pemazyre: Pharmaceutical manufacturers, suppliers, and packagers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Pemazyre (pemigatinib) is an orally administered medication developed by Reliance Therapeutics, primarily used to treat specific types of cancer, notably cholangiocarcinoma with fibroblast growth factor receptor (FGFR) alterations. As a targeted therapy, Pemazyre’s supply chain is vital for ensuring consistent patient access, especially given its status as a specialized oncology medication. This article provides an in-depth analysis of Pemazyre's suppliers, including manufacturing sources, supply chain considerations, and key players involved in delivering this drug worldwide.

Manufacturing and Key Suppliers of Pemazyre

1. Dependence on Reliance Therapeutics’ Manufacturing Facilities

Reliance Therapeutics, the innovator behind Pemazyre, initially developed the drug with a focus on ensuring high-quality synthesis of active pharmaceutical ingredients (APIs) and finished formulations. The company's manufacturing processes are critical to supply stability, given the complexities involved in producing FGFR inhibitors.

API Production: The core component of Pemazyre, the PEM-based API (pemigatinib), is synthesized through complex chemical processes that require specialized manufacturing facilities equipped for high potency compounds. Reliance Therapeutics maintains or partners with Contract Manufacturing Organizations (CMOs) that conform to Good Manufacturing Practices (GMP), ensuring quality and compliance.
Formulation and Packaging: Final drug formulations undergo strict quality controls before distribution. The manufacturing of finished dosage forms often occurs in facilities approved by regulatory agencies such as the FDA or EMA.

2. Contract Manufacturing Organizations

Given the specialized nature of API and drug product manufacturing, Reliance Therapeutics appears to rely heavily on strategic partnerships with CMOs. These organizations serve as critical suppliers that provide:

Raw Material Procurement: Suppliers of starting materials and chemical intermediates essential for API synthesis.
API Synthesis: Contract manufacturers specializing in complex chemical production, capable of scaling as demand for Pemazyre increases.
Finished Dose Manufacturing: Companies with expertise in capsule and tablet formulation for reliable distribution.

Leading global CMOs in the pharmaceutical industry, such as Lonza, Cambrex, and WuXi AppTec, are well-known for producing APIs and finished drug products under strict regulatory standards and could be involved in Pemazyre's supply chain. However, specific contractual details remain proprietary.

Global Distribution and Supply Chain Dynamics

3. Geographic Distribution and Regulatory Approvals

Pemazyre received FDA approval in 2020 and subsequently gained approval in regions including the European Union, Japan, and other territories. This expansion necessitates a geographically dispersed supply chain:

North America: Reliance’s primary manufacturing centers or contracted CMOs in the US facilitate high-volume distribution.
Europe and Asia: Agreements with local or regional CMOs enhance supply security to meet regional regulatory requirements.

4. Supply Chain Challenges

The complex synthesis of Pemazyre's API, coupled with its status as an oncology drug, underscores supply chain risks:

Raw Material Scarcity: High-value or specialized chemicals can be susceptible to shortages.
Manufacturing Bottlenecks: Limited number of facilities capable of producing high-potency APIs.
Regulatory Compliance: Ensuring all manufacturing sites meet varying regional GMP standards.

Recent disruptions, such as those caused by COVID-19, highlighted vulnerabilities in global pharmaceutical supply chains, emphasizing the importance of diversified sourcing and strategic stockpiling for drugs like Pemazyre.

Major Players and Strategic Relationships

5. Contract Manufacturing and Supply Partners

While specific details on Pemazyre’s supply chain partners are confidential, industry knowledge suggests reliance on the following types of organizations:

CDMOs specialized in high-potency APIs: These include Lonza, WuXi AppTec, or WuXi STA, known for their capabilities in complex chemical synthesis and large-scale production.
Regional Manufacturers: Localized partnerships in regions like Europe and Asia to streamline distribution and meet regional regulatory requirements.

Reliance Therapeutics likely maintains strategic relationships with these manufacturers to mitigate supply risks, comply with Good Distribution Practices (GDP), and ensure uninterrupted supply.

6. Strategic Stockpiling and Supply Agreements

To manage global demand, Reliance Therapeutics has likely entered into long-term supply agreements with manufacturers, ensuring priority access to raw materials and manufacturing capacity. Stockpiling critical batches can cushion against unforeseen disruptions.

Regulatory and Supply Chain Compliance

The security of Pemazyre supply also hinges on adherence to stringent regulatory standards. Key supplier facilities must comply with internationally accepted GMP guidelines, and ongoing inspections by agencies such as the FDA ensure consistent quality. As part of compliance, suppliers are also responsible for validation processes, stability testing, and quality assurance protocols.

Future Outlook on Pemazyre’s Suppliers

The increasing demand for Pemazyre, driven by expanded indications and regional approvals, is likely to incentivize Reliance Therapeutics to diversify its supplier base further. Strategies may include:

Expanding manufacturing capacity with existing CMOs.
Identifying additional contractors capable of producing GMP-grade APIs at scale.
Investing in regional supply chains to mitigate geopolitical risks.

As the oncology market evolves, securing multiple sourcing options will be critical to maintaining a reliable supply pipeline for Pemazyre.

Key Takeaways

Dependence on specialized CMOs: Pemazyre's production largely relies on contract manufacturing organizations with expertise in high-potency APIs and complex formulations.
Global distribution complexity: Regional regulatory approvals necessitate a geographically diverse supply chain to ensure timely delivery.
Supply chain resilience: Limited number of high-capacity manufacturers and raw material variability pose risks that Reliance Therapeutics must manage through strategic partnerships and stockpiling.
Regulatory compliance critical: Maintaining GMP standards across all manufacturing sites is essential to uphold product quality and supply continuity.
Market growth implications: Growing demand will likely prompt diversification of suppliers and increased manufacturing capacity investments.

FAQs

1. Who are the primary contract manufacturers involved in Pemazyre production?
While specific contractual details are confidential, global players like WuXi AppTec, Lonza, and WuXi STA are probable partners, given their expertise in high-potency API synthesis and sterile manufacturing.

2. How does supply chain disruption impact Pemazyre availability?
Disruptions in raw material supply, manufacturing capacity constraints, or regulatory delays can lead to shortages, impacting patient access to this critical oncology medication.

3. Are regional manufacturing facilities used for Pemazyre?
Yes. To comply with regional regulations and reduce supply chain risks, Reliance Therapeutics likely partners with regional CMOs for distribution in regions such as Europe and Asia.

4. What measures are taken to ensure Pemazyre supply chain security?
Reliance Therapeutics probably employs diversified sourcing, long-term supply agreements, regional manufacturing strategies, and inventory management to mitigate risks.

5. Will the supply chain for Pemazyre expand in the future?
Yes. As demand increases due to broader approvals, supply chain expansion through additional manufacturing partners and capacity investments is expected to maintain consistent supply.

References

[1] U.S. Food and Drug Administration (FDA). Pemazyre (pemigatinib) approval information. 2020.
[2] European Medicines Agency (EMA). Summary of Product Characteristics: Pemazyre. 2021.
[3] Reliance Therapeutics Annual Report 2022.
[4] Contract Manufacturing Organization Capabilities, Lonza, WuXi AppTec, 2023.
[5] Global Pharmaceutical Supply Chain Resilience Report, WHO, 2022.

Suppliers and packagers for pemazyre

pemazyre

Suppliers for the pharmaceutical drug: Pemazyre