Suppliers and packagers for ziagen

ziagen

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	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978	NDA	ViiV Healthcare Company	49702-222-48	1 BOTTLE in 1 CARTON (49702-222-48) / 240 mL in 1 BOTTLE	1999-01-28

Suppliers for the Pharmaceutical Drug: ZIAGEN

Last updated: July 30, 2025

Introduction

ZIAGEN (abacavir sulfate) is a critical antiretroviral medication used in the treatment of HIV-1 infection. Developed initially by GlaxoSmithKline (GSK), ZIAGEN serves as a cornerstone within combination therapy regimens. As the landscape of pharmaceutical supply chains becomes increasingly complex, understanding the suppliers behind ZIAGEN is vital for stakeholders—regulators, healthcare providers, and investors—who seek to ensure drug quality, supply stability, and compliance with international standards.

This report delineates the primary manufacturers, intermediaries, and supply chain partners for ZIAGEN, evaluates the geographical distribution of production facilities, and analyzes the factors influencing supplier selection.

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Manufacturers of ZIAGEN

GlaxoSmithKline (GSK)

Originally, GSK was the sole developer and manufacturer of ZIAGEN, holding the patent for abacavir until patent expiry and subsequent generic availability. As an innovator, GSK maintained a vertically integrated manufacturing process, encompassing active pharmaceutical ingredient (API) production, formulation, and packaging.

Post-patent expiry, GSK’s role transitioned largely into licensing and procurement, with the company retaining strategic control over manufacturing quality standards and supply chain oversight. GSK’s manufacturing facilities, located primarily in Europe and North America, adhere to Good Manufacturing Practices (GMP) recognized globally by the FDA and EMA.

Generic Manufacturers

Following patent expiration, multiple generic drug producers entered the ZIAGEN supply chain, expanding global access. Key generic suppliers include:

• Mylan/NOVARTIS: Known for their extensive antiviral portfolio, Mylan (now part of Viatris) produces abacavir tablets under strict quality standards.

• Hetero Labs (India): A significant player in the generic antiviral market, Hetero supplies abacavir API and finished formulations for broader distribution, particularly in emerging markets.

• Cipla Limited (India): A prominent generic manufacturer, Cipla produces abacavir-based formulations meeting WHO prequalification requirements.

• Aurobindo Pharma (India): Engaged in both API and finished dosage forms, Aurobindo supplies ZIAGEN-equivalent products globally.

API Suppliers

The production of high-quality abacavir API is central to the supply chain. The following are significant API suppliers:

• Hetero Labs: Supplies APIs to multiple generic manufacturers, with facilities compliant with GMP and WHO guidelines.

• Aurobindo Pharma: Produces API certified by regulatory authorities, ensuring quality for international markets.

• Sun Pharmaceutical Industries: Contributing to API supply, particularly for produce-demand in Asian markets.

• Dr. Reddy’s Laboratories: Another key API manufacturer with a focus on the antiviral segment.

Note: API sourcing often involves complex global procurement, with manufacturers often relying on multiple API suppliers to mitigate supply risks.

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Supply Chain and Distribution Partners

Once manufactured, ZIAGEN tablets are distributed through a network of distributors, wholesalers, and logistics providers who ensure timely supply to hospitals, clinics, and government health programs worldwide.

Major regional distributors include:

• McKesson Corporation (North America)
• Chemo Group (Europe, Latin America)
• Bid Pharma (Asia-Pacific)
• Pharmexx (Asia, Africa)

These entities coordinate tightly with GSK and generic manufacturers to meet demand and regulatory compliance.

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Geographical Distribution of Manufacturing

Global production of ZIAGEN and its API is distributed strategically to optimize costs, regulatory compliance, and supply resilience:

• Europe and North America: Manufacturing facilities primarily owned by GSK, adhering to stringent GMP standards.
• India: A hub for generic API and tablet production, with companies such as Hetero, Aurobindo, and Cipla dominating the market.
• Other Markets: Manufacturing may be conducted locally or through regional partners to meet local regulatory requirements and reduce logistics costs.

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Regulatory Considerations and Procurement Strategies

Manufacturers supplying ZIAGEN must comply with multiple regulatory standards, including the US FDA, EMA, WHO Good Manufacturing Practices, and respective national authorities. Rigorously monitored quality controls assess API purity, bioavailability, and batch consistency.

Procurement strategies often involve long-term supply agreements, dual sourcing, and strategic stockpiling to mitigate disruptions caused by geopolitical factors, manufacturing issues, or global crises like pandemics.

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Impact of Patent Expiry and Generic Competition

The patent expiration of ZIAGEN in several markets has exponentially increased supplier diversity and competitive pricing. This diminishes reliance on a single source, fostering price reductions and increased access, especially in resource-limited settings. However, it also introduces variability in supply quality and regulatory approval processes across differing jurisdictions.

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Emerging Trends and Future Outlook

• API Manufacturing Efficiency: Innovations in API synthesis, such as continuous manufacturing and greener processes, aim to improve yields and reduce costs.
• Supply Chain Transparency: Increased regulatory scrutiny demands more disclosure and traceability of API sources.
• Diversification of Suppliers: To counter supply risks, companies are expanding their supplier base and considering alternative manufacturers in emerging markets.

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Key Takeaways

• Multiple Suppliers: Post-patent expiration, ZIAGEN’s supply chain has diversified, with prominent manufacturers including generic firms like Hetero, Cipla, and Aurobindo, alongside original innovator GSK.
• Critical API Producers: API procurement primarily involves Hetero Labs, Aurobindo, and Sun Pharma, emphasizing quality compliance with international standards.
• Global Manufacturing hubs: Europe, North America, and India dominate production, with a focus on ensuring supply resilience.
• Strategic Distribution: Efficient logistics partners are vital for maximizing access, especially in low-resource settings.
• Regulatory Vigilance: Strict adherence to GMP standards and regulatory approvals underpin supplier credibility and product integrity.

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FAQs

1. Who are the leading manufacturers of ZIAGEN currently?
Post-patent expiry, key manufacturers include GSK (original supplier), complemented by generic producers such as Hetero Labs, Cipla, Aurobindo, and Sun Pharma, all meeting international quality standards.

2. Where is the API for ZIAGEN predominantly produced?
The API is mainly produced in India by companies like Hetero and Aurobindo, with additional manufacturing in Europe and North America, depending on regulatory and logistical considerations.

3. How do regulatory agencies influence ZIAGEN’s supply chain?
Strict GMP compliance mandated by agencies like the FDA and EMA ensures API quality and influences supplier selection, inspection, and ongoing quality assurance practices.

4. What risks exist within the ZIAGEN supply chain?
Risks include supply disruptions from API shortages, manufacturing quality lapses, geopolitical impacts, and regulatory compliance issues, necessitating diversified sourcing and strategic stockpiles.

5. How is the supply of ZIAGEN expected to evolve?
Continued competition, technological innovations in API synthesis, and expanded manufacturing capacity suggest enhanced supply resilience, affordability, and broader access.

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References

1. GlaxoSmithKline Official Website. ZIAGEN Product Information.
2. World Health Organization. Prequalification of Medicines.
3. U.S. Food and Drug Administration (FDA). Active Pharmaceutical Ingredient (API) Regulations.
4. Synthesis and manufacturing of abacavir API: Pharmaceutical Technology Reports.
5. Market analysis reports from IQVIA and GlobalData on antiretroviral drug supply.