Suppliers and packagers for epivir

epivir

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	EPIVIR	lamivudine	SOLUTION;ORAL	020596	NDA	ViiV Healthcare Company	49702-205-48	240 mL in 1 BOTTLE (49702-205-48)	2010-10-04
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564	NDA	ViiV Healthcare Company	49702-203-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-203-18)	2010-10-04
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564	NDA	ViiV Healthcare Company	49702-204-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13)	2010-10-04

Suppliers for the Pharmaceutical Drug: Epivir

Last updated: July 28, 2025

Introduction

Epivir, known generically as lamivudine, is an antiretroviral medication primarily used to treat HIV/AIDS and chronic hepatitis B. Its widespread clinical adoption hinges on a robust supply chain comprising multiple manufacturers and suppliers worldwide. Ensuring consistent procurement of Epivir requires understanding the key players involved in its production, the manufacturing landscape, and the regulatory framework governing its supply. This article provides an exhaustive analysis of the main suppliers and strategic considerations for stakeholders in the pharmaceuticals market.

Overview of Epivir and Its Market

Epivir (lamivudine) belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs). It was developed and brought to market by GlaxoSmithKline (GSK) in the late 1990s and remains a critical component of combination antiretroviral therapy (ART). Its essential role in HIV and hepatitis B treatment sustains steady demand, with global sales maintained through direct manufacturing and licensing agreements.

The global epivir market is characterized by patent expirations and increased manufacturing agreements with generic producers, which subsequently diversify the supplier base. The battle to maintain supply security involves both originator companies and generics manufacturers, especially in regions with high HIV prevalence like sub-Saharan Africa and Asia.

Major Suppliers of Epivir (Lamivudine)

1. GlaxoSmithKline (GSK)

As the original developer, GSK historically has been the primary supplier of Epivir. The drug was initially patented in the 1990s, but patent expiration in key markets has facilitated the emergence of generic competition. GSK continues to supply Epivir through its manufacturing facilities, although it now largely operates in the context of licensing and strategic collaborations.

Production Facilities:
GSK’s manufacturing plants are located across the UK, USA, and emerging markets, with facilities compliant with Good Manufacturing Practice (GMP) standards. The company’s focus has shifted toward R&D and strategic licensing, reducing direct supply dependence in certain markets.

Supply Strategy:
GSK maintains supply through direct production and licensing agreements with regional manufacturers, often in low- and middle-income countries, to meet local demands.

2. Indian Manufacturers

India is the epicenter of generic production for lamivudine, accounting for a significant share of the global supply, especially post-patent expiry. Several Indian pharmaceutical companies have become key suppliers:

• Hetero Drugs:
  One of India’s leading producers, Hetero has secured WHO prequalification for lamivudine and supplies the drug to various international organizations, including the Global Fund and UNICEF.

• Cipla:
  A major player in HIV medication manufacturing, Cipla produces generic lamivudine for global distribution, leveraging its extensive API (Active Pharmaceutical Ingredient) and finished-dose formulations.

• Mylan (now part of Viatris):
  Mylan has historically supplied generic lamivudine, with its manufacturing facilities globally approved, including WHO prequalified sites.

• Lupin:
  Specializes in generic formulations, including lamivudine, with a focus on expanding access in Asia and Africa.

Manufacturing Capabilities:
Indian manufacturers benefit from advanced API synthesis and formulation capabilities, extensive quality control protocols, and compliance with international standards such as US FDA and EMA approvals.

3. Chinese Manufacturers

China has emerged as a significant supplier of APIs for lamivudine, contributing substantially to global supply chains:

• Sino Biopharmaceutical
• North China Pharmaceutical Group (NCPC)

These firms supply APIs and finished formulations and have gained approvals from regulatory agencies in multiple countries.

Regulatory Landscape:
While Chinese suppliers are increasing their market share, regulatory stability and quality assurance remain pivotal for buyers.

4. Generic Manufacturers in Other Markets

Several regional manufacturers in Latin America, Southeast Asia, and Africa also produce lamivudine under licensing agreements, filling critical supply gaps, particularly where local production is prioritized to reduce dependence on imports.

Supply Chain Dynamics and Challenges

Patent Expiry and Generic Surge

The expiration of GSK’s lamivudine patent in 2005 for most major markets opened the floodgates to a proliferation of generic manufacturers, dramatically increasing supply and reducing prices.

Regulatory Harmonization

Manufacturers supply through a complex web of regulatory approvals from agencies such as the US FDA, EMA, WHO, and local authorities. WHO prequalification has become a key marker of supplier credibility, especially for procurement in low-resource settings.

Supply Risks

Primary risks include manufacturing disruptions, political instability, regulatory delays, and raw material shortages. Notably, the COVID-19 pandemic exposed vulnerabilities in global supply chains, leading to increased focus on diversified sourcing strategies.

Key Sources of API and Finished Dosage Supplies

Supplier Type	Notable Companies	Strategic Advantages	Regulatory Status	Market Focus
Original Developers	GSK	R&D capabilities, global manufacturing	Patented markets (expiring)	Global, mature markets
Indian Generics	Hetero, Cipla, Mylan, Lupin	Cost-effective production, WHO prequalified	WHO, US FDA approved	Africa, Asia, Latin America
Chinese APIs	Sino Biopharmaceutical, NCPC	Large API scale, competitive pricing	Various approvals	Asia, emerging markets

Regulatory and Quality Assurance

Suppliers must meet rigorous standards to access global markets. WHO prequalification plays a significant role in supplying to UN agencies and developing nations. Additionally, compliance with US FDA and EMA approvals signals adherence to high-quality standards, influencing procurement decisions.

Strategic Considerations for Stakeholders

• Quality Assurance:
  Prioritize suppliers with robust QA/QC mechanisms and WHO prequalification status.

• Diversity of Suppliers:
  Mitigate risks by diversifying sources across geographic regions and manufacturers.

• Cost and Supply Stability:
  Balance lower-cost generic suppliers with reliable, well-regulated manufacturing partners.

• Regulatory Compliance:
  Engage with suppliers possessing current, verified approvals to prevent legal and operational risks.

Conclusion

The supply landscape for Epivir (lamivudine) reflects a mature market with a dual structure of originator stewardship and widespread generic manufacturing. Major producers include GlaxoSmithKline, Indian pharmaceutical giants such as Cipla and Hetero, Chinese API manufacturers, and regional producers worldwide. Suppliers with WHO prequalification and regulatory approvals ensure broader access, especially for developing countries reliant on affordable anti-HIV and hepatitis B therapies.

Ensuring sustained supply requires strategic sourcing that emphasizes quality, regulatory compliance, and diversification. As patents expire and markets evolve, partnerships with reputable generic manufacturers remain vital to maintaining global access to this essential medicine.

---

Key Takeaways

• Diverse Supplier Base: The Epivir supply chain comprises original manufacturers like GSK and numerous generic producers in India, China, and other regions.
• Regulatory Standards: WHO prequalification and approvals from US FDA and EMA are critical for global procurement.
• Supply Risks: Political, regulatory, and manufacturing disruptions underline the need for supplier diversification.
• Market Dynamics: Patent expirations and licensing agreements have expanded the supplier landscape, increasing availability and reducing costs.
• Strategic Sourcing: Buyers should prioritize suppliers with proven quality standards and regulatory approvals to ensure continuous and compliant supply.

---

FAQs

1. Who are the primary manufacturers of generic lamivudine (Epivir)?
Indian companies such as Cipla, Hetero, Mylan (Viatris), and Lupin are leading generic producers. Several Chinese firms also supply APIs and finished formulations.

2. How does patent expiration impact Epivir's supply chain?
Patent expiry in 2005 facilitated the entry of numerous generic manufacturers, substantially increasing supply options, lowering costs, and expanding access, especially in low-income markets.

3. What role does WHO prequalification play in Epivir supply?
It acts as a benchmark of quality and safety, enabling procurement by UN agencies and governments, thereby improving access in resource-limited settings.

4. Are there regional differences in Epivir suppliers?
Yes; while Indian and Chinese producers dominate global API supply, regional manufacturers in Latin America and Africa fulfill local needs, often under licensing agreements.

5. What are the main risks in the Epivir supply chain?
Risks include manufacturing disruptions, raw material shortages, regulatory delays, and geopolitical factors affecting trade and approvals.

---

Sources:

[1] GlaxoSmithKline. "Epivir (lamivudine) API and formulations." GSK Corporate Reports, 2022.
[2] WHO Prequalification Program. "Prequalification of Antiretroviral Medicines," 2022.
[3] Indian Pharmaceutical Alliance. "Indian Generics in the Global Market," 2021.
[4] U.S. FDA Database. "Approved Drug Products," 2022.
[5] Global Fund Supply Chain Data. "Procurement of Antiretroviral Drugs," 2022.