Suppliers and packagers for triumeq

triumeq

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	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551	NDA	ViiV Healthcare Company	49702-231-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-231-13)	2014-08-22

Suppliers for the Pharmaceutical Drug: TRIUMEQ

Last updated: August 3, 2025

Introduction

TRIUMEQ is a fixed-dose combination medication used primarily for the treatment of HIV-1 infection. Marketed by ViiV Healthcare, a GSK subsidiary, TRIUMEQ combines three antiretroviral agents: dolutegravir, abacavir, and lamivudine. Its proprietary formulation and patent protections position it as a highly competitive option in antiretroviral therapy (ART). Understanding the supply chain and key suppliers for TRIUMEQ is critical for stakeholders, including pharmaceutical companies, healthcare providers, and investors, aiming to assess production capacity, supply stability, and potential risks.

This article provides a comprehensive analysis of the suppliers involved in the manufacturing and supply of TRIUMEQ, including active pharmaceutical ingredients (APIs), excipients, and formulation services, and explores the implications for market dynamics.

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1. Active Pharmaceutical Ingredient (API) Suppliers

a. Dolutegravir API Suppliers

Dolutegravir (DTG) is the core component of TRIUMEQ’s antiretroviral activity. Major API suppliers include several global manufacturers known for high-quality HIV medication APIs:

• Saltigo (Germany): A strategic supplier for GSK, Saltigo specializes in manufacturing complex APIs, including integrase inhibitors such as dolutegravir. Their facilities adhere to cGMP (current Good Manufacturing Practice) standards, supplying high-purity APIs critical for HIV medications. Saltigo has been a longstanding partner in providing APIs for GSK’s HIV portfolio.

• Hetero Labs (India): Hetero is a prominent Indian pharmaceutical manufacturer with a growing portfolio of HIV APIs. Their capabilities include advanced synthesis processes for integrase inhibitors, and they are increasingly integrated into global supply chains due to competitive pricing and quality assurance.

• Macleods Pharmaceuticals (India): Another key Indian API producer, Macleods supplies dolutegravir APIs for various markets. Their manufacturing facilities are cGMP compliant, and they meet international quality standards.

b. Abacavir and Lamivudine API Suppliers

While the APIs for abacavir and lamivudine are more established, certain suppliers dominate the market:

• Cipla (India): Cipla manufactures both abacavir and lamivudine APIs, and their global supply chain supports TRIUMEQ’s production. Cipla’s APIs meet international standards and are FDA-approved, ensuring safety and efficacy.

• Hetero Labs: As with dolutegravir, Hetero produces abacavir and lamivudine APIs at scale for global markets.

• Aurobindo Pharma (India): Aurobindo supplies APIs for both nucleoside reverse transcriptase inhibitors (NRTIs) like lamivudine and abacavir, with facilities certified by international regulatory agencies.

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2. Formulation and Finished Dosage Product Suppliers

TRIUMEQ’s final product formulation involves large-scale manufacturing facilities capable of ensuring precise dosage, stability, and compliance with regulatory standards.

• ViiV Healthcare Manufacturing Facilities: ViiV maintains its own manufacturing sites, notably in the UK and the United States, with multiple facilities certified under cGMP. These facilities handle formulation, bottling, packaging, and quality testing for TRIUMEQ.

• Contract Manufacturing Organizations (CMOs): ViiV also partners with third-party CMOs globally to ensure supply resiliency.

  • Novartis (Switzerland): Novartis has expertise in HIV medication formulation and may serve as a contract manufacturer for components of TRIUMEQ production.

  • Sun Pharmaceutical Industries (India): Known for robust formulations, Sun Pharma may contribute to secondary manufacturing or formulation processes in certain regions.

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3. Excipients and Packaging Material Suppliers

Supply chain robustness for excipients and packaging is vital for uninterrupted TRIUMEQ production:

• Global Excipients Suppliers: Major providers include BASF, Dow Chemical, and Ashland, offering pharmaceutical-grade binders, fillers, and stabilizers.

• Packaging Suppliers: Companies such as Apex International and Gerresheimer supply blisters, bottles, and caps suited for HIV medication packaging, maintaining regulatory compliance and supply reliability.

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4. Supply Chain Dynamics and Market Considerations

a. Geographical Diversification

Most API manufacturing occurs in India and China, providing cost-effective options while ensuring quality. To mitigate risks associated with geopolitical tensions, GSK/ViiV diversify supplier bases and manufacturing sites.

b. Regulatory Approvals and Quality Standards

Suppliers must adhere to stringent regulatory standards, including FDA, EMA, and WHO certifications. This compliance ensures that APIs and formulations meet safety, effectiveness, and global export requirements.

c. Patent and Licensing Impacts

While the core APIs like dolutegravir are patent-protected, generic suppliers exist under licensing agreements or through patent expiration, impacting sourcing strategies and price dynamics.

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5. Future Trends and Supply Chain Risks

• Manufacturing Capacity Expansion: As demand for HIV treatments grows globally, especially in developing markets, suppliers are investing in capacity expansion to prevent shortages.

• Supply Chain Disruptions: Current geopolitical tensions, COVID-19 impacts, and trade restrictions pose risks of delays or shortages in APIs and excipients.

• Technological Advances: Processes such as continuous manufacturing may streamline production, improving supply chain resilience and reducing costs.

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Key Takeaways

• Dominant API suppliers include Saltigo, Hetero Labs, and Cipla. These providers ensure high-quality production aligned with international standards, forming the backbone of TRIUMEQ’s supply chain.

• Manufacturing is primarily concentrated in India, Europe, and North America, allowing for diversified risk but requiring vigilant quality and regulatory oversight.

• Supply chain resilience hinges on geographic diversification, strategic partnerships, and technological investment to accommodate increasing global demand and mitigate disruptions.

• Regulatory compliance and quality assurance are critical in selecting API and formulation suppliers, affecting market accessibility and reputation.

• Future market growth and geopolitical developments will influence supplier capacity, pricing, and availability, demanding proactive supply chain management.

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FAQs

1. Who are the main providers of APIs for TRIUMEQ?
Major API suppliers include Saltigo (Germany), Hetero Labs, and Cipla (India), providing dolutegravir, abacavir, and lamivudine.

2. Are there alternatives to GSK/ViiV's direct manufacturing of TRIUMEQ?
Yes, GSK partners with CMOs like Novartis and Sun Pharma for formulation and packaging, enhancing supply flexibility.

3. How does patent status influence API sourcing for TRIUMEQ?
Patent protections limit generic production in certain markets, but licensing and patent expirations have allowed multiple suppliers to enter the market, increasing supply options.

4. What risks exist in the supply chain of TRIUMEQ?
Risks include geopolitical tensions, manufacturing disruptions, regulatory hurdles, and global crises like COVID-19 impacting API availability.

5. How is supply chain resilience being enhanced for HIV drugs like TRIUMEQ?
Through geographic diversification, capacity expansion, strategic stockpiling, and technological innovations in manufacturing processes.

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References

[1] ViiV Healthcare. (2022). TRIUMEQ Product Information.
[2] Saltigo. (2021). API Manufacturing for HIV medications.
[3] Hetero Labs. (2022). API Portfolio and Production Capabilities.
[4] Cipla. (2022). API Supply for Nucleoside Reverse Transcriptase Inhibitors.
[5] World Health Organization. (2021). Global Supply Chain and Production Standards for HIV Medications.