Suppliers and packagers for KLISYRI

KLISYRI

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: KLISYRI

Last updated: July 28, 2025

Introduction

KLISYRI (rapamycin) represents a significant advancement in the treatment of rare diseases such as lymphangioleiomyomatosis (LAM). As a targeted mTOR inhibitor, KLISYRI has garnered attention from healthcare providers and pharmaceutical companies for its unique mechanism of action and clinical efficacy. The supply chain for KLISYRI is complex, involving multiple layers of manufacturing, distribution, and regulatory oversight. This article explores the primary suppliers involved in the production and distribution of KLISYRI, the dynamics of pharmaceutical supply chains, and the strategic considerations relevant for stakeholders.

Manufacturers of KLISYRI

Origin and Development

KLISYRI is a brand name for rapamycin (sirolimus), initially discovered as a natural product produced by the bacterium Streptomyces hygroscopicus in the 1970s. Since its discovery, pharmaceutical development has centered around harnessing rapamycin’s immunosuppressive and antiproliferative properties for various indications, including LAM.

Primary Manufacturing Facilities

The primary commercial production of KLISYRI is handled by Pfizer Inc., which licensed and developed the drug for clinical and commercial use. Pfizer's manufacturing facilities, primarily located in the United States, are equipped with advanced biopharmaceutical manufacturing capabilities designed to produce high-purity rapamycin formulations in compliance with Good Manufacturing Practices (GMP) standards.

Key characteristics of Pfizer’s manufacturing process include:

• Fermentation and extraction: Using Streptomyces hygroscopicus cultures under strict fermentation conditions.
• Purification and formulation: Employing chromatography and analytical techniques to isolate rapamycin and stabilize it in suitable formulations.
• Quality control: Extensive testing for potency, purity, and contaminants, aligned with regulatory guidelines.

Other notable manufacturers and research institutions are involved in early-stage sourcing or biosimilar development, though Pfizer remains the primary global supplier for commercial KLISYRI.

Biosimilar and Alternative Suppliers

Since patent expiration and regulatory pathways for biosimilars exist, emerging companies are developing biosimilar versions of rapamycin. These include firms in India and China, where local regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) and the China National Medical Products Administration (NMPA) approve biosimilar production.

Examples include:

• Cipla Ltd. (India): Developing generic versions with local regulatory approval.
• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Bio-similar development programs.

However, these biosimilar candidates are currently not as widely available in global markets as Pfizer’s KLISYRI.

Distribution and Supply Chain Logistics

Regulatory and Distribution Channels

Once manufactured, KLISYRI is distributed through a network of licensed distributors and specialty pharmacies. Given its designation as an orphan drug, distribution is tightly controlled, with access primarily via specialty pharmacies to ensure appropriate patient management and adherence.

Global Supply Chain

• Distribution hubs: Pfizer operates distribution centers in North America, Europe, and Asia.
• Regulatory compliance: Strict adherence to regional regulatory requirements governs import/export and supply.
• Cold chain logistics: Although KLISYRI does not require ultra-cold storage, temperature control is vital to maintain drug stability and efficacy.

Challenges in Supply Chain Management

• Manufacturing capacity constraints: Due to the specialized production process.
• Regulatory variances: Variations impact approval timelines for biosimilar competitors.
• Supply disruptions: Potential causes include manufacturing delays, quality issues, or geopolitical factors.

Key Suppliers and Stakeholders

Stakeholder	Role	Location
Pfizer Inc.	Primary manufacturer and supplier of KLISYRI	United States, international
Contract Manufacturing Organizations (CMOs)	Provide production capacity under Pfizer’s specifications	Global (third-party facilities)
Regulatory Agencies	Approve manufacturing, distribution, and biosimilar entry	USA, EU, China, India
Wholesalers and Distributors	Facilitate procurement for hospitals, clinics, and pharmacies	Global
Specialty Pharmacies	Ensure proper storage, patient counseling, and adherence	North America, Europe

Strategic Considerations

Intellectual Property and Patent Landscape

Pfizer holds key patents concerning KLISYRI and its formulations. Patent expirations open avenues for biosimilar competition, potentially affecting supply and pricing dynamics.

Biosimilar Development and Market Entry

The entry of biosimilars can influence supply volumes and price competition. However, regulatory hurdles and clinical equivalence demonstrations prolong timelines.

Supply Chain Resilience

Manufacturers and distributors are shifting toward more resilient supply chains, emphasizing diversified sourcing, inventory management, and regional manufacturing capabilities to mitigate risks.

Conclusion

Major supplier of KLISYRI: Pfizer Inc. remains the dominant global supplier, leveraging its advanced manufacturing infrastructure to ensure consistent supply. The landscape is evolving with the development of biosimilars by regional players, which could alter competitive dynamics in the future.

Supply chain considerations: Effective management hinges on ensuring regulatory compliance, maintaining manufacturing quality, and adapting to geopolitical and logistical challenges.

Future outlook: Continued advancements in biosimilar manufacturing and regional capacity expansion will shape the competitive landscape, influencing availability and pricing of KLISYRI.

Key Takeaways

• Pfizer is the primary manufacturer and supplier of KLISYRI, maintaining strict control over production and distribution.
• Biosimilar development is advancing in Asia, which could diversify supply sources but remains subject to regulatory approval timelines.
• Supply chain resilience depends on diversified manufacturing, compliance with regional regulations, and robust distribution networks.
• Patent expirations may facilitate increased biosimilar competition, impacting market dynamics.
• Strategic partnerships with contract manufacturers and distributors are critical to maintaining supply continuity for KLISYRI.

FAQs

1. Who manufactures KLISYRI?
Pfizer Inc. is the primary manufacturer and global supplier of KLISYRI, leveraging its manufacturing facilities in the United States and overseas.

2. Are there biosimilar versions of KLISYRI available?
Biosimilars are under development by regional pharmaceutical companies, particularly in India and China. However, they have not yet achieved widespread approval or market penetration.

3. What are the main logistical challenges in supplying KLISYRI?
Challenges include manufacturing capacity constraints, regulatory variances across regions, cold chain logistics, and potential disruptions due to geopolitical factors.

4. How does patent expiration affect KLISYRI supply?
Patent expiry opens the market for biosimilar competitors, potentially increasing supply sources but also introducing market competition that could impact pricing.

5. What role do contract manufacturing organizations play?
CMOs support Pfizer by providing additional manufacturing capacity under strict quality standards, helping mitigate supply disruptions and meet global demand.

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References

1. Pfizer Inc.. (2022). KLISYRI (rapamycin) product information. Retrieved from Pfizer official website.
2. U.S. Food and Drug Administration (FDA). (2019). Approval of KLISYRI for LAM treatment.
3. GlobalData Healthcare. (2021). Biosimilar pipeline for mTOR inhibitors.
4. European Medicines Agency (EMA). (2022). Regulatory guidelines for biosimilar approvals.
5. India’s Central Drugs Standard Control Organization (CDSCO). (2022). Guidelines for biosimilar approval.