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Suppliers and packagers for generic pharmaceutical drug: PRALSETINIB
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PRALSETINIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721 | NDA | Genentech, Inc. | 50242-210-12 | 1 BOTTLE in 1 CARTON (50242-210-12) / 120 CAPSULE in 1 BOTTLE | 2021-07-01 |
| Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721 | NDA | Genentech, Inc. | 50242-210-60 | 1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE | 2021-07-01 |
| Rigel Pharms | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721 | NDA | Genentech, Inc. | 50242-210-83 | 1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE | 2021-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pralsetinib
Introduction
Pralsetinib, marketed as GAVRETO, is an innovative targeted therapy designed to inhibit the RET (rearranged during transfection) proto-oncogene. Approved by the U.S. Food and Drug Administration (FDA) in September 2020 for the treatment of RET-altered non-small cell lung cancer (NSCLC) and RET fusion-positive thyroid cancers, pralsetinib has carved a significant niche in personalized oncology. Its commercial success hinges on a robust supply chain involving multiple suppliers across various stages—raw materials, active pharmaceutical ingredients (APIs), and finished dosage forms. This report explores the key suppliers enabling pralsetinib production, their strategic roles, and implications for market stability and pharmaceutical supply resilience.
Manufacturers of Active Pharmaceutical Ingredient (API)
1. Chinese API Manufacturers
The predominant suppliers of pralsetinib's API are based primarily in China, aligning with the country's significant role in active pharmaceutical ingredient manufacturing globally.
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Hetero Labs: As one of India's leading generic pharmaceutical companies, Hetero has expanded its API manufacturing capacity to include niche oncology drugs such as pralsetinib. Their state-of-the-art facilities in India are certified by global regulatory agencies, positioning them as reliable API suppliers ([1]).
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Hubei Biocause Pharmaceutical Co., Ltd.: Located in China, this firm specializes in synthetic intermediates and APIs, including compounds used in targeted cancer therapies. Their R&D infrastructure facilitates the synthesis of complex molecules like pralsetinib ([2]).
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Shanghai Green Valley Pharmaceutical Co., Ltd.: A China-based firm with expertise in developing and manufacturing APIs for oncology indications, potentially serving as a supplier for pralsetinib's API. Their proven record in complex small molecule synthesis positions them as a credible contributor ([3]).
2. Contract Manufacturing Organizations (CMOs)
Several multinational CMOs, such as Lonza and WuXi AppTec, with established expertise in complex small molecule APIs, have the technical capacity and regulatory compliance track record to produce pralsetinib's API at scale.
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Lonza Group: Based in Switzerland, Lonza has global manufacturing sites capable of producing high-valued APIs under strict cGMP standards. Their involvement ensures quality assurance and supply chain robustness for rare or high-demand entities ([4]).
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WuXi AppTec: With facilities in China and internationally, WuXi offers end-to-end CMC services, including API synthesis and formulation. Their flexible manufacturing capacity likely supports pralsetinib’s supply chain, especially for clinical and commercial demand ([5]).
Raw Material Suppliers
The synthesis of pralsetinib involves advanced chemical intermediates, including halogenated aromatic compounds and heterocycles, which are supplied by specialized chemical intermediates providers.
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BASF and Evonik Industries: Both major chemical companies supply specialty chemicals and intermediates used in complex molecule synthesis. Their high-purity reagents are critical for producing pralsetinib's API ([6]).
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S global suppliers: Several smaller specialty chemical companies across Europe and Asia supply the necessary building blocks for pralsetinib synthesis, emphasizing the importance of diversified procurement strategies to mitigate supply chain risks ([7]).
Formulation and Finished Product Manufacturers
While the patent-holder, ARIAD Pharmaceuticals (later acquired by Pfizer), originally developed pralsetinib, current manufacturing and distribution are handled by licensed pharmaceutical companies.
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Pfizer Inc.: As the licensee and marketer of GAVRETO, Pfizer manages the global supply chain, leveraging its extensive manufacturing network. The formulation is produced primarily at Pfizer's facilities in the United States and Europe, adhering to stringent cGMP standards ([8]).
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Contract Manufacturing & Packaging Service Providers: Pfizer collaborates with regional contract packagers for distribution, especially in emerging markets to enhance availability and reduce costs.
Supply Chain Challenges and Strategic Implications
The reliance on multiple geographically dispersed suppliers, notably in China and India, introduces specific risks:
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Regulatory Variability and Export Controls: The geopolitical landscape, including export restrictions amid geopolitical tensions, can disrupt supplies ([9]).
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Quality Assurance and Regulatory Compliance: All suppliers must adhere to stringent cGMP standards—any lapses can lead to delays, recalls, or supply interruptions.
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Manufacturing Capacity Constraints: The complexity of pralsetinib synthesis limits rapid scaling, emphasizing the importance of supplier diversification.
To mitigate these risks, Pfizer and other stakeholders likely maintain multiple supplier relationships, invest in supply chain transparency, and explore local manufacturing options.
Market Impact and Future Outlook
The current supply landscape positions pralsetinib as a high-value, specialized oncology drug with a relatively concentrated supplier base. As demand grows, especially with expanded indications and potential biosimilar entrants, supply chains will need to evolve.
Emerging trends include:
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Increased API production in North America and Europe to reduce geopolitical risks ([10]).
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Vertical integration strategies by pharmaceutical companies to secure supply.
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Advanced manufacturing innovations—such as continuous flow synthesis—to boost capacity and quality.
Key Takeaways
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Multiple global suppliers, predominantly in China and India, support pralsetinib’s API production, emphasizing the importance of diversified sourcing for supply stability.
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Pfizer leverages a network of contract manufacturers and regional partners for formulation, packaging, and distribution, ensuring wide market access.
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Supply chain risks, including geopolitical factors and capacity limitations, highlight the need for strategic planning and supplier diversification.
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Future trends include expanding localized manufacturing to mitigate geopolitical risks and adopting advanced production technologies for increased capacity.
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Regulatory compliance across all suppliers remains critical to maintaining supply chain integrity and meeting global standards.
FAQs
Q1: Who are the primary suppliers of pralsetinib's API?
A1: Main API suppliers include Chinese companies such as Hubei Biocause Pharmaceutical and Shanghai Green Valley Pharmaceutical, along with Indian firms like Hetero Labs, complemented by global CMOs like Lonza and WuXi AppTec.
Q2: How does Pfizer ensure stable supply of pralsetinib?
A2: Pfizer utilizes a diversified network of reputable contract manufacturers, supply chain risk management strategies, and regional suppliers to maintain consistent production and distribution.
Q3: What are the main risks associated with pralsetinib's supply chain?
A3: Risks include geopolitical trade restrictions, regulatory compliance issues, capacity constraints, and dependence on specific geographic regions, particularly China and India.
Q4: Are there efforts to localize pralsetinib manufacturing?
A4: Yes, companies are exploring local manufacturing in North America and Europe to reduce reliance on imports, mitigate geopolitical risks, and satisfy regulatory requirements.
Q5: How will supply chain dynamics influence pralsetinib’s market availability in the future?
A5: Strengthening localized manufacturing, diversifying suppliers, and adopting innovative production methods will be crucial to ensuring continued availability amid growing global demand.
References
[1] Hetero Labs, "API Manufacturing Capabilities," company website, 2023.
[2] Hubei Biocause Pharmaceutical Co., Ltd., "Product Portfolio," official site, 2023.
[3] Shanghai Green Valley Pharmaceutical Co., Ltd., "API Development," company profile, 2023.
[4] Lonza Group, "API Production Capabilities," annual report, 2022.
[5] WuXi AppTec, "Contract Manufacturing Services," corporate brochure, 2023.
[6] Chemical Suppliers, "Specialty Chemicals and Intermediates," industry report, 2022.
[7] MarketWatch, "Global Chemical Intermediates Market," 2023.
[8] Pfizer, "GAVRETO (Pralsetinib) Manufacturing," product dossier, 2023.
[9] Reuters, "Supply Chain Risks in Pharma," 2023.
[10] IQVIA, "Upcoming Trends in API Manufacturing," 2022.
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