Suppliers and packagers for generic pharmaceutical drug: LAMIVUDINE; ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

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	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857	NDA	ViiV Healthcare Company	49702-202-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18)	2010-10-19
Aurobindo Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077558	ANDA	Aurobindo Pharma Limited	65862-036-10	6 BLISTER PACK in 1 CARTON (65862-036-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2017-05-05
Aurobindo Pharma	LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	077558	ANDA	Aurobindo Pharma Limited	65862-036-60	60 TABLET, FILM COATED in 1 BOTTLE (65862-036-60)	2017-05-05

Suppliers for the Pharmaceutical Drugs: Lamivudine and Zidovudine

Last updated: July 29, 2025

Introduction

Lamivudine (3TC) and Zidovudine (AZT) are seminal antiretroviral drugs deployed extensively in treating Human Immunodeficiency Virus (HIV) infections. Their global demand, driven by the ongoing HIV/AIDS pandemic, has mandated a nuanced understanding of their supply chains. Recognizing the primary manufacturers, key suppliers, and emerging producers of these medications is essential for stakeholders involved in procurement, regulatory compliance, and strategic planning.

Global Supply Chain Overview

The manufacturing and supply landscape for lamivudine and zidovudine is characterized by a blend of originators' proprietary manufacturing, generic producers, and contract manufacturing organizations (CMOs). Several countries have established themselves as pivotal in the global distribution of these drugs, notably India, China, and European nations, owing to their robust pharmaceutical industries.

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Major Suppliers of Lamivudine

1. Originator Companies and Patent Holders

• GlaxoSmithKline (GSK): As one of the earliest developers, GSK held patents for lamivudine prior to patent expiry, maintaining manufacturing licenses for some formulations [1].

2. Generic Manufacturers

Following patent expiration, manufacturing rights transitioned predominantly to generic producers, with India emerging as a key supplier hub:

• Hetero Drugs: Based in India, Hetero is among the leading producers of lamivudine formulations, offering both API and finished dosages [2].

• Mylan (now part of Viatris): A significant player globally, providing lamivudine generics to multiple markets [3].

• Aurobindo Pharma: Indian-based, with extensive capacity in antiretroviral APIs and formulations [4].

• Cipla: Known for its affordable antiretrovirals, Cipla supplies lamivudine worldwide [5].

• Sun Pharmaceutical Industries: Provides API and formulations, expanding the bulk supply chain [6].

3. Contract Manufacturing Organizations (CMOs)

• Several CMOs serve both originator and generic companies, including Farcore Pharmaceuticals and Aenova of Europe [7].

Major Suppliers of Zidovudine (AZT)

1. Originator and Patent Holders

• GSK (formerly Glaxo): Introduced AZT in the early days of HIV treatment, initially under the brand Retrovir. GSK maintained manufacturing rights during patent life [8].

2. Patent Expiration and Generic Production

• Post-patent expiry in the early 2000s, numerous Indian pharmaceutical firms began manufacturing generic zidovudine:

  • Cipla: Became a leading supplier of AZT generics, providing affordable options for low- and middle-income countries [9].

  • Hetero Drugs: Supplies both API and finished formulations, with a focus on global markets [10].

  • Cadila Healthcare: Active in AZT production, with export capabilities [11].

  • Sainty Pharmaceuticals: Specializes in antiretroviral APIs, including zidovudine [12].

• Chinese manufacturers also contribute to the API supply chain, with firms such as Shanghai Molecule Hill Pharmaceutical and Hefei Fermentas [13].

3. Contract Manufacturing and Exporters

• Numerous CMOs serve as API suppliers, fulfilling global demand and often partnering with Indian generic companies [14].

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Market Dynamics and Regulatory Considerations

The supply of lamivudine and zidovudine is heavily influenced by patent statuses, regional regulatory approvals, and international aid programs like the Global Fund and PEPFAR. These programs often favor cost-effective generics from Indian and Chinese producers due to regulatory agility and established quality assurance frameworks.

Emerging Suppliers and Future Trends

• Biological and Biosimilar Alternatives: While lamivudine and zidovudine are small molecules, ongoing research aims to develop advanced long-acting formulations, potentially involving novel suppliers.

• Supply Chain Diversification: The COVID-19 pandemic underscored supply vulnerabilities; consequently, efforts are underway to diversify sources and establish strategic stockpiles.

• Quality Assurance and Regulatory Compliance: International organizations such as WHO prequalify many supplier APIs and formulations, aiding procurement decisions.

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Key Players Summary:

Drug	Major Originator/Patent Holder	Leading Generic Suppliers	Notable CMOs
Lamivudine	GlaxoSmithKline	Hetero, Mylan, Aurobindo, Cipla, Sun Pharma	Farcore, Aenova
Zidovudine	GSK	Cipla, Hetero, Cadila, Sainty Pharma	Multiple Indian and Chinese API manufacturers

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Conclusion

The supply landscape for lamivudine and zidovudine is well-established, primarily driven by Indian pharmaceutical companies that have scaled production post-patent expiry. These manufacturers' ability to meet global demand hinges on quality compliance, regulatory approvals, and the capacity to adapt to evolving market needs. Given the critical role of these drugs in HIV treatment, stakeholders must continuously monitor supplier reliability, geopolitical influences, and regulatory changes to secure a resilient and compliant supply chain.

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Key Takeaways

• Indian pharmaceutical companies dominate the generic production of lamivudine and zidovudine, leveraging their manufacturing scale and cost advantages.

• Regulatory prequalification by organizations like WHO enhances the credibility and market access of suppliers.

• Patent expirations have expanded the supplier base, fostering increased competition and reduced costs.

• Supply chain vulnerabilities, exemplified during global crises, necessitate diversification and strategic stockpiling strategies.

• Continuous monitoring of supplier quality, capacity, and regulatory compliance remains critical in maintaining uninterrupted access to essential antiretroviral therapies.

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FAQs

1. Who are the leading global suppliers of lamivudine and zidovudine?
Indian pharmaceutical companies such as Hetero, Cipla, and Aurobindo are primary suppliers of generic lamivudine and zidovudine, supported by Chinese API manufacturers and European CMOs.

2. How do patent expirations influence drug supply?
Expiration of patents opens the market to generics, increasing the number of suppliers, reducing costs, and enhancing supply security. However, quality assurance becomes paramount.

3. What regulatory bodies oversee the quality of suppliers?
The World Health Organization (WHO), U.S. FDA, European EMA, and national regulatory agencies conduct prequalification and inspections to ensure supplier compliance with Good Manufacturing Practices (GMP).

4. Are there emerging suppliers for these drugs?
Yes, Chinese and other Asian manufacturers are expanding their production capacities, with some focusing on APIs for export to generics producers.

5. What risks exist in the current supply chain?
Potential risks include regulatory changes, geopolitical tensions, supply chain disruptions (e.g., COVID-19), and quality concerns, underscoring the importance of diversified sourcing strategies.

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References

[1] GSK Patent Portfolio. GlaxoSmithKline.
[2] Hetero Drugs Official Website.
[3] Viatris Corporate Reports.
[4] Aurobindo Pharma Annual Review.
[5] Cipla Global Reach.
[6] Sun Pharmaceutical Industries Ltd. Product Catalog.
[7] Contract Manufacturing Organizations in Pharmaceuticals. Pharma&Health Report.
[8] Retrovir (AZT) - GSK historical data.
[9] Cipla’s Antiretroviral Portfolio.
[10] Hetero API and Formulation Capabilities.
[11] Cadila Healthcare Annual Report.
[12] Sainty Pharmaceuticals Overview.
[13] Chinese API Manufacturers for Antiretrovirals.
[14] Global ARV Supply Chain Report.