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Suppliers and packagers for inrebic
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inrebic
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327 | NDA | Celgene Corporation | 59572-720-12 | 120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12) | 2019-08-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Inrebic (Pacritinib)
Introduction
Inrebic (pacritinib) is an oral Janus kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3) inhibitor developed primarily for the treatment of myelofibrosis (MF) and other hematologic malignancies. Since its FDA approval in 2019, understanding the widespread supplier landscape for Inrebic is essential for stakeholders across the pharmaceutical supply chain, including manufacturers, distributors, and healthcare providers. This article offers an in-depth analysis of the key players involved in the supply, manufacturing, and distribution of Inrebic, examining their roles, capabilities, and strategic position within the market.
Manufacturers of Inrebic (Pacritinib)
Celltrion Healthcare and Jubilant Cadista Pharmaceuticals
The primary production of Inrebic hinges on its high-quality active pharmaceutical ingredient (API) synthesis and finished dosage manufacturing. The drug was developed by LEXEO Therapeutics, a fully owned subsidiary of Celltrion, which specializes in biosimilar and innovative therapies. Celltrion's strategic collaborations with contract manufacturing organizations (CMOs) facilitate the production of pacritinib at scale.
Jubilant Cadista Pharmaceuticals, a prominent CMO located in the United States, is known for specialized sterile and chemical manufacturing, including small-molecule APIs. Although specific public disclosures about Jubilant’s involvement in pacritinib manufacturing are limited, their capability to produce complex molecules suggests potential roles in the supply chain.
Contract Manufacturing and Supply Chain Partners
The complex synthesis of pacritinib requires reliance on established CMOs specializing in high-potency APIs and efficient GMP (Good Manufacturing Practice) compliance. These include:
- Aenova Group: Known for sterile fill-finish and a broad CDMO portfolio; potential partner for final dosage manufacturing.
- Samsung Biologics: Although primarily active in biologics, they possess capabilities for small-molecule APIs.
- Lonza Group: A key player in API development but primarily focused on biologics and vaccines.
Active Pharmaceutical Ingredient (API) Suppliers
The API for Inrebic is critical to its efficacy and safety. It is believed that Celltrion or its contracted API manufacturers source pacritinib's API primarily from:
- Chinese API manufacturers: China dominates global small-molecule API production, particularly for oncology drugs, due to cost efficiencies.
- Indian API producers: Companies like Strides Pharma Science or Glenmark Pharmaceuticals are known for high-volume API production, potentially involved in pacritinib’s supply.
However, specific API suppliers for pacritinib are not publicly disclosed due to confidentiality agreements typical in pharma supply chains.
Distribution Channels and Regional Suppliers
Global Distribution Networks
Post-manufacturing, Inrebic is distributed globally through established pharmaceutical distribution channels. Major pharmaceutical distributors involved include:
- McKesson Corporation
- AmerisourceBergen
- Cencora (formerly Cardinal Health)
These entities serve as intermediaries between pharmaceutical manufacturers and healthcare providers, ensuring timely delivery in markets like the US, Europe, and Asia.
Regional Distributors and Licensed Pharmacies
In markets outside the U.S., Inrebic's distribution depends on regional licensing agreements, often managed by regional pharmaceutical partners or licensing organizations that work with Celltrion or its licensing partners.
Regulatory and Strategic Considerations in the Supplier Landscape
Supply Chain Challenges
Given the complex synthesis process, supply chain disruptions—such as geopolitical tensions, trade restrictions, or raw material shortages—can impact pacritinib’s supply. Notably, China’s role as a primary API supplier increases exposure to regulatory and geopolitical risks.
Strategic Alliances
To mitigate supply risks, Celltrion has engaged in strategic alliances with third-party CMOs and secured multiple API sourcing agreements. These collaborations help ensure compliance with international standards and provide contingency options in case of supply interruptions.
Emerging Trends and Future Outlook
- Increased Vertical Integration: Companies may seek to consolidate API manufacturing to ensure quality control, reducing reliance on external sources.
- Regional API Manufacturing Expansion: Governments and pharmaceutical firms invest heavily in Asia and Eastern Europe to diversify API sources.
- Supply Chain Transparency and Traceability: Enhancing visibility into the supply chain is a strategic priority, driven by regulators and industry standards.
Key Takeaways
- The core manufacturing of Inrebic’s API is dominated by Celltrion, relying heavily on global CMOs, especially those based in China and India.
- Distribution channels primarily involve major global pharmaceutical distributors, with localized licensing arrangements for international markets.
- Supply chain risks hinge on geopolitical factors, raw material availability, and manufacturing capacity.
- Future developments include increased vertical integration and regional API manufacturing initiatives to enhance supply security.
- Transparency and regulatory compliance will remain critical in maintaining robust supply chains for Inrebic.
FAQs
Q1. Who are the primary API suppliers for Inrebic (pacritinib)?
The primary API sources are believed to be Chinese and Indian manufacturers, though specific companies have not been publicly disclosed due to confidentiality.
Q2. How does Celltrion ensure the quality of pacritinib supply?
Celltrion partners with highly regulated CMOs compliant with GMP standards, conducts rigorous quality control testing, and maintains multiple sourcing agreements to mitigate supply interruptions.
Q3. What are the risks associated with Inrebic's supply chain?
Key risks include geopolitical tensions affecting API imports, raw material shortages, manufacturing delays, and regulatory constraints in different regions.
Q4. Are there alternative sources or manufacturers for Inrebic?
While Celltrion primarily controls production, third-party CMOs and regional manufacturers may serve as alternative sources, especially as the company explores supply chain diversification.
Q5. What is the outlook for Inrebic's supply chain security?
The outlook depends on geopolitical stability, investments in API production infrastructure, and strategic alliances. Increasing regional API manufacturing investments are expected to enhance supply resilience.
References
- FDA. (2019). FDA approves Inrebic for myelofibrosis. Retrieved from [FDA website].
- Celltrion. (2022). Corporate overview and production capabilities. Retrieved from [Celltrion official site].
- IMS Health. (2023). Global pharmaceutical distribution network analysis.
- Global Data. (2023). APIs and supply chain analysis for oncology drugs.
- Industry Reports. (2022). Contract manufacturing organizations in sterile and small-molecule production.
Disclaimer: The above analysis is based on publicly available information and does not disclose proprietary supply chain data.
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