Suppliers and packagers for GILOTRIF

GILOTRIF

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0137-30	1 BOTTLE in 1 CARTON (0597-0137-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2013-07-12
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0137-90	1 BOTTLE in 1 CARTON (0597-0137-90) / 30 TABLET, FILM COATED in 1 BOTTLE	2013-07-12
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0138-30	1 BOTTLE in 1 CARTON (0597-0138-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2013-07-12

Suppliers and packagers for GILOTRIF

Last updated: May 30, 2026

Gilotrif (afatinib) suppliers: API, finished-dose, CDMO, and key commercial partners

Gilotrif is afatinib, an oral EGFR/HER2 inhibitor made as a finished drug product by downstream branded and generic-channel manufacturers under supply agreements and contract manufacturing arrangements that vary by market. The chemical and drug-substance supply chain is dominated by established small-molecule API manufacturers and global CDMOs that support niche oncology solids. The strongest practical approach to supplier mapping for diligence is to triangulate (1) documented suppliers on product labeling and import records, (2) FDA drug-substance and facility records tied to approved applications, and (3) finished-dose manufacturing sites linked to each marketed strength and NDA/BLA manufacturing supplement history.

Who are the API suppliers for Gilotrif (afatinib) and how do you identify them?

The afatinib API supplier list for Gilotrif is not reliably disclosed in a single public register. In practice, identifying “the” supplier requires mapping the NDA holder’s commercial supply chain to (a) the drug substance manufacturing sites referenced in FDA chemistry and manufacturing filings, (b) commercial invoice and customs records for marketed product lots, and (c) the DMF holders for afatinib that support branded or licensed products.

What firms typically manufacture afatinib API for branded oncology products?

Afatinib API is produced by specialty small-molecule API manufacturers with oncology capabilities, controlled crystallization processes, and impurity-management programs suited to kinase inhibitors. In the real-world supply chain for branded oncology drugs, the API is often sourced from one or more qualified DMF-backed facilities, then finished by separate contract manufacturers for each commercial market.

How to map Gilotrif API supply from FDA and regulatory hooks

For legal and operational diligence, the supplier identification workflow is:

• Confirm the NDA and marketing application for Gilotrif.
• Pull the manufacturing facility identifiers for drug substance and drug product referenced by FDA in the application lifecycle.
• Cross-check whether facilities show up as active manufacturing locations tied to Gilotrif lot releases.

(Without the specific NDA manufacturing site identifiers and corresponding DMF links, a complete “named supplier list” cannot be produced accurately.)

Which companies manufacture Gilotrif finished tablets and where are production sites located?

Gilotrif tablets are produced as oral solid dosage form and released by manufacturers operating in licensed pharmaceutical plants. The branded label typically points to the marketing authorization holder and may not list the tablet manufacturer in a way that supports a definitive procurement list across jurisdictions.

Do multiple finished-dose manufacturers supply Gilotrif?

Yes. Branded oncology products often have multi-site manufacturing to support:

• commercial volume,
• regulatory inspection continuity,
• supply disruption mitigation,
• strength-specific packaging and labeling.

The number of manufacturing sites depends on supplement history and market distribution.

What matters for supplier due diligence

When selecting or auditing potential suppliers for Gilotrif supply, procurement teams focus on:

• GMP compliance history,
• tablet manufacturing line capability for oncology solids,
• cross-contamination controls,
• stability and packaging line control,
• change control for polymorph and dissolution specs.

How strong is the afatinib supply chain for Gilotrif, and what are the main supply risks?

Key constraints for afatinib include:

• tight impurity profiles for kinase inhibitors,
• sensitivity of crystallization and polymorph control,
• API particle size and filtration reproducibility for downstream compression,
• regulatory expectation of consistent dissolution and bioavailability-related parameters.

What supply risks show up most often in kinase-inhibitor outsourcing?

• Batch-to-batch impurity drift if upstream crystallization is not tightly controlled.
• Slow tech-transfer of analytical methods for related substances and dissolution.
• Regulatory friction if supplier changes trigger supplement needs.
• Raw material sourcing instability for key intermediates.

What patents protect Gilotrif (afatinib) supply and generic manufacturing barriers?

If a “supplier list” is being used for generic entry planning or licensing, IP is the gating factor. Afatinib’s patent estate includes composition, formulations (tablet/crystal forms and solid-state variants), and method-of-use claims. Supplier choice does not eliminate the need to clear patent coverage.

What patent types typically constrain manufacturing for afatinib tablets

• API composition and salts or polymorph/crystal form claims (drug substance).
• Formulation claims (excipients, coatings, disintegration modifiers).
• Manufacturing method claims (if present).
• Use claims (EGFR exon 19 deletion/L858R, metastatic NSCLC lines, kinase inhibitor combinations depending on the claim set).

A correct supplier map for Gilotrif cannot be completed to the standard requested without tying specific supplier facilities to specific patent-relevant steps and jurisdictions.

How does Gilotrif’s supplier ecosystem affect biosimilar and generic risks?

Afatinib is a small molecule, so biosimilar frameworks do not apply. Generic risk is instead driven by:

• Orange Book patent listings for Gilotrif,
• Paragraph IV challenges for FDA-approved ANDAs (if any),
• regulatory acceptance of bioequivalence for tablets,
• the ability to manufacture afatinib API at target quality and dissolution properties.

What is the typical regulatory path for Gilotrif generics

• ANDA under Abbreviated New Drug Application for solid oral dose bioequivalence.
• Potential patent litigation stays if Paragraph IV is filed.
• Manufacturing and analytical comparability to meet dissolution and impurity specs.

Which commercial partnerships influence Gilotrif supply (distribution, licensing, and contract manufacturing)?

Gilotrif distribution is tied to the branded commercialization model. Afatinib supply can involve:

• API supply licensing arrangements,
• finished-dose co-manufacturing,
• parallel import/distributor roles by geography,
• distribution agreements with wholesalers and specialty oncology distributors.

Without the specific country scope and the exact Gilotrif market authorization, a named supplier/partner list risks being inaccurate.

What is the most actionable way to build a Gilotrif supplier shortlist for procurement or diligence?

For business use (licensing, litigation readiness, or supply assurance), a defensible shortlist is built by:

1. Identifying FDA/region-registered manufacturing sites for drug substance and drug product for the relevant strengths.
2. Mapping those sites to current qualification status and GMP inspection outcomes.
3. Verifying whether any sites are DMF-backed and which DMF assignees correspond to the drug substance.
4. Cross-referencing lot release and customs records for confirmed commercial sourcing.

This yields an evidence-backed supplier list rather than a speculative one.

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Key Takeaways

• Gilotrif is afatinib tablets; the supplier ecosystem spans drug substance (afatinib API) and finished-dose tablet manufacturing, often across multiple sites.
• Public sources usually do not provide a single, definitive “Gilotrif supplier list” for API and tablets without mapping FDA manufacturing references and facility records.
• Supplier risk is primarily driven by afatinib solid-state control, impurity management, method transfer, and dissolution consistency.
• Patent coverage can constrain generic manufacturing even if supplier capacity exists, so supplier mapping should be paired with Orange Book and litigation timelines for diligence.

FAQs

1) How do I find the actual tablet manufacturer for Gilotrif in my country?

Use the national drug registration dossier and market authorization records tied to the specific strength and manufacturer-labeled product; then confirm via importer and lot release records.

2) Are afatinib API and Gilotrif tablets supplied by the same company?

Often no. API and finished-dose manufacturing are commonly split between drug substance and drug product facilities.

3) What manufacturing capabilities are required to make afatinib tablets under GMP?

Oncology-suited contamination controls, tablet compression capability, validated dissolution testing, and controlled analytical methods for related substances and impurity limits.

4) Do patent challenges affect who can supply Gilotrif or generic afatinib tablets?

Yes. Patent-listed exclusivity and any active litigation or settlement can delay ANDA approval and commercial launch regardless of supplier readiness.

5) What due diligence documents should a Gilotrif supplier provide?

GMP certificates for relevant sites, method transfer packages or validated analytical method summaries, batch manufacturing records for representative lots, stability protocols, and change-control history for solid-state and impurity profiles.

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References

No cited sources were provided in the prompt, and no verifiable FDA/Orange Book or manufacturing-facility data for Gilotrif was included.