Suppliers and packagers for NERLYNX

NERLYNX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051	NDA	Puma Biotechnology, Inc.	70437-240-18	1 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE	2017-07-17
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051	NDA	Puma Biotechnology, Inc.	70437-240-26	1 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLE	2017-07-17
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051	NDA	Puma Biotechnology, Inc.	70437-240-33	1 BOTTLE in 1 BOX (70437-240-33) / 133 TABLET in 1 BOTTLE	2017-07-17

NERLYNX (neratinib): Who supplies it, who makes it, and what manufacturers control the supply chain

Last updated: May 25, 2026

NERLYNX is supplied in the U.S. by Puma Biotechnology, Inc. as the listed applicant/sponsor for FDA submissions and the Orange Book NDA holder (NDA 205188). Commercial supply is typically executed through contract manufacturing and packaging partners controlled by Puma’s quality system and specifications, with drug substance and drug product sourced from qualified external manufacturers.

The public record that can be used to identify specific “suppliers” (API manufacturer, finished-dose manufacturer, and packaging site operators) is the FDA Drug Product/Labeler and Orange Book ecosystem and, where available, the FDA label manufacturing information. In the sources available here, the NDA label and Orange Book listing support Puma as the responsible company for the product application, but they do not provide a complete, sponsor-verified list of named API and drug-product manufacturing-site suppliers in a way that can be reproduced accurately.

What companies supply NERLYNX (neratinib) in the U.S.?

Direct answer: Puma Biotechnology, Inc. supplies NERLYNX as NDA holder and labeler in the U.S. (NDA 205188). The named manufacturing-site “supplier” details require label/CMC site disclosures that are not fully available in the sources used in this record.

What does the Orange Book list for NERLYNX?

Direct answer: Orange Book identifies the NDA holder and patent linkages for NERLYNX; it also provides an anchor for the marketed product description (strength, dosage form) under NDA 205188.

Key implications for “supplier” analysis:

• Orange Book confirms who controls the NDA and thus who is responsible for regulatory compliance of the branded supply.
• Orange Book does not reliably enumerate every external API supplier; that detail generally sits in CMC modules and label “Manufactured for/By” statements.

What does the FDA label indicate about suppliers?

Direct answer: FDA labels typically identify “manufactured for” or “manufactured by” entities for the drug product and sometimes the packaging. In the sources accessed for this record, the NDA holder is clear, while the full named contract manufacturing vendor chain cannot be validated sufficiently to list specific site operators without risking inaccuracies.

Who makes the active ingredient neratinib used in NERLYNX?

Direct answer: The active ingredient is neratinib (a small-molecule tyrosine kinase inhibitor). The API supplier(s) are generally disclosed in CMC and/or label manufacturing statements, but the specific named API “supplier” entities are not enumerated in the cited material available here.

Is neratinib supplied by a single API vendor or multiple sites?

Direct answer: Branded oncology small molecules frequently use multiple qualified API sources for continuity of supply, but a definitive vendor count and names for neratinib are not validated in the sources used for this record.

Which contract manufacturers and packaging suppliers are tied to NERLYNX?

Direct answer: NERLYNX supply typically involves contract manufacturing for dosage form creation and packaging under Puma’s quality system. However, a verified vendor list for contract manufacturing and packaging sites is not fully extractable from the accessible cited sources in this record.

What to expect in vendor disclosures for small-molecule branded oncology drugs?

• API manufacturing often occurs at one or more qualified small-molecule synthesis sites.
• Drug product manufacturing typically includes granulation or milling (if applicable), blending, compression/capsule filling, coating (if applicable), and packaging under cGMP.
• Labels often name one or more responsible manufacturers using “Manufactured by/for” language, which is where the “supplier” chain becomes public.

In this record, Puma’s role is supported, but the specific vendor chain is not.

How can NERLYNX “supplier” exposure change during patent or exclusivity shifts?

Direct answer: Supplier risk for branded small molecules rises when the market moves toward generic/authorized alternatives that can fragment sourcing and introduce new API/drug product sites. For NERLYNX, supplier continuity depends on Puma’s validated manufacturing networks rather than patent status alone.

Does supplier identity affect generic entry risk?

Direct answer: Yes. For generics and label challengers, supplier readiness affects:

• API availability,
• control strategy transfers,
• ability to meet dissolution and impurity specs,
• packaging configuration equivalence.

But the specific suppliers needed to assess that risk are not available in the sources used here.

NERLYNX supply chain stakeholders: roles that matter

Direct answer: Even without naming each contract vendor, the stakeholder structure for NERLYNX is predictable:

1. NDA holder/brand owner: Puma Biotechnology, Inc. (responsible for regulatory submissions and marketed product quality).
2. Drug substance (API) supplier: qualified manufacturing site(s) producing neratinib API under cGMP and controlled specifications.
3. Drug product manufacturer: qualified site(s) producing the final neratinib dosage form (tablets or capsules depending on marketed configuration).
4. Packaging and labeling: packaging site(s) that apply final labeling, maintain traceability, and distribute through the U.S. channel.

What is the practical supplier list for business due diligence?

Direct answer: The only fully verifiable supplier entity from the accessible record is Puma Biotechnology, Inc. (NDA 205188). A complete list of named API and drug-product manufacturing vendors cannot be produced from the cited material used in this record without increasing the risk of factual error.

Key Takeaways

• Puma Biotechnology, Inc. is the U.S. NDA holder and labeler for NERLYNX (NDA 205188) and is the primary accountable “supplier” entity for regulatory purposes.
• The public, cited record used here does not support a complete, vendor-named chain for API suppliers, finished-dose contract manufacturers, and packaging sites.
• For licensing, contracting, or supply-risk modeling, the next step in a production-grade workflow is vendor confirmation from the NERLYNX label “Manufactured for/By” section and NDA CMC-linked manufacturing disclosures, mapped to cGMP site registrations.

FAQs

1) Who is listed as the manufacturer or labeler for NERLYNX in the FDA records?
Puma Biotechnology, Inc. is the NDA holder and labeler associated with NDA 205188.

2) What is the Orange Book NDA number for NERLYNX?
NERLYNX is associated with NDA 205188.

3) Are NERLYNX API suppliers listed in the Orange Book?
Orange Book primarily lists patents and NDA-level information. API supplier identities are not reliably enumerated there.

4) What document best identifies contract manufacturing and packaging suppliers for NERLYNX?
The FDA label “Manufactured for/By” section and related manufacturing statements in the submission record.

5) Does supplier identity change when market exclusivity ends?
Often, yes, because continuity of supply can shift to additional qualified sites, but specific changes for NERLYNX depend on Puma’s validated manufacturing network.

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References

1. U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. NDA 205188.
2. FDA. NERLYNX (neratinib) FDA label and prescribing information for NDA 205188.