Share This Page
Suppliers and packagers for EDURANT PED
✉ Email this page to a colleague
EDURANT PED
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 PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016 | NDA | Janssen Products, LP | 59676-280-90 | 9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01) | 2024-03-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EDURANT (Rilpivirine) PED
Introduction
Edurant, the brand name for Rilpivirine, is an antiretroviral medication primarily used in the treatment of HIV-1 infection. Approved by the FDA in 2011, Edurant is marketed globally and forms a critical part of combination therapy to suppress HIV viral load. As an essential drug for managing HIV/AIDS, ensuring a reliable supply chain of Edurant is vital for healthcare providers and pharmaceutical companies. This report offers a comprehensive overview of the key suppliers for Edurant (Rilpivirine) PED, examining manufacturing origins, supply chain dynamics, and market players involved.
Manufacturers of Edurant (Rilpivirine)
1. Janssen Pharmaceuticals (J&J)
Overview:
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, developed and commercialized Edurant. As the original patent holder, Janssen is the primary manufacturer responsible for the production, marketing, and distribution of Rilpivirine-based products globally.
Manufacturing Facilities:
Janssen maintains manufacturing sites across multiple countries, notably in the United States and Europe, equipped with advanced pharmaceutical production capabilities conforming to Good Manufacturing Practice (GMP) standards [1].
Supply Chain Role:
Janssen supplies Edurant directly to major healthcare distributors, government procurement agencies, and international aid programs. Its strategic manufacturing ensures consistency in drug quality and availability.
2. Contract Manufacturing Organizations (CMOs)
Overview:
In recent years, Janssen has partnered with various contract manufacturing organizations to expand manufacturing capacity and mitigate supply risks. These CMOs produce Rilpivirine APIs and finished formulations under strict quality guidelines.
Key CMOs:
-
Hetero Labs (India):
Hetero is one of the leading CMOs involved in manufacturing Rilpivirine APIs for Janssen. The Indian pharmaceutical industry is a major global supplier of APIs, benefiting from lower production costs while maintaining high-quality standards [2]. -
Cipla (India):
Cipla manufactures finished pharmaceutical products, including formulations containing Rilpivirine, facilitating wider access in the developing world. -
Mundipharma and Others:
Additional CMOs registered in Europe and Asia contribute to diversifying supply sources.
Regulatory Approvals and Supply Chain Access
Janssen’s manufacturing sites are approved by global regulatory authorities including the FDA, EMA, and WHO prequalification programs. These approvals are critical for exporting Edurant to countries with stringent regulatory requirements.
The company maintains an extensive distribution network, including:
- Gilead’s Global Supply Chain: While Gilead is a competitor in HIV therapies, Janssen strategically partners with various distributors.
- UNICEF and Global Fund Procurement: Edurant has been procured through international organizations, particularly in low-income countries.
Market Dynamics and Supply Risks
The supply of Edurant hinges on:
- API Availability: Rilpivirine API production is concentrated among limited suppliers, exposing the supply chain to disruptions from manufacturing or regulatory issues.
- Regulatory Changes: Regulatory actions or complications at manufacturing sites can lead to supply shortages.
- Patent and Generic Competition: While Janssen retains exclusivity during patent periods, generic manufacturers are positioned to enter the market post-expiry, potentially expanding supply sources.
Emerging Suppliers and Market Opportunities
Post-patent expiration, generic pharmaceutical companies in India, China, and other jurisdictions are expected to manufacture Rilpivirine, increasing competition and supply security. Companies like Hetero, Aurobindo Pharma, and Mylan are actively engaged in Rilpivirine API or finished product development, signaling potential supply diversification [3].
Supply Chain Challenges and Recommendations
- Consolidation Risks: Dependency on few key manufacturing sites increases vulnerability. Developing multiple production sources is advisable.
- Quality Assurance: Rigorous quality controls across all manufacturing partners are essential for maintaining drug safety.
- Regulatory Strategy: Maintaining robust regulatory dossiers and continuous compliance is critical amidst evolving global standards.
- Forecasting and Inventory Management: Strategic stockpiles and demand forecasting mitigate supply interruptions.
Conclusion
Janssen Pharmaceuticals remains the principal supplier of Edurant (Rilpivirine), leveraging internal manufacturing and strategic partnerships with CMOs to meet global demand. The evolving landscape, marked by patent expirations and emerging generic manufacturers, suggests increased supply diversification ahead. Stakeholders should monitor manufacturing quality, regulatory developments, and market entrants to secure a reliable supply chain for Edurant.
Key Takeaways
- Primary supplier: Janssen Pharmaceuticals, leveraging GMP-certified manufacturing facilities worldwide.
- Secondary suppliers: Contract manufacturers like Hetero Labs and Cipla, mainly from India, are critical for API and finished formulations.
- Supply risks: Concentrated manufacturing and API sourcing pose risks; diversifying suppliers remains crucial.
- Market evolution: Patent expiries and generics will likely expand supply sources, improving accessibility.
- Strategic considerations: Supplier diversification, regulatory compliance, and quality assurance are vital for uninterrupted supply.
FAQs
1. Who is the main manufacturer of Edurant (Rilpivirine)?
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is the primary manufacturer responsible for Edurant globally.
2. Are there alternative suppliers for Rilpivirine API?
Yes. Several Indian and Chinese pharmaceutical manufacturers, such as Hetero Labs and Aurobindo Pharma, produce Rilpivirine APIs, especially post-patent expiry.
3. How does the supply chain ensure quality and compliance?
All manufacturing partners operate under GMP standards, and their facilities are approved by regulators like the FDA, EMA, and WHO.
4. What impact do patent expirations have on the supply of Rilpivirine?
Patent expiry opens the market to generic manufacturers, increasing production capacity, supply, and affordability.
5. What are the key risks facing Edurant supply?
Dependence on limited API sources, regulatory delays, manufacturing disruptions, and geopolitical factors pose supply risks.
References
[1] Johnson & Johnson. "Janssen’s manufacturing capacities." Janssen Pharmaceuticals, 2022.
[2] Indian Pharmaceutical Association. "India as a global API manufacturing hub." IPA Industry Report, 2022.
[3] Medicines for Europe. "Generic and biosimilar market trends." Market analysis report, 2022.
More… ↓
