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Suppliers and packagers for MYTESI
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MYTESI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292 | NDA | Napo Pharmaceuticals, Inc. | 70564-802-60 | 60 TABLET, COATED in 1 BOTTLE (70564-802-60) | 2016-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MYTESI
Introduction
Mytesi (crofelemer) is an oral therapeutic developed primarily to treat diarrhea in HIV/AIDS patients. Approved by the U.S. Food and Drug Administration (FDA) in 2012, Mytesi addresses a significant unmet medical need by providing symptomatic relief without systemic absorption. As a plant-derived, non-opioid antidiarrheal agent, crofelemer's sourcing, manufacturing, and supply chain dynamics are critical for ensuring consistent availability and regulatory compliance. This comprehensive review explores the key suppliers involved in the production of crofelemer for Mytesi, examining the supply chain landscape, manufacturing partners, and market considerations.
Manufacturing and Supply Chain Overview of Crofelemer
Origin and Raw Material
Crofelemer is a unique, complex molecule sourced from the bark of the Croton lechleri tree, native to South America, particularly in Peru and Ecuador. The extraction process involves harvesting the sap, which is rich in proanthocyanidins and lignans, subsequently purified through proprietary processes to yield crofelemer.
Primary Suppliers of Raw Material: Sap and Plant Extracts
The supply chain begins with botanical raw materials, which are inherently influenced by geographic, environmental, and sustainable harvesting practices:
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Wild Harvesting and Cultivation: The initial raw material, Croton lechleri sap, is predominantly obtained through wild harvesting from native forests. Increasing demand has prompted pharmaceutical companies to collaborate with local harvesters while emphasizing sustainable and ethical sourcing practices.
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Suppliers of Plant Material and Sap: Several regional suppliers and cooperatives in Peru and Ecuador supply Croton lechleri sap. These entities often operate under fair trade and sustainability certifications, ensuring quality and compliance with international standards.
Note: Specific supplier names in this segment are typically kept proprietary due to confidentiality agreements. However, some known entities involved in sustainable botanical sourcing in South America include local cooperatives and export companies.
Extraction and Purification Suppliers
Once raw sap is obtained, it undergoes a series of purification steps:
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Extraction Partners: Contract manufacturing organizations (CMOs) specializing in botanical extracts often partner with raw material suppliers for initial processing. These entities extract and concentrate bioactive compounds, ensuring batch-to-batch consistency.
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Purification Facilities: Leading CMOs with expertise in botanical pharmaceuticals utilize proprietary purification technologies, such as chromatography and solvent extraction, to isolate crofelemer. These facilities are often located in North America or Europe for regulatory and quality oversight.
Manufacturers of Crofelemer
Original Manufacturer: Napo Pharmaceuticals
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Napo Pharmaceuticals was the pioneering company responsible for developing crofelemer from Croton lechleri sap, utilizing a proprietary extraction and purification process. Napo secured FDA approval for Mytesi and managed the supply chain during the initial commercialization phase.
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In 2017, Eli Lilly and Company acquired Napo Pharmaceuticals, integrating crofelemer into its broader portfolio.
Eli Lilly’s Role: Post-acquisition, Lilly assumed responsibility for manufacturing crofelemer at scale, leveraging a network of CMOs and suppliers for quality and regulatory compliance.
Current Manufacturing Partners
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Third-Party Contract Manufacturers: Eli Lilly collaborates with contract manufacturing organizations worldwide to produce crofelemer capsules. These CMOs are equipped with Good Manufacturing Practice (GMP) standards to ensure product quality and safety.
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Key Manufacturing Countries: The production facilities are primarily located in North America and Europe, with some partners in Asia, depending on capacity and expertise.
Note: Specific contract manufacturer names are confidential due to commercial agreements. However, the industry trend emphasizes partnerships with CMOs possessing strong experience in botanical pharmaceuticals and complex small molecules.
Distribution and Supply Network
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Global Distribution: Eli Lilly’s global distribution channel ensures Mytesi availability across North America and select international markets. The supply chain is tightly controlled, with regional warehouses and logistics partners adhering to pharmaceutical standards.
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Regulatory Considerations: Suppliers and manufacturers must comply with global Good Manufacturing Practice (GMP), Good Agricultural and Collection Practices (GACP) for botanical raw materials, and other regional guidelines to prevent contamination, ensure traceability, and uphold product integrity.
Market Dynamics and Supply Chain Challenges
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Sustainability and Ethical Sourcing: Growing emphasis on sustainability poses challenges in sourcing Croton lechleri sap. Ensuring eco-friendly harvesting and fair trade practices is vital to long-term supply stability.
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Supply Chain Disruptions: Factors such as geopolitical issues, environmental impacts, and pandemic-related disruptions can affect raw material availability and manufacturing capacity.
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Regulatory Compliance: Stringent quality controls across the supply chain are mandatory for maintaining FDA approval and international certifications, adding complexity to supplier qualification and audits.
Emerging Trends and Future Outlook
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Synthetic Alternatives: To mitigate raw material scarcity, research into synthetic or biotechnological production of crofelemer may evolve, though current reliance remains on botanical sourcing.
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Diversification of Suppliers: Eli Lilly and other stakeholders are increasingly diversifying their supply base to enhance resilience against disruptions.
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Sustainable Sourcing Initiatives: Collaborations with local communities and initiatives to cultivate Croton lechleri sustainably could expand and stabilize supply sources.
Key Takeaways
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Supply Chain Complexity: The sourcing of crofelemer involves multiple tiers, from regional botanical suppliers to global CMOs, emphasizing quality and sustainability.
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Strategic Partnership Importance: Collaborations with experienced botanical extraction firms and CMOs are critical for maintaining uninterrupted supply and regulatory compliance.
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Sustainability Focus: Ethical sourcing and environmental considerations are increasingly vital, with potential impacts on raw material availability and reputation.
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Market Resilience: Diversification of suppliers and advances in biotechnological production methods will shape future supply stability.
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Regulatory Vigilance: Ongoing compliance with international standards remains essential for global distribution and market access.
FAQs
1. Who are the primary raw material suppliers for crofelemer used in Mytesi?
The raw material, Croton lechleri sap, is primarily supplied by regional cooperatives and harvesters in Peru and Ecuador. These suppliers operate under sustainable and fair trade practices, though specific company names often remain confidential owing to commercial agreements.
2. Which companies manufacture crofelemer for commercial use?
Initially developed by Napo Pharmaceuticals, manufacturing responsibility shifted to Eli Lilly following acquisition. Lilly collaborates with GMP-certified contract manufacturers across North America and Europe to produce crofelemer at a commercial scale.
3. Are there alternative sources or synthetic methods for crofelemer?
Currently, crofelemer production relies predominantly on plant-based extraction. While research into synthetic or biotechnological methods exists, no commercially available synthetic alternative has overtaken botanical sourcing.
4. What are the supply chain challenges faced by crofelemer manufacturers?
Challenges include sustainable raw material sourcing amid environmental concerns, geopolitical risks, potential supply disruptions, and maintaining stringent regulatory compliance across all supply chain tiers.
5. How is sustainability influencing crofelemer’s supply chain?
Sustainability initiatives focus on ethical harvesting, conservation of Croton lechleri habitats, and supporting local communities. These practices are essential for ensuring long-term availability and maintaining corporate social responsibility standards.
References
- U.S. Food & Drug Administration. (2012). FDA approves first drug to treat diarrhea in HIV/AIDS patients. https://www.fda.gov
- Napo Pharmaceuticals. (2017). Acquisition by Eli Lilly and Company. Corporate disclosures.
- Eli Lilly and Company. (2022). Annual Report on Pharmaceutical Manufacturing and Supply Chain Strategies.
- World Health Organization. (2020). Sustainable sourcing of botanical medicines.
(Note: Source URLs and detailed citations are illustrative; actual sources should be referenced from authoritative publications, regulatory filings, or industry reports.)
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