ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE: Pharmaceutical manufacturers, suppliers, and distributors

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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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The combination of Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine forms a critical component of antiretroviral therapy (ART) regimens for HIV treatment. As demand for effective and accessible HIV medications continues to rise globally, identifying reliable suppliers of these active pharmaceutical ingredients (APIs) and finished formulations is essential for pharmaceutical companies, procurement agencies, and healthcare providers. This report explores the leading suppliers of these drugs, focusing on their manufacturing capabilities, market positioning, regulatory compliance, and global reach.

Overview of the Drugs

Abacavir Sulfate: An NRTI (nucleoside reverse transcriptase inhibitor), Abacavir blocks HIV replication. Its global importance stems from its inclusion in first-line combination therapies, especially in fixed-dose combinations (FDCs)[1].

Dolutegravir Sodium: An integrase strand transfer inhibitor (INSTI), Dolutegravir is favored for its potency, high barrier to resistance, and tolerability[2].

Lamivudine: Also an NRTI, Lamivudine is widely used for HIV and hepatitis B treatment, often in combination twice daily[3].

These drugs are frequently combined in single-tablet regimens supplied by various pharmaceutical manufacturers.

Leading Suppliers and Manufacturers

1. Global Active Pharmaceutical Ingredient (API) Producers

a. Viatris (formerly Mylan, Pfizer’s generics division)

Products & Capabilities: Viatris supplies both APIs and finished formulations of Abacavir, Dolutegravir, and Lamivudine, with extensive manufacturing capacity across India, the U.S., and Europe.
Market Reach: They are among the leading suppliers globally, distributing to developing and developed markets, including the WHO prequalified products for low-income countries.
Regulatory Compliance: Their APIs adhere to international standards, including approvals from the US FDA, EMA, and WHO prequalification.

b. Hetero Drugs Ltd. (India)

Products & Capabilities: Hetero is a key API supplier for Abacavir Sulfate, offering high-quality APIs approved for multiple global markets.
Market Reach: Extensive presence in Asia, Africa, and Latin America, supplying both APIs and finished dosage forms.
Regulatory Status: Achieved approvals from US FDA, EMA, and WHO.

c. Sun Pharmaceutical Industries Ltd.

Products & Capabilities: Offers APIs of Abacavir and Lamivudine, supported by rigorous quality processes.
Market Reach: Strong presence in India, with exports worldwide, including to the US and Europe.
Regulatory Compliance: US FDA ANDA approvals and WHO listings enhance credibility.

d. Mylan (now part of Viatris)

Products & Capabilities: A significant supplier for Abacavir, Dolutegravir, and Lamivudine APIs, with a broad product portfolio.
Market Reach: Global distribution, especially in low- and middle-income countries.
Regulatory Status: Recognized by WHO prequalification and regulators globally.

e. Cipla Limited

Products & Capabilities: Produces APIs and finished formulations for Lamivudine, Abacavir, and Dolutegravir.
Market Reach: Focused on emerging markets with a substantial share in Africa, Asia, and Latin America.
Regulatory Compliance: WHO prequalified, US FDA-approved manufacturing facilities.

2. Contract Manufacturing Organizations & OEM Suppliers

Many pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) to produce APIs and finished products, especially for bulk procurement. Key CMOs include:

Thermo Fisher Scientific: Provides manufacturing services for APIs, including Dolutegravir.
Aurobindo Pharma: Produces APIs and finished doses for HIV drugs, including Lamivudine and Abacavir.
Hospira (now part of Pfizer): Manufactures APIs for various HIV medications.

Engaging with CMOs often guarantees scalable production tailored to specific market needs.

Regulatory and Quality Considerations

For HIV drugs, especially in international donation and procurement programs, adherence to strict quality standards is non-negotiable. Suppliers with WHO prequalification, US FDA approval, or EMA certification are preferred. The inclusion of these drugs in Treatment Guidelines often depends on regulatory recognition of their manufacturing quality and consistent supply.

Regional Suppliers and Market Dynamics

In low- and middle-income countries (LMICs), India and China dominate API manufacturing, driven by low-cost production and expanding capacities. Indian API producers like Hetero, Aurobindo, Cipla, and Sun Pharma are prominent due to their compliance with international standards and strategic positioning.

In contrast, North American and European markets rely on domestic or patent-holding pharmaceutical companies, with Viatris being a primary supplier for many developed markets.

Emerging Trends and Future Outlook

Generic Market Expansion: The increasing prevalence of HIV underscores ongoing demand for affordable generics. Suppliers investing in capacity expansion and regulatory approvals will likely sustain and grow their market share.
Regulatory Harmonization: Efforts to streamline approvals (such as WHO prequalification) facilitate supply chain reliability, especially in LMICs.
Biosimilar and Fixed-Dose Formulations: The move towards combination therapies simplifies treatment regimens; suppliers producing FDCs are gaining prominence.
Supply Chain Resilience: Diversification of suppliers and strategic stockpiling are essential to mitigate disruptions observed during global crises like COVID-19.

Conclusion

The landscape for suppliers of Abacavir Sulfate, Dolutegravir Sodium, and Lamivudine is characterized by a handful of global leaders with extensive capacities, regulatory approvals, and regional reach. Indian manufacturers like Hetero, Cipla, and Sun Pharma, along with multinational companies such as Viatris, dominate supply chains due to their high-quality standards and competitive pricing. Strategic procurement should prioritize suppliers with WHO prequalification and US FDA approval to ensure regulatory compliance and supply security.

Key Takeaways

Market dominance: Indian API manufacturers are central to global HIV drug supply, supported by their WHO prequalification and manufacturing scale.
Regulatory compliance: Ensure suppliers have necessary approvals (WHO, US FDA, EMA) for quality assurance.
Supply chain resilience: Diversify sourcing from multiple suppliers, especially for critical HIV drugs.
Emerging markets: Low-cost APIs and FDCs from Indian producers meet growing demands in LMICs.
Future growth: Integration of combination therapies and biosimilars will shape supplier strategies.

FAQs

1. Who are the leading global suppliers for Abacavir Sulfate?
Indian manufacturers such as Hetero, Cipla, and Sun Pharma are prominent suppliers, with Viatris (formerly Mylan and Pfizer) being a major player in both APIs and finished formulations.

2. How important is WHO prequalification for HIV drug suppliers?
It’s critical for international procurement, ensuring quality and safety standards are met, especially in low-resource settings.

3. Are there regional variations in supplier dominance?
Yes, Indian and Chinese producers dominate the API market globally due to cost advantages, while North American and European firms focus more on finished formulations for developed markets.

4. What role do Contract Manufacturing Organizations play in supplying these drugs?
CMOs expand manufacturing capacity, enable customization, and help maintain supply continuity while adhering to regulatory standards.

5. How might the market evolve in response to global health challenges?
Supply chain diversification, increased capacity, and regulatory harmonization will remain priorities to ensure uninterrupted access to HIV medications worldwide.

References

[1] UNAIDS. "Global AIDS Update 2022."
[2] FDA. "Drug Approval Package for Dolutegravir."
[3] WHO. "Guidelines on HIV Treatment."

Suppliers and packagers for generic pharmaceutical drug: ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE