axitinib API supplier identification is often obscured by DMF references and multi-client qualification, so “Inlyta-only” API attribution is not consistently public.
• Best-practice supplier diligence for Inlyta focuses on: label manufacturer mapping, FDA establishment entries, and DMF-linked API references from relevant FDA submissions.

FAQs

1. Is Inlyta manufactured in multiple US sites or only one?
2. Which DMFs are referenced for axitinib API in later generic filings?
3. Do Inlyta suppliers provide blister and bottle packaging, and who performs secondary packaging?
4. Can axitinib tablet CMOs handle potent small-molecule containment and validated cleaning?
5. What regulatory filings reveal changes in Inlyta manufacturing sites or packaging suppliers?

References

1. Pfizer Labs. INLYTA (axitinib) Prescribing Information / US label (current version). FDA/Drugs@FDA.
2. FDA. Drugs@FDA: INLYTA (axitinib).
3. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (INLYTA/axitinib).