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

Pemigatinib Drug Supply Chain Analysis

Last updated: February 19, 2026

Pemigatinib, a selective fibroblast growth factor receptor 1 (FGFR1) inhibitor, is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement. This analysis identifies key suppliers involved in the pemigatinib drug supply chain, focusing on active pharmaceutical ingredient (API) manufacturing, finished dosage form (FDF) production, and critical raw materials.

What Are the Key Suppliers for Pemigatinib API Manufacturing?

The manufacturing of pemigatinib's active pharmaceutical ingredient (API) is a multi-step chemical synthesis process requiring specialized expertise and adherence to stringent Good Manufacturing Practices (GMP). While specific contract manufacturing organizations (CMOs) directly contracted by the originator, Incyte Corporation, are proprietary, industry analysis points to several potential or established suppliers of complex heterocyclic compounds and intermediates critical to pemigatinib synthesis. These include companies with demonstrated capabilities in multi-step organic synthesis, chiral chemistry, and handling potent compounds.

• Lonza Group: A global leader in pharmaceutical contract manufacturing, Lonza has extensive experience in API development and commercial manufacturing for oncology drugs. Their capabilities in complex synthesis and large-scale production make them a strong candidate for supplying pemigatinib API or key intermediates.
• Catalent Pharma Solutions: Catalent offers integrated drug development and manufacturing solutions, including API synthesis. Their expertise in handling highly potent APIs (HPAPIs) and custom synthesis aligns with the requirements for pemigatinib production.
• WuXi AppTec: This China-based company provides a broad range of R&D and manufacturing services for the pharmaceutical and biotech industries. WuXi AppTec's extensive network of facilities and deep expertise in complex chemical synthesis positions them as a potential supplier for intermediates or the final API.
• Evonik Industries: Evonik, through its Health Care business line, offers custom manufacturing services for APIs and intermediates. Their focus on advanced synthesis technologies and regulatory compliance would be beneficial for pemigatinib production.

These companies typically operate under strict confidentiality agreements with drug developers. Direct confirmation of their involvement in the pemigatinib API supply chain is not publicly disclosed. However, their established track records in oncology API manufacturing and their service offerings are indicative of their potential role.

Who Manufactures Pemigatinib Finished Dosage Forms (FDF)?

The finished dosage form (FDF) of pemigatinib is supplied as oral capsules. The formulation and packaging of the FDF also rely on specialized CMOs capable of handling the specific requirements for oral solid dosage forms, including encapsulation, quality control, and packaging for commercial distribution.

• AbbVie (formerly Allergan Biologics): While Incyte is the originator, large pharmaceutical companies with substantial manufacturing networks, including those acquired or previously operated under different entities, often provide FDF manufacturing services. AbbVie has broad capabilities in FDF manufacturing.
• PCI Pharma Services: A leading provider of integrated pharmaceutical outsourcing solutions, PCI offers sterile and non-sterile drug product manufacturing, including complex solid dosage forms and packaging services. Their global network of facilities supports commercial supply.
• Recipharm AB: This Swedish company is a contract development and manufacturing organization (CDMO) that provides manufacturing services for pharmaceuticals, including solid dosage forms. They operate multiple facilities across Europe.
• Baxter International: Known for its contract manufacturing services, Baxter offers capabilities in sterile and non-sterile drug product manufacturing, which could encompass FDF production for oral medications like pemigatinib.

The specific CMOs contracted for pemigatinib FDF manufacturing are also typically confidential. The selection of an FDF manufacturer depends on factors such as capacity, regulatory compliance, geographic location for supply chain optimization, and cost.

What Are the Critical Raw Materials and Their Suppliers?

The synthesis of pemigatinib involves a complex series of chemical reactions utilizing various raw materials and reagents. Identifying precise suppliers for each specific intermediate is challenging due to the proprietary nature of pharmaceutical supply chains. However, the chemical structure of pemigatinib suggests the need for:

• Substituted Pyrazole Derivatives: The core structure of pemigatinib includes a pyrazole ring functionalized with specific substituents. Suppliers of advanced heterocyclic building blocks are crucial.
  • Sigma-Aldrich (Merck KGaA): A broad catalog supplier of fine chemicals and reagents, Sigma-Aldrich provides a wide array of pyrazole derivatives and other organic intermediates used in pharmaceutical research and development.
  • TCI (Tokyo Chemical Industry Co., Ltd.): TCI is another major supplier of specialty organic chemicals, offering a comprehensive selection of heterocyclic compounds and building blocks suitable for complex API synthesis.
• Aryl Halides and Amines: These are common coupling partners and functionalization agents in organic synthesis.
  • Thermo Fisher Scientific: Offers a vast portfolio of chemicals, including various aryl halides and amines, essential for pharmaceutical synthesis.
  • Acros Organics (Thermo Fisher Scientific): A brand under Thermo Fisher Scientific, Acros Organics provides a range of organic reagents and building blocks.
• Boronic Acids and Esters: Used in cross-coupling reactions (e.g., Suzuki coupling), which are frequently employed in the synthesis of complex organic molecules.
  • Combi-Blocks: Specializes in the synthesis and supply of advanced intermediates and building blocks for drug discovery and development, including boronic acids and esters.
  • Apollo Scientific: Offers a wide range of building blocks and reagents for organic synthesis, including boronic acids.
• Solvents: High-purity solvents are critical for various reaction steps and purification processes.
  • Avantor (VWR): A global supplier of laboratory products and services, Avantor provides a comprehensive range of high-purity solvents essential for pharmaceutical manufacturing.
  • J.T. Baker (Avantor): A well-known brand for laboratory chemicals, J.T. Baker offers a range of high-purity solvents meeting pharmaceutical specifications.

The supply of these critical raw materials requires robust quality control measures to ensure purity, consistency, and compliance with regulatory standards. Drug manufacturers typically qualify multiple suppliers for key raw materials to mitigate supply chain risks.

What Are the Regulatory Considerations for Pemigatinib Suppliers?

Suppliers involved in the pemigatinib supply chain must adhere to a stringent regulatory framework to ensure the safety, efficacy, and quality of the final drug product. Key regulatory considerations include:

• Good Manufacturing Practices (GMP): All API and FDF manufacturers must comply with cGMP regulations as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities. This includes robust quality management systems, detailed batch records, process validation, and change control procedures.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control of the API. Innovator companies then reference these DMFs in their drug applications.
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide harmonized standards for pharmaceutical development and manufacturing. Relevant ICH guidelines include Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and Q10 (Pharmaceutical Quality System).
• Supply Chain Security and Traceability: Regulations increasingly emphasize supply chain integrity and the prevention of counterfeit drugs. Suppliers must implement measures for product authentication, secure packaging, and robust traceability systems.
• Environmental, Health, and Safety (EHS) Regulations: Pharmaceutical manufacturing involves the use of hazardous chemicals. Suppliers must comply with all applicable EHS regulations regarding chemical handling, waste disposal, and worker safety.

Regulatory compliance is a continuous process, requiring regular audits by regulatory agencies and the drug innovator. Any deviation from these standards can lead to significant supply chain disruptions and regulatory action.

What Are the Risks and Mitigation Strategies in the Pemigatinib Supply Chain?

The pemigatinib supply chain, like any pharmaceutical supply chain, faces inherent risks. These risks can impact drug availability, cost, and quality.

• Single Sourcing of Critical Intermediates or APIs: Reliance on a single supplier for a key component can lead to significant disruptions if that supplier experiences production issues, regulatory problems, or geopolitical instability.
  • Mitigation: Dual sourcing for critical raw materials and intermediates, developing alternative synthesis routes where feasible, and maintaining strategic inventory levels.
• Quality Control Failures: Substandard raw materials or manufacturing process deviations can lead to batch rejections, product recalls, and regulatory scrutiny, impacting patient access.
  • Mitigation: Rigorous supplier qualification programs, comprehensive incoming material testing, ongoing supplier audits, and robust in-process and final product quality control.
• Geopolitical and Economic Instability: Global supply chains are vulnerable to trade disputes, natural disasters, pandemics, and economic downturns, which can affect the availability and cost of raw materials and finished products.
  • Mitigation: Diversifying supplier locations geographically, building strong relationships with suppliers, and conducting supply chain risk assessments.
• Intellectual Property (IP) Infringement: While pemigatinib is protected by patents, challenges to patent validity or unauthorized manufacturing of generics can create uncertainty.
  • Mitigation: Strong IP protection strategy, diligent monitoring of the competitive landscape, and proactive legal defense.
• Capacity Constraints: As demand for pemigatinib grows, existing manufacturing capacity may become a bottleneck.
  • Mitigation: Long-term capacity planning with CMOs, investing in scaling up production, and exploring new manufacturing technologies.

Effective supply chain management requires a proactive approach to risk identification, assessment, and the implementation of robust mitigation strategies.

Key Takeaways

• The pemigatinib supply chain involves specialized API and FDF manufacturers, with Lonza, Catalent, WuXi AppTec, and Evonik potential API suppliers, and AbbVie, PCI Pharma Services, Recipharm, and Baxter as potential FDF manufacturers.
• Critical raw materials include substituted pyrazoles, aryl halides, amines, boronic acids, and high-purity solvents, with suppliers like Sigma-Aldrich, TCI, Thermo Fisher Scientific, Avantor, Combi-Blocks, and Apollo Scientific being key players.
• Suppliers must adhere to stringent GMP, ICH guidelines, and other regulatory requirements.
• Key risks include single sourcing, quality control failures, geopolitical instability, IP challenges, and capacity constraints, necessitating robust mitigation strategies such as dual sourcing, rigorous quality control, and geographic diversification.

Frequently Asked Questions

1. Are there any publicly listed CMOs that explicitly state they manufacture pemigatinib API?

No, specific contract manufacturing organizations (CMOs) that explicitly state they manufacture pemigatinib API for Incyte Corporation are not publicly disclosed due to confidentiality agreements.

2. What is the typical lead time for securing a new supplier for a critical intermediate in a complex API synthesis like pemigatinib?

The lead time for securing a new supplier for a critical intermediate can range from six months to over two years, encompassing supplier qualification, process validation, and regulatory filing if necessary.

3. How does Incyte Corporation ensure the quality of raw materials sourced from global suppliers?

Incyte likely employs a multi-faceted approach including stringent supplier qualification processes, on-site audits, robust analytical testing of incoming materials, and adherence to supplier quality agreements.

4. What are the primary regulatory hurdles for a new CMO seeking to supply intermediates for pemigatinib manufacturing?

Primary regulatory hurdles include demonstrating compliance with current Good Manufacturing Practices (cGMP), having a robust Quality Management System, and potentially supporting the submission of Drug Master Files (DMFs) to relevant health authorities.

5. Can secondary suppliers (second-tier suppliers) of raw materials for pemigatinib synthesis be identified?

Identifying secondary suppliers is exceptionally difficult as these relationships are typically private and embedded within the primary supplier's own supply chain management, often without direct disclosure to the drug innovator.

Citations

[1] Incyte Corporation. (n.d.). Pemigatinib. Retrieved from https://www.incyte.com/pemigatinib (Note: While this is a general company page, it confirms Incyte as the originator of pemigatinib.) [2] U.S. Food & Drug Administration. (n.d.). Good Manufacturing Practice (GMP). Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/good-manufacturing-practice-gmp [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/guidelines [4] Lonza Group AG. (n.d.). Small Molecules. Retrieved from https://www.lonza.com/services/small-molecules [5] Catalent, Inc. (n.d.). Small Molecule API Development & Manufacturing. Retrieved from https://www.catalent.com/capabilities/api-development-manufacturing/small-molecule-api/ [6] WuXi AppTec. (n.d.). Small Molecule Process R&D and Manufacturing. Retrieved from https://www.wuxiapptec.com/services/small-molecule-process-rd-manufacturing [7] Evonik Industries AG. (n.d.). Custom Manufacturing Organization. Retrieved from https://corporate.evonik.com/en/business/nutrition-care/health-care/custom-manufacturing-organization/Pages/default.aspx [8] PCI Pharma Services. (n.d.). Drug Product Services. Retrieved from https://www.pciservices.com/services/drug-product-services [9] Merck KGaA. (n.d.). Sigma-Aldrich. Retrieved from https://www.sigmaaldrich.com/ [10] Tokyo Chemical Industry Co., Ltd. (n.d.). Company Overview. Retrieved from https://www.tcichemicals.com/en/ [11] Thermo Fisher Scientific Inc. (n.d.). Chemicals. Retrieved from https://www.thermofisher.com/us/en/home/chemical-sciences.html [12] Avantor, Inc. (n.d.). Laboratory Products and Services. Retrieved from https://www.avantorinc.com/