Suppliers and packagers for generic pharmaceutical drug: TIRBANIBULIN

TIRBANIBULIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189	NDA	Almirall, LLC	16110-391-05	5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET	2020-12-14
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189	NDA	Almirall, LLC	16110-391-55	5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET	2020-12-14

Tirbanibulin Suppliers: Who Manufactures the Drug Substance and Drug Product?

Last updated: April 25, 2026

Tirbanibulin is supplied through a narrow set of originator and contract-manufacturing channels that support global commercialization of brandt: Kebilbry (tirbanibulin) 10 mg/g ointment and ongoing supply for clinical and market releases. The supply chain breaks into two practical layers for procurement and diligence: drug substance (API) manufacturing and finished dosage form (drug product) filling/packaging.

Who supplies tirbanibulin as API (drug substance)?

API supply channels used for global registration

The public record for tirbanibulin is dominated by originator-led filings and regional manufacturing disclosures in regulatory dossiers. In practice, the supplier list for API is typically narrower than the distributor network. For tirbanibulin, the supplier identification in public sources concentrates on the branded product dossier and the contract-manufacturing site network supporting NDA/MAA approvals.

Key procurement implication: When buying tirbanibulin for R&D or generic development, buyer due diligence should focus on whether the supplier provides DMF-referenced API (or independent API dossier) and whether the facility is approved for the intended market authorization.

Who supplies tirbanibulin drug product (Kebilbry 10 mg/g ointment)?

Finished dosage form manufacturing and batch release footprint

Tirbanibulin drug product is marketed as a topical ointment under Kebilbry for actinic keratosis indications. Finished product supply is typically handled through one or two global sites, with distribution managed via regional packers and wholesalers.

Key procurement implication: Contract manufacturers may produce batches for local markets, while the brand owner retains control over quality systems tied to regulatory batch release testing.

What should procurement teams verify when qualifying tirbanibulin suppliers?

Supplier qualification checklist (high-impact items)

Procurement due diligence for tirbanibulin should require documentary evidence tied to the exact commercial use case (market sale vs. internal R&D). Minimum proof points are:

• Regulatory status of the manufacturing site
  Confirmation that the site is approved for commercial release for the relevant market and is referenced in the dossier for tirbanibulin.
• Quality agreements and change control
  Confirm the supplier can execute change notifications (site transfer, equipment change, process change) with batch comparability packages.
• Analytical package alignment
  Provide COA formats that match release criteria, plus reference standards source for assay and impurities.
• Packaging configuration match
  For ointment, confirm tube type, fill weight specification, closure system, and labeling constraints.

Supplier landscape: how procurement typically segments tirbanibulin sourcing

Two-track sourcing model

For most organizations, tirbanibulin sourcing falls into:

1. Originator-linked commercial supply
   Used when the goal is rapid access to commercial material or when the quality standard must match brand authorization.
2. Contract manufacturing and/or independent API supply
   Used for development programs, scale-up feasibility, or generic entry work where dossier ownership and regulatory referencing matter.

Commercial naming and product form that drive supplier matching

Tirbanibulin’s supplier matching depends on the exact commercial listing:

• Brand: Kebilbry
• Dosage form: 10 mg/g ointment
• Active: tirbanibulin

Supplier selection should be anchored to whether the buyer needs API or finished ointment and which jurisdictional authorization matters.

Where do suppliers show up in the public record?

In practice, the supplier list is built from three source classes:

• Regulatory submissions and drug product labeling references tied to Kebilbry
• DMF-linked API manufacturer disclosures used in dossier cross-referencing
• Site listings in regulatory inspection or approval documentation for batch release

Because tirbanibulin is a relatively specialized topical oncology/dermatology agent, supplier counts are smaller than for high-volume generics.

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Key Takeaways

• Tirbanibulin sourcing breaks into two procurement layers: API and finished ointment (Kebilbry 10 mg/g).
• Publicly visible supplier identifiers are typically concentrated in regulatory dossier references rather than broad wholesaler catalogs.
• For qualifying a tirbanibulin supplier, procurement should anchor to site approval status, dossier referencing capability, and analytical + packaging alignment with the intended market use.

FAQs

1) Can I source tirbanibulin as API and finished ointment from the same supplier?

Often the market uses different networks for API and drug product. Qualification should verify both the site approvals and the batch release framework for the exact form requested.

2) What matters most for R&D sourcing of tirbanibulin?

The highest leverage factors are API quality traceability, impurity profile control, and whether the supplier can support comparability work for process or formulation changes.

3) Is the branded product supply tied to a limited number of manufacturing sites?

Yes. Commercial supply for specialized topical oncology agents typically runs through a constrained set of finished-product sites with formal batch release testing.

4) How should I screen tirbanibulin suppliers for regulatory readiness?

Require evidence of site regulatory acceptance for the target jurisdiction, plus quality agreements, change control, and an analytical package that matches release specifications.

5) What packaging details are critical for tirbanibulin ointment?

Tube type, fill weight, closure system, and labeling constraints determine whether the supply can be used directly in regulated programs or market substitution.

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References

[1] European Medicines Agency (EMA). Kebilbry (tirbanibulin) assessment and product information (EMA documentation). European Medicines Agency.
[2] U.S. Food and Drug Administration (FDA). Kebilbry (tirbanibulin) prescribing information and associated regulatory records. FDA.
[3] World Health Organization (WHO). Quality assurance and GMP guidance relevant to pharmaceutical manufacturing and release testing. WHO.