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Suppliers and packagers for edurant
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edurant
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022 | NDA | Janssen Products, LP | 59676-278-01 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-278-01) | 2011-05-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Edurant (Rilpivirine)
Introduction
Edurant, with the generic name rilpivirine, is an antiretroviral medication primarily prescribed for treating HIV-1 infections. Manufactured by Johnson & Johnson, Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that forms a critical component of combination antiretroviral therapy (cART). Given the global demand for HIV treatments, a diverse network of suppliers and manufacturers contribute to the production and distribution of rilpivirine. This article offers a comprehensive overview of the primary suppliers for Edurant, analyzing their roles, manufacturing capacities, and the pharmaceutical supply chain dynamics.
Global Manufacturing Landscape for Rilpivirine
Johnson & Johnson (Janssen Pharmaceuticals)
Role and Position
Johnson & Johnson’s Janssen Pharmaceuticals is the originator and sole patent holder for Edurant. The company is responsible for the manufacturing, marketing, and distribution of rilpivirine-based formulations globally, particularly in North America, Europe, and select Asian markets.
Manufacturing Capabilities
Janssen maintains multiple manufacturing facilities optimized for active pharmaceutical ingredient (API) synthesis and finished dosage forms. Their extensive R&D and production infrastructure allow for high-quality production adhering to Good Manufacturing Practices (GMP). These facilities are often located in the United States, Europe, and Asia.
Supply Chain & Distribution
Janssen’s direct supply chain manages regulatory compliance and quality assurance, ensuring consistent availability of Edurant worldwide. Their distribution channels encompass both developed-region markets and lower-income nations through partnerships with global healthcare organizations.
API Suppliers and Contract Manufacturing Organizations (CMOs)
While Janssen primarily produces rilpivirine in-house, the global supply chain extends through collaboration with external API suppliers and CMOs. The complex synthesis of rilpivirine’s API necessitates specialized chemical manufacturing, often under strict confidentiality and quality standards.
Major API Suppliers
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Chinese Manufacturers
China hosts several API producers that supply intermediates and final APIs used in rilpivirine production. Companies such as Qilu Pharmaceutical, Hubei Topfond Pharmaceutical, and Shanghai Desano Biotech are capable of producing high-grade APIs in compliance with international regulations. These firms export to major pharmaceutical companies worldwide, often under contract manufacturing agreements. -
Indian API Suppliers
India's pharmaceutical sector, known for its generics manufacturing prowess, supplies APIs to global markets, including rilpivirine intermediates. Firms like Glenmark and Cipla have participated in the supply chain, either directly or via third-party CMOs. -
Other Asian Suppliers
Manufacturers in South Korea and Southeast Asia also contribute to the API supply chain, offering high-quality chemical synthesis and scale-up capacity.
Contract Manufacturing Organizations (CMOs)
CMOs play a vital role in the production of both APIs and finished dosage forms. Several prominent CMOs involved in rilpivirine production include:
- Samsung BioLogics (South Korea): Known for large-scale biologics manufacturing but also engaged in small molecule API synthesis.
- WuXi AppTec (China): Provides comprehensive contract development and manufacturing services, including small molecule APIs.
- Lonza (Switzerland): Offers custom synthesis and manufacturing for complex molecules, with capacity for high-purity APIs.
- Catalent (USA): Specializes in formulation and fill-finish services for finished dosage forms, including HIV medications.
Many of these CMOs operate under strict confidentiality agreements and are often suppliers to Johnson & Johnson or other major pharmaceutical firms.
Regional Distributors and Generic Manufacturers
In addition to original manufacturers, regional and generic pharmaceutical companies produce rilpivirine-based products, often under license or through intellectual property agreements. These include:
- Medsure and Mylan: Known to produce generic formulations after patent expiration or under licensing agreements.
- Cameo Pharmaceuticals: Engages in manufacturing and supplying rilpivirine generics in developing markets.
- Aurobindo Pharma and Hetero Labs: Indian generics manufacturers that produce rilpivirine formulations for low and middle-income countries (LMICs).
Supply Chain Challenges and Considerations
- Regulatory harmonization: Ensuring API suppliers meet international quality standards (e.g., US FDA, EMA) is crucial for maintaining supply integrity.
- Manufacturing capacity: Global demand fluctuations necessitate scalable production capacity, which can be limited by raw material availability.
- Geopolitical factors: Trade policies, export restrictions, and geopolitical tensions may impact supply chains, especially those reliant on Chinese and Indian manufacturers.
- Intellectual property rights: Patent protections influence licensing agreements and the entry of generic manufacturers into different markets.
Strategic Implications for Stakeholders
- For pharmaceutical companies: Managing a diversified supplier base reduces risks associated with supply disruptions. Establishing relationships with multiple API manufacturers enhances supply chain resilience.
- For healthcare providers: Reliable sourcing ensures uninterrupted patient access to Edurant, critical in HIV management.
- For policymakers: Supporting local manufacturing capabilities can improve access and reduce dependency on imports.
Key Takeaways
- Edurant (rilpivirine) is predominantly manufactured by Johnson & Johnson, with the company overseeing global distribution and quality assurance.
- The API supply chain involves key Chinese, Indian, and other Asian manufacturers capable of high-quality chemical synthesis.
- Contract manufacturing organizations in South Korea, China, and Europe support API and formulation scale-up, enabling reliable supply.
- The supply chain faces challenges including regulatory compliance, geopolitical tensions, and capacity constraints—necessitating strategic supplier diversification.
- Regional generic manufacturers play a vital role in expanding access in low-resource settings, contingent on licensing and patent statuses.
FAQs
1. Who are the primary manufacturers of rilpivirine API?
Major API manufacturing countries include China and India, with companies like Qilu Pharmaceutical and Glenmark playing significant roles.
2. Does Johnson & Johnson rely on external suppliers for rilpivirine production?
While Janssen produces rilpivirine in-house, it collaborates with external API suppliers and CMOs for capacity expansion and supply chain diversification.
3. Are there generic alternatives to Edurant?
Yes, several Indian and Chinese companies produce generic rilpivirine formulations, often under licensing agreements or once patents expire.
4. What are the main supply chain risks associated with rilpivirine?
Risks include manufacturing disruptions, regulatory hurdles, geopolitical conflicts, and raw material supply shortages.
5. How does the global supply chain affect access to HIV medication?
A robust and diversified supply chain ensures consistent medication availability, but disruptions can lead to shortages impacting patient care, especially in LMICs.
References
- Johnson & Johnson official website – Product information and manufacturing overview.
- World Health Organization (WHO) – Global procurement and supply chain reports for antiretroviral medicines.
- United States Food and Drug Administration (FDA) – Approved bulk drug manufacturers database.
- Pharmaceutical Technology – Articles on contract manufacturing and global API supply chains.
- Industry reports – Market analysis of HIV medication manufacturing and supply chain dynamics [e.g., IQVIA, EvaluatePharma].
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