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

Suppliers for the Pharmaceutical Drug: Tirbanibulin

Last updated: July 29, 2025

Introduction

Tirbanibulin is a topical anti-cancer agent developed for the treatment of actinic keratosis, a common precancerous skin condition. It functions as a microtubule inhibitor, disrupting cell division in abnormal keratinocytes. Since gaining approval from regulatory agencies such as the U.S. Food and Drug Administration (FDA), Tirbanibulin has garnered attention for its targeted mechanism of action and clinical efficacy. The supply chain for Tirbanibulin encompasses a limited but strategically important set of pharmaceutical manufacturers, bulk ingredient suppliers, and formulation specialists. This report provides a comprehensive overview of the current suppliers involved in the production and distribution of Tirbanibulin.

Manufacturers of Tirbanibulin

1. Oncternal Therapeutics

Oncternal Therapeutics, a biotechnology company based in the United States, developed Tirbanibulin (also marketed as "Kowliga"). The company holds the patent rights for Tirbanibulin's synthesis, formulation, and commercialization. Oncternal's manufacturing facilities are strategically located to oversee the production process, including active pharmaceutical ingredient (API) synthesis, formulation, and final packaging.

2. CordenPharma International

CordenPharma, a Contract Development and Manufacturing Organization (CDMO), plays a critical role in the supply chain for Tirbanibulin. They provide services including API manufacturing, formulation development, and stability testing. CordenPharma's facilities are cGMP-compliant and located primarily in Europe and the United States, serving as an essential supplier for on-demand production.

3. Dr. Reddy’s Laboratories

While primarily known as a major pharmaceutical developer, Dr. Reddy’s Laboratories has engaged in early-stage clinical manufacturing contracts for Tirbanibulin. Potentially, they could serve as a secondary supplier or partner, especially in markets outside of the U.S.

4. Other Potential OEMs and Suppliers

Given the novelty of Tirbanibulin, multiple pharmaceutical manufacturers worldwide are exploring the synthesis of its API. Several Asian countries, particularly India and China, are known for producing similar intermediates and APIs, although specific API production for Tirbanibulin remains limited and mostly proprietary.

API Suppliers for Tirbanibulin

1. Specialized API Manufacturers

The synthesis of Tirbanibulin's API involves complex chemical processes requiring high precision and quality control. Currently, only a handful of specialized API manufacturers possess the technical expertise to produce Tirbanibulin’s active compound:

• CordenPharma: As part of their custom synthesis services, CordenPharma potentially supplies API bulk material under strict confidentiality agreements.

• Hospital-based or Contract API Synthesis Labs: Several niche API manufacturers in Europe and Asia specialize in microtubule inhibitor compounds, which could include Tirbanibulin, under contract manufacturing arrangements.

2. Raw Material and Intermediate Suppliers

Critical intermediates used in the synthesis of Tirbanibulin are supplied by high-grade chemical intermediate manufacturers. These companies produce key precursors required for synthesis, such as halogenated aromatic compounds and other heterocyclic intermediates. Notably:

• Hubei Shuangya Chemical Co., Ltd. (China): Known for producing aromatic intermediates.
• BASF and LANXESS (Europe): Major suppliers of chemical intermediates for pharmaceutical synthesis.

However, the step-specific details for Tirbanibulin's synthesis are proprietary, limiting full public disclosure.

Formulation and Final Product Manufacturing

1. Contract Manufacturing Organizations (CMOs)

The finished product, Tirbanibulin topical ointment, is often produced by CMOs specializing in dermatological formulations:

• Catalent Pharma Solutions: Extensive expertise in topical formulations and sterile manufacturing.
• Recipharm: Responsible for late-stage formulation and packaging, guaranteeing stability and bioavailability.

2. Packaging and Distribution

Packaging involves specialized pharmaceutical blister packs and tubes, supplied by companies such as Berry Global and Gerresheimer, renowned for their sterile packaging solutions.

Regulatory and Supply Chain Considerations

The tight manufacturing requirements for Tirbanibulin restrict the pool of qualified suppliers. Regulatory agencies require consistent quality, batch-to-batch uniformity, and traceability, which narrows sourcing options, especially for the API. Additionally, stockpiling and supply chain robustness are critical given Tirbanibulin’s relatively recent market entry.

Future Supply Chain Trends

• Vertical Integration: Companies may move toward vertical integration of synthesis, formulation, and packaging to mitigate risks.
• Emerging Markets: Increased manufacturing capacity in India and China could diversify sources of APIs and intermediates.
• Sustainability: Suppliers are under pressure to adopt greener synthesis pathways, potentially affecting AP manufacturing.

Conclusion

The supply chain for Tirbanibulin comprises a limited number of specialized manufacturers and suppliers, primarily dominated by Oncternal Therapeutics and several high-quality CDMOs such as CordenPharma. Raw material suppliers, intermediates manufacturers, and formulation specialists form the backbone of this niche pharmaceutical product. Given the proprietary nature of the synthesis, tracking specific API suppliers remains challenging, but future market dynamics suggest expanding manufacturing capacity in Asia and greater vertical integration.

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Key Takeaways

• Limited Supplier Base: Tirbanibulin’s production involves highly specialized manufacturers, constraining supply chain diversity.
• Strategic Partnerships: Main players include biotechnology firms owning patent rights and CDMOs providing manufacturing and formulation services.
• Regulatory Standards: Meeting cGMP standards is crucial, limiting suitable API manufacturers.
• Supply Chain Risks: Concentration of manufacturing locations heightens supply risks; diversification is likely in the future.
• Market Expansion: Asia-based API manufacturers may increasingly participate, driven by cost efficiencies and capacity expansion.

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FAQs

Q1: Who are the primary manufacturers of Tirbanibulin's API?
A1: Currently, specialized API synthesis for Tirbanibulin is mainly handled by contract manufacturing organizations such as CordenPharma, with other niche suppliers potentially involved under confidentiality agreements.

Q2: Can new suppliers enter the Tirbanibulin supply chain?
A2: Yes, but entry is limited by stringent quality requirements, proprietary synthesis pathways, and regulatory compliance, making it challenging for new manufacturers to qualify.

Q3: How does the supply chain for Tirbanibulin compare to other dermatological drugs?
A3: It is more constrained due to its novelty, complex synthesis, and narrower manufacturing base compared to well-established dermatological drugs with extensive global manufacturing networks.

Q4: Are there risks associated with Tirbanibulin’s supply chain?
A4: Yes, risks include supply disruptions from concentration of manufacturing sites, regulatory hurdles, and intellectual property constraints that may limit sourcing options.

Q5: What emerging trends could impact Tirbanibulin’s supply chain?
A5: Increasing localization of API manufacturing in Asia, vertical integration by pharmaceutical companies, and the adoption of sustainable synthesis methods are noteworthy trends.

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References

1. FDA Approval Announcement for Tirbanibulin [1].
2. CordenPharma Official Website [2].
3. Oncternal Therapeutics Corporate Information [3].

(Note: Actual sources and citations are to be verified for accuracy when compiling official reports.)