Suppliers and packagers for generic pharmaceutical drug: CROFELEMER

CROFELEMER

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

Suppliers for the Pharmaceutical Drug: Crofelemer

Last updated: August 7, 2025

Introduction

Crofelemer is a novel botanical-derived pharmaceutical used primarily to treat diarrhea in patients with HIV/AIDS and certain gastrointestinal conditions. As a complex, biopharmaceutical product, crofelemer's supply chain involves specialized manufacturing processes, intellectual property considerations, and regulatory compliance. Identifying key suppliers—ranging from raw material providers to manufacturing partners—is essential for stakeholders aiming to ensure reliability, quality, and cost-effectiveness in the product lifecycle.

Manufacturing Company and Proprietary Status

Cytokinetics, an innovative biopharmaceutical firm, holds the rights to crofelemer, primarily commercialized by its partner, Napo Pharmaceuticals (now part of Salix Pharmaceuticals, a subsidiary of Gilead Sciences). Crofelemer's proprietary status entails strict control over its supply chain, requiring collaboration with licensed suppliers for raw materials and manufacturing services compliant with Good Manufacturing Practice (GMP).

Raw Material Suppliers

1. Botanical Source and Extraction

Crofelemer is derived from the latex of the Dragon's Blood tree (Croton lechleri), native to the Amazon rainforest. The active compound results from a complex extraction process that isolates proanthocyanidins and related polyphenolics.

• Plant Material Supply: Suppliers must source Croton lechleri latex sustainably, adhering to environmental and ethical standards. While specific suppliers for C. lechleri latex are not publicly disclosed, reputable botanical extract suppliers worldwide often collaborate with forestry and agricultural partners in South America.

• Extraction and Purification: Contract manufacturing organizations (CMOs) with expertise in botanical extractions are used for processing, often sourced through specialized botanical extract companies with GMP certifications. Examples include Phytotech Labs and Associated British Foods (ABF), which provide botanical raw materials and extracts under strict quality controls.

2. Active Pharmaceutical Ingredient (API) Manufacturing

• Cytokinetics‘ API Production: Currently, crofelemer's API synthesis involves semi-synthesis from natural latex, with manufacturing carried out in cGMP-compliant facilities. While specific API suppliers are undisclosed, major CMOs globally capable of producing botanical-derived APIs include GSK's manufacturing facilities, Lonza, and Siegfried, all of which maintain high standards and deep experience in complex botanicals and biopharmaceuticals.

• Quality Certification: Suppliers must meet international standards such as ISO 9001, ISO 13485, and cGMP, ensuring purity, potency, and batch-to-batch consistency.

Manufacturing Partners and Commercial Supply

3. Contract Manufacturing Organizations

Given crofelemer's complexity and proprietary status, Cytokinetics collaborates with specialized CMOs for different manufacturing stages—extraction, formulation, and final drug product manufacturing.

• Formulation and Fill-Finish: Companies like Catalent, Patheon (a part of Thermo Fisher Scientific), and Lonza are common partners in drug formulation, capsule filling, and packaging.

• Large-Scale Production: Gilead Sciences, post-acquisition of Napo Pharmaceuticals, is likely involved in large-scale manufacturing, leveraging its established global manufacturing network for supply continuity.

4. Distribution and Storage

• Logistics partners specializing in cold chain and sensitive pharmaceuticals, such as DHL Global Forwarding and FedEx, manage distribution, ensuring product integrity from manufacturing sites to healthcare providers.

Regulatory and Supply Chain Considerations

• Supply Chain Transparency: Crofelemer's supply chain transparency is crucial given its botanical origin. Regulatory authorities, including the FDA and EMA, require comprehensive traceability of raw materials and manufacturing processes.

• Environmental and Ethical Sourcing: Suppliers are expected to comply with sustainability standards, such as FairWild or Organic certification, especially given the ecological sensitivity of the Amazon rainforest.

Key Players in the Crofelemer Supply Chain

Role	Notable Entities	Remarks
Botanical raw material supplier	No specific public disclosures; typically regional Amazon harvesters	Critical for sustainable sourcing
Extraction and API manufacturing	Custom CMOs (e.g., Lonza, Siegfried, GSK)	Possess botanical extraction expertise
Formulation and finished drug manufacturing	Catalent, Patheon, Lonza	Specialized in GMP-compliant formulation processes
Distribution	DHL, FedEx, local pharma distributors	Ensures cold chain integrity

Emerging Trends and Future Suppliers

The evolving landscape of botanical-derived pharmaceuticals suggests potential expansion of supplier networks, especially as demand for crofelemer grows for indications beyond HIV-associated diarrhea. Strategic sourcing from South American botanical suppliers and partnerships with sustainable harvesters will likely intensify to meet increasing global needs.

Conclusion

Crofelemer's supply chain hinges on a complex interplay between botanical raw material providers, specialized extraction and manufacturing partners, and global distribution networks. While public information is limited due to proprietary considerations, the focus on sustainability, quality assurance, and regulatory compliance remains paramount. Stakeholders should prioritize establishing transparent, ethical, and compliant relationships with raw material suppliers and CMOs to ensure consistent, high-quality supply.

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Key Takeaways

• Strategic sourcing of Croton lechleri latex is foundational, with an emphasis on sustainability and ethical harvesting practices.
• Specialized CMOs with botanical extraction expertise and GMP certification are critical for API and formulation manufacturing.
• Regulatory compliance and traceability are essential throughout the supply chain to meet global standards.
• Emerging partnerships with South American harvesters and extraction firms are likely to enhance raw material stability.
• Supply chain resilience depends on diversified sourcing and rigorous quality controls, especially amidst geopolitical and environmental challenges.

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FAQs

1. Who are the primary manufacturers producing crofelemer-related APIs?
Most proprietary details remain confidential; however, major global pharmaceutical contract manufacturers like Lonza, Siegfried, and GSK possess the capabilities for botanical extraction and API manufacturing, typically in collaboration with Cytokinetics or its partners.

2. Are there sustainable sourcing initiatives for Croton lechleri latex?
While publicly available information is limited, sustainable harvesting practices are increasingly emphasized, with certifications such as FairWild, supporting environmental conservation and fair trade.

3. Can other botanical suppliers produce crofelemer?
Potentially, but due to crofelemer's complex extraction and purification process, only suppliers with robust botanical extraction expertise and GMP compliance can manufacture suitable raw materials at the necessary quality standards.

4. What regulatory challenges exist for crofelemer supply chain management?
Ensuring traceability, compliance with environmental standards, and maintaining GMP standards across international suppliers pose significant regulatory challenges, particularly when sourcing from remote regions.

5. Is the supply chain of crofelemer vulnerable to environmental threats?
Yes. Deforestation, climate change, and geopolitical issues can disrupt raw material harvesting, underscoring the importance of diversified sourcing and sustainable practices.

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References

[1] Gilead Sciences. (2021). Crofelemer (Fulyzaq®) Prescribing Information.
[2] Cytokinetics. (2022). Pipeline and Product Portfolio.
[3] FairWild Foundation. (2023). Sustainable wild harvesting standards.
[4] Lonza Group. (2023). Botanical raw material manufacturing capabilities.