Suppliers and packagers for generic pharmaceutical drug: PEMIGATINIB

PEMIGATINIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736	NDA	Incyte Corporation	50881-026-01	14 TABLET in 1 BOTTLE, PLASTIC (50881-026-01)	2020-04-17
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736	NDA	Incyte Corporation	50881-027-01	14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01)	2020-04-17
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736	NDA	Incyte Corporation	50881-028-01	14 TABLET in 1 BOTTLE, PLASTIC (50881-028-01)	2020-04-17

Suppliers for the Pharmaceutical Drug: PEMIGATINIB

Last updated: July 30, 2025

Introduction

Pemigatinib, marketed under the brand name Pemazyre, represents a significant advancement in targeted cancer therapies, particularly for intrahepatic cholangiocarcinoma and other solid tumors driven by fibroblast growth factor receptor (FGFR) alterations [1]. Developed by Molecular Partners and marketed by Incyte Corporation, pemigatinib exemplifies precision medicine, binding selectively to FGFR1, FGFR2, and FGFR3 kinases to inhibit tumor proliferation [2].

As the demand for targeted oncology treatments escalates, understanding the landscape of pemigatinib’s suppliers is critical for stakeholders encompassing healthcare providers, pharmaceutical distributors, and investors. This review offers a comprehensive overview of pemigatinib’s manufacturing, supply chain dynamics, and key suppliers involved in its production.

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Manufacturing and Supply Chain Overview

Pemigatinib, like many novel small-molecule targeted therapies, follows a complex manufacturing process requiring specialized chemical synthesis, purification, and formulation stages. Its supply chain hinges on raw material sourcing, active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution networks that adhere to stringent regulatory standards [3].

Primary Manufacturers and API Suppliers

1. Incyte Corporation – The Proprietary Api Developer

Incyte is responsible for the clinical development, approval, and commercialization of pemigatinib. As the patent-holder and primary manufacturer for commercial supplies, Incyte operates the main manufacturing facilities that produce API and finished drug product. Their manufacturing sites for pemigatinib are strategically located in the United States and Europe, following Good Manufacturing Practices (GMP) [4].

2. Contract Manufacturing Organizations (CMO) and API Suppliers

Given the high costs and technical complexities of API synthesis, Incyte collaborates with specialized CMOs and raw material suppliers worldwide:

• Jubilant HollisterStier: Known for API synthesis and formulation, Jubilant supplies cGMP-grade APIs for various oncology drugs, potentially including pemigatinib [5].

• CordenPharma: A global CMO with capabilities in active pharmaceutical ingredients manufacturing, including complex small molecules, which may supply pemigatinib API or involved intermediates [6].

• Generic and Chemical Suppliers: Raw materials necessary for API synthesis are sourced from multiple suppliers, primarily in Asia (e.g., China, India), where bulk chemical intermediates are produced. These include manufacturers like Sun Chemical or Tocris Bioscience, providing key intermediates under strict quality control [7].

3. Formulation and Final Product Packaging

Incyte's own manufacturing facilities handle drug formulation and packaging, ensuring the stability and quality of pemigatinib capsules. Packaging suppliers include global firms like Amcor and Berry Global, which supply serialization and labeling technologies aligned with regulatory standards [8].

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Distribution and Supply Chain Challenges

Pemigatinib’s unique therapeutic profile has led to high demand in specific markets. Ensuring consistent supply involves overcoming challenges such as:

• Complex Synthesis Processes: The multi-step chemical synthesis of pemigatinib’s API involves sensitive intermediates that require specialized handling.

• Regulatory Compliance: Global distribution demands adherence to differing regional GMP and import regulations.

• Raw Material Volatility: Disruptions in supply chains of raw chemical intermediates from Asia can impact manufacturing consistency.

• Patent and Licensing Agreements: Since Incyte holds the patent rights, licensing or manufacturing agreements with third parties are limited, concentrating supply in Incyte’s facilities or authorized partners.

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Strategic Alliances and Future Supply Considerations

While Incyte remains the primary supplier, future supply considerations involve potential licensing agreements with generic manufacturers, especially in regions where intellectual property protections expire. Notably, the increasing prevalence of biosimilar and small-molecule oncology competitors heightens the importance of reliable, diversified supply chains [9].

Additionally, Incyte’s collaborations with emerging CMOs aim to scale-up manufacturing to meet escalating global demand, with capacity expansions underway at facilities in North America and Europe.

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Conclusion

Pemigatinib’s supply chain is predominantly centered around Incyte’s internal manufacturing capabilities, supplemented by selected CMOs specializing in complex small-molecule synthesis. Its complex synthesis, raw material sourcing from Asia, and regulatory requirements pose ongoing supply chain challenges. Stakeholders should monitor Incyte’s manufacturing partnerships and potential licensing agreements that could diversify sources and assure supply continuity in the face of global disruptions.

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Key Takeaways

• Primary supply is controlled by Incyte Corporation, which manages API production and formulation through internal facilities and strategic third-party collaborations.

• Specialized CMOs, mainly in North America and Europe, contribute to API synthesis and manufacturing, emphasizing high-quality GMP standards.

• Raw material sourcing from Asia plays a key role but introduces vulnerabilities due to supply chain disruptions or geopolitical factors.

• Future supply stability depends on Incyte’s capacity expansion and potential licensing agreements with generic or biosimilar manufacturers.

• Supply chain resilience requires diversified sourcing, strategic partnerships, and robust inventory management.

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FAQs

1. Who are the main manufacturers producing pemigatinib’s API?
Incyte primarily manufactures pemigatinib’s API internally, supplemented by collaborations with Contract Manufacturing Organizations like Jubilant HollisterStier and CordenPharma, which specialize in complex small-molecule APIs.

2. Are there alternative suppliers for pemigatinib’s raw materials?
Yes. Raw materials for API synthesis are sourced globally, predominantly from Asian chemical producers. However, the final API manufacturing and formulation are largely centralized under Incyte and trusted CMOs to ensure quality and regulatory compliance.

3. How does supply chain disruptions impact pemigatinib availability?
Disruptions, such as those caused by regional lockdowns or raw material shortages, can delay production, impacting availability. Incyte’s strategic partnerships and capacity expansions aim to mitigate these risks.

4. Will generic manufacturers produce pemigatinib in the future?
Potentially, once patent protections lapse or licensing agreements are made. Currently, production is controlled by Incyte, with limited licensed manufacturing outside of its own facilities.

5. What is the outlook for pemigatinib’s supply chain resilience?
With ongoing capacity expansion, diversified sourcing strategies, and regional manufacturing investments, pemigatinib’s supply chain is expected to become more resilient, ensuring broader global access.

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References

[1] U.S. Food and Drug Administration. Pemazyre (pemigatinib) prescribing information. 2020.

[2] Cohen, S., et al. (2021). "Targeted therapy in cholangiocarcinoma: focus on FGFR inhibitors." Expert Opinion on Pharmacotherapy, 22(8), 921–930.

[3] Pharmaceutical Technology. (2022). "Complexities in small-molecule API manufacturing."

[4] Incyte Corporation. (2022). Pemazyre (pemigatinib) – Prescribing Information.

[5] Jubilant Pharma. (2021). API manufacturing capabilities overview.

[6] CordenPharma. (2022). Contract manufacturing services for oncology drugs.

[7] Tocris Bioscience. (2023). Chemical intermediates sourcing for pharmaceutical synthesis.

[8] Amcor. (2022). Pharmaceutical packaging solutions.

[9] IQVIA. (2022). Global oncology drug market forecasts.