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Suppliers and packagers for JULUCA
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JULUCA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192 | NDA | ViiV Healthcare Company | 49702-242-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13) | 2017-11-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Juluca
Introduction
Juluca is a fixed-dose combination antiretroviral therapy (ART) designed for the treatment of HIV-1 infection. Approved by the FDA in 2017, Juluca combines dolutegravir and rilpivirine in a single daily tablet, offering an effective, convenient option for patients requiring maintenance therapy. As a combination drug, its supply chain involves multiple critical stakeholders, including active pharmaceutical ingredient (API) manufacturers, finished dosage form (FDF) producers, packaging firms, and distribution channels. Understanding the supplier landscape for Juluca is vital for stakeholders assessing drug availability, supply security, and potential bottlenecks. This article provides a comprehensive analysis of the key suppliers involved in the manufacturing and distribution of Juluca — from raw material sources to finished product distributors.
Active Pharmaceutical Ingredient (API) Suppliers
1. Dolutegravir API Suppliers
Dolutegravir, an integrase strand transfer inhibitor, is a central component of Juluca. Its production involves complex chemical synthesis, requiring specialized API manufacturers:
- Vega Pharma: A prominent supplier of dolutegravir API, with manufacturing facilities in India and China, supplying both generic and branded APIs globally.
- Hetero Labs: An Indian company recognized for its expertise in HIV drug APIs and active engagement in bulk API production for dolutegravir.
- Mitsubishi Tanabe Pharma Corporation: A Japanese research-based pharmaceutical company that produces high-purity APIs, including dolutegravir, primarily for the Asian market.
2. Rilpivirine API Suppliers
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) critical to Juluca's formulation:
- Fulian Pharmaceutical: Based in China, Fulian supplies rilpivirine API to major global pharmaceutical companies, backed by rigorous WHO and FDA Good Manufacturing Practice (GMP) compliance.
- Hetero Labs: Also a key rilpivirine API supplier, leveraging its established manufacturing infrastructure in India.
- Chinese API Manufacturers: Several other Chinese firms, such as Zhaoyan Pharmaceutical, have entered the rilpivirine API space, expanding supply options.
Finished Dosage Form (FDF) Production
3. Contract Manufacturing Organizations (CMOs)
Once APIs are acquired, FDF manufacturing takes place in facilities that ensure proper formulation, quality control, and regulatory compliance:
- Glenmark Pharmaceuticals: An Indian pharmaceutical company with GMP-certified facilities capable of producing Juluca's dosage form, primarily for markets in Asia, Latin America, and emerging regions.
- Mylan (a Viatris subsidiary): Provides contract manufacturing services, with facilities specialized in HIV antiretrovirals, including fixed-dose combinations like Juluca.
- Aurobindo Pharma: Indian CMO with capacity to produce high-quality HIV combination drugs, meeting stringent international standards.
4. Packaging and Labeling
Packaging suppliers include firms specializing in pharmaceutical blisters, bottles, and labeling:
- BD (Becton, Dickinson and Company): Provides primary packaging components, including blister packs used in Juluca distribution.
- Dragonite Packaging: An Indian packaging specialist involved in labeling and secondary packaging of antiretroviral medicines, adhering to quality standards.
Distribution and Supply Chain Partners
Juluca's distribution is managed by a network of logistics providers to ensure compliance with Good Distribution Practices (GDP). Major pharmaceutical distributors and wholesalers include:
- McKesson Corporation: US-based distributor with extensive HIV medication supply logistics, ensuring the drug’s availability to healthcare providers.
- Fresenius Kabi: Distributor for HIV medications in Europe, Latin America, and Asia, ensuring timely supply for patient needs.
- PharmaLink: Global supply chain solutions provider that manages procurement, distribution, and inventory management for HIV medications, including Juluca.
Quality and Regulatory Considerations
Suppliers of Juluca are subject to strict regulatory oversight by the FDA, EMA, and other regulatory bodies. API manufacturers are required to meet GMP standards, with periodic inspections ensuring ongoing compliance. Finished product manufacturers must demonstrate adherence to stability, bioequivalence, and quality control parameters.
In particular, the sourcing of APIs from India and China underscores the importance of rigorous supplier qualification processes, given past regulatory focus on supply chain integrity. Leading suppliers invest heavily in GMP certifications, quality audits, and continuous process improvements to maintain quality standards necessary for global distribution.
Market Dynamics and Supplier Trends
The global supply landscape for Juluca reflects a broader trend in antiretroviral drug manufacturing—diversification of production to mitigate risks associated with supply chain disruptions. The reliance on Indian and Chinese API manufacturers remains significant due to cost efficiencies, although recent regulatory scrutinies may influence sourcing decisions.
Moreover, patent expiries and the rise of generic equivalents have increased competition among API producers, impacting pricing and supply stability. Collaborations between pharmaceutical companies and contract manufacturers facilitate scale-up and ensure resource flexibility to meet demand fluctuations.
Conclusion
The supply chain for Juluca involves multiple tiers, from API production by firms like Vega Pharma, Hetero Labs, and Fulian Pharmaceutical to FDF manufacturing by established CMOs, and finally, logistics partners ensuring drug availability worldwide. The interdependence of these suppliers underscores the need for rigorous quality assurance, regulatory compliance, and strategic sourcing to secure a stable supply network. Stakeholders should continuously monitor supplier performance, geopolitical influences, and regulatory changes to mitigate risks associated with Juluca’s supply chain.
Key Takeaways
- API sourcing for Juluca predominantly relies on Indian and Chinese manufacturers with GMP certification, notably Hetero Labs (India) and Fulian Pharmaceutical (China).
- FDF production is managed by reputable CMOs such as Glenmark and Mylan, ensuring adherence to international quality standards.
- Packaging and distribution involve specialized firms and global logistics providers, crucial for maintaining drug integrity and availability.
- Regulatory oversight and supply chain diversification are vital in mitigating risks related to geopolitical issues, regulatory compliance, and raw material shortages.
- Continuous monitoring of supplier performance and regulatory alignment remains essential for ensuring uninterrupted access to Juluca across global markets.
FAQs
1. Who are the main API suppliers for Juluca?
The primary API suppliers include Hetero Labs and Vega Pharma for dolutegravir, and Fulian Pharmaceutical for rilpivirine, all based in India and China.
2. Are there alternative suppliers for Juluca’s APIs?
Yes, other Chinese and Indian manufacturers are increasingly certified to supply APIs under GMP standards, providing supply diversification.
3. Where is Juluca manufactured?
Juluca’s finished dosage forms are produced by contracted manufacturers such as Glenmark Pharmaceuticals and Mylan, primarily based in India.
4. How does supply chain regulation affect Juluca?
Strict GMP standards and regular regulatory inspections ensure API and FDF quality, but supply chain disruptions or regulatory actions can impact availability.
5. What role do logistics companies play in Juluca’s supply?
They ensure compliance with GDP regulations, manage inventory, and facilitate timely distribution to global markets, critical for maintaining continuous patient access.
References
- U.S. Food and Drug Administration (FDA). Juluca (dolutegravir and rilpivirine) tablets. [FDA Label]
- World Health Organization. Prequalification of Medicines Programme: HIV/AIDS.
- Pharma intelligence reports on antiretroviral supply chains.
- Company disclosures and annual reports of Hetero Labs, Vega Pharma, Fulian Pharmaceutical.
- Industry analyses from IQVIA and GlobalData.
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