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Suppliers and packagers for TRIUMEQ PD
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TRIUMEQ PD
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 | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413 | NDA | ViiV Healthcare Company | 49702-258-37 | 1 KIT in 1 CARTON (49702-258-37) * 90 TABLET, FILM COATED in 1 BOTTLE (49702-272-59) | 2022-03-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TRIUMEQ PD
Introduction
In the pharmaceutical landscape, understanding the supply chain for critical medications like TRIUMEQ PD (a formulation used in HIV treatment) is fundamental for stakeholders, including healthcare providers, distributors, and investors. TRIUMEQ PD, developed by ViiV Healthcare, combines dolutegravir, abacavir, and lamivudine, and is prescribed as a once-daily antiretroviral therapy (ART). Recognizing its suppliers, manufacturers, and distribution channels can reveal insights into market stability, regulatory compliance, and strategic partnerships.
Manufacturers of TRIUMEQ PD Components
ViiV Healthcare’s Role
ViiV Healthcare, a joint venture majority owned by GSK, is the sole producer of TRIUMEQ PD. The company oversees the manufacturing, quality assurance, and distribution processes, ensuring compliance with international regulatory standards (FDA, EMA, etc.) [1]. The original formulations are produced in facilities equipped with advanced pharmaceutical manufacturing processes.
Component Suppliers
TRIUMEQ PD combines three active pharmaceutical ingredients (APIs): dolutegravir, abacavir, and lamivudine, each sourced from specialized suppliers:
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Dolutegravir (DTG):
GSK, ViiV Healthcare's parent, manufactures and supplies dolutegravir, ensuring consistent drug purity and supply stability. GSK operates multiple API synthesis facilities that adhere to Good Manufacturing Practices (GMP) [2]. -
Abacavir:
This nucleotide reverse transcriptase inhibitor is supplied by multiple API manufacturers, including Mylan (now part of Viatris) and Apotex, which produce high-purity abacavir suitable for pharmaceutical use. ViiV Healthcare may also source from these or other qualified suppliers to ensure redundancy. -
Lamivudine:
Major API producers like Cadila Healthcare and Hetero Labs supply lamivudine, which ViiV integrates into its formulations. Their production facilities meet international regulatory standards to assure drug quality.
Formulation and Packaging Partners
While ViiV Healthcare controls formulation development, packaging and final product assembly often involve third-party CDMOs (Contract Development and Manufacturing Organizations). These partners are selected based on their capacity, compliance, and logistical capabilities. Regulatory authorities frequently require documentation of these partnerships for market approvals [3].
Distribution Network and Key Suppliers
Distribution Strategists
ViiV Healthcare employs a comprehensive global distribution network to ensure TRIUMEQ PD's availability in diverse markets—especially in low- and middle-income countries (LMICs). Key players include:
-
McKesson Corporation:
North America’s primary distributor, ensuring supply chain integrity and timely delivery. -
Express Scripts and CVS Health:
These pharmacy benefit managers (PBMs) distribute TRIUMEQ PD in retail settings, coordinating with healthcare providers. -
Local Distributors in LMICs:
Initiatives like the Medicines Patent Pool (MPP) facilitate licensing agreements that allow generic manufacturers to produce TRIUMEQ PD in developing countries [4].
Generic Manufacturers
Following patent expiration or licensing agreements, various generic manufacturers have been authorized or are eligible to produce TRIUMEQ PD, increasing access. Notable licenses include:
-
Viatris (Mylan's successor):
Licensed to produce generic versions in several countries. -
Hetero Labs and Mylan:
Active in markets where patent barriers are waived or expired, providing affordable alternatives.
Supply Chain Challenges
Disruptions in raw material supply, geopolitical issues, and manufacturing caps can impact the stability of TRIUMEQ PD’s supply chain. The COVID-19 pandemic, for example, spotlighted vulnerabilities in API production and distribution logistics [5].
Regulatory and Voluntary Licensing
ViiV Healthcare has entered multiple licensing agreements to promote wider access to TRIUMEQ PD:
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Medicines Patent Pool (MPP):
Facilitates voluntary licenses allowing qualified generic manufacturers to produce TRIUMEQ PD in eligible countries, bolstering supply and affordability [4]. -
WHO Prequalification:
Some generic versions have received WHO prequalification, indicating adherence to quality standards, enabling procurement by global health agencies.
Future Outlook and Strategic Considerations
-
Supply Chain Diversification:
To mitigate risks, ViiV and associated manufacturers are expanding API sourcing and manufacturing footprint globally. -
Localization of Production:
Increasing licensing and local manufacturing can improve access, especially in resource-limited settings. -
Sustainability and Regulatory Harmonization:
Enhanced adherence to GMP and regulatory standards across supplier countries remains critical to maintaining supply integrity.
Key Takeaways
- ViiV Healthcare is the sole producer of TRIUMEQ PD, controlling API sourcing, formulation, and distribution.
- APIs are sourced from multiple qualified suppliers, with some APIs (dolutegravir, abacavir, lamivudine) produced by renowned manufacturers like GSK, Mylan, Apotex, Cadila, and Hetero.
- Global distribution is managed through a network of regional wholesalers, PBMs, and licensed generic manufacturers—facilitating access in both high-income and LMIC markets.
- Strategic licensing initiatives, such as those by the MPP, enhance generic manufacturing, thereby improving supply stability and affordability.
- Supply chain risks include raw material shortages, geopolitical issues, and manufacturing disruptions; proactive diversification and licensing can mitigate these risks.
FAQs
1. Who manufactures the active ingredients in TRIUMEQ PD?
ViiV Healthcare primarily manufactures and sources APIs like dolutegravir internally, while abacavir and lamivudine APIs are supplied by multiple global manufacturers, including Mylan, Apotex, Cadila, and Hetero.
2. Are there generic versions of TRIUMEQ PD available?
Yes, through licensing agreements with the Medicines Patent Pool, multiple generic manufacturers produce TRIUMEQ PD in various countries, enhancing access and affordability.
3. How does supply chain stability affect TRIUMEQ PD availability?
Disruptions in API supply, manufacturing delays, and logistic challenges can lead to shortages, impacting patient treatment continuity, especially in resource-limited settings.
4. What role do regulatory agencies play in the supply of TRIUMEQ PD?
Regulatory bodies like the FDA, EMA, and WHO facilitate approval processes, prequalification, and quality assurance, ensuring the safety and efficacy of both branded and generic formulations.
5. What strategies are in place to ensure ongoing supply of TRIUMEQ PD?
ViiV Healthcare employs diversified sourcing, licensing agreements, regional manufacturing, and robust distribution networks to maintain supply continuity amidst global challenges.
References
- ViiV Healthcare Official Website. (2023). Product portfolio and manufacturing insights.
- GSK Annual Report. (2022). API Production and Quality Assurance.
- U.S. Food and Drug Administration. (2023). Manufacturing guidelines for HIV drugs.
- Medicines Patent Pool. (2023). Licensing agreements for TRIUMEQ PD.
- WHO. (2022). Global supply chain disruptions and impact on essential medicines.
This comprehensive overview underscores the crucial supplier network underpinning TRIUMEQ PD, highlighting its manufacturing, licensing, and distribution channels essential for ensuring worldwide access.
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