Suppliers and packagers for epzicom

epzicom

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	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652	NDA	ViiV Healthcare Company	49702-206-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-206-13)	2010-10-12

Suppliers for the Pharmaceutical Drug: EPZICOM

Last updated: July 29, 2025

Introduction

EPZICOM is a combination antiretroviral medication primarily used in the treatment of HIV-1 infection. The formulation combines abacavir sulfate and lamivudine, two nucleoside reverse transcriptase inhibitors (NRTIs), and is marketed by Gilead Sciences. As a critical component in HIV therapy, the supply chain for EPZICOM is tightly regulated by patent protections, manufacturing standards, and distribution agreements. Understanding the suppliers involved in the production and distribution of EPZICOM offers insights into inventory stability, market competition, and regulatory compliance.

Manufacturers and Original Suppliers

Gilead Sciences is the original patent holder and primary supplier of EPZICOM. The company oversees the formulation, production, and global distribution of the drug. The manufacturing process involves sourcing high-quality active pharmaceutical ingredients (APIs) for abacavir and lamivudine from specialized chemical suppliers before formulation into the final dosage forms.

API Suppliers

The APIs for abacavir and lamivudine are produced by a limited number of specialized chemical manufacturing companies, given the stringent quality standards necessary for antiretroviral drugs. Leading API suppliers include:

• Viva Biotech: A Chinese biopharmaceutical company that supplies APIs for various antiviral drugs, including nucleoside analogs.
• Hubei Biocause Pharmaceutical Co., Ltd.: A prominent Chinese API producer with capabilities in synthesizing nucleoside analogs.
• Sun Pharmaceutical Industries Ltd.: An Indian company providing APIs and intermediates for HIV medications.
• Cipla Ltd.: An Indian pharmaceutical company actively involved in the production of antiretroviral APIs and finished formulations.

The sourcing of APIs from these suppliers involves rigorous quality assurance to meet international standards such as the U.S. Pharmacopeia (USP) and European Pharmacopoeia (Ph.Eur.), ensuring safety and efficacy.

Formulation and Packaging

The finished pharmaceutical formulations are produced in Gilead’s manufacturing facilities, which comply with Good Manufacturing Practice (GMP) standards. Though Gilead primarily handles final formulation and packaging, some regional manufacturing partnerships exist to meet local demand, often involving licensed generic manufacturers under Gilead’s licensing agreements.

Generic Manufacturers and Suppliers

Following patent expiration or licensing agreements, generic manufacturers have entered various markets, increasing supply diversity. These include:

• Cipla: As a licensee in certain territories, Cipla produces generic versions of abacavir and lamivudine, often under local manufacturing agreements.
• Hetero Drugs Ltd.: An Indian pharmaceutical firm offering generic antiretrovirals, including EPZICOM equivalents in certain markets.
• Mylan (now part of Viatris): A notable supplier of generic antiretrovirals globally, including combination formulations similar to EPZICOM.
• Aurobindo Pharma: A major Indian manufacturer capable of producing APIs and finished formulations for HIV drugs.

Distribution Channels

The distribution network for EPZICOM spans wholesalers, government procurement agencies, and hospitals worldwide. Major distributors include:

• McKesson Corporation: A leading distributor for pharmaceuticals across North America, supplying hospitals and clinics with the original or generic formulations.
• VWR International: International distributor providing APIs and finished drugs in various markets, often sourcing from regional manufacturers.
• Gilead’s Authorized Distributors: Gilead enforces strict control over distribution channels to prevent counterfeit and ensure supply integrity.

Supply Chain Challenges

The supply chain for EPZICOM faces several challenges:

• Regulatory Variability: Different countries impose distinct regulatory requirements, affecting raw material sourcing and manufacturing acceptability.
• Patent and Licensing Restrictions: Patent protections in certain jurisdictions limit generic entry, influencing supplier diversity and pricing.
• API Supply Risks: Concentration of API manufacturing points can lead to supply disruptions, especially if geopolitical or manufacturing issues arise.
• Quality Assurance: Maintaining high standards across diverse suppliers requires constant oversight and compliance monitoring.

Market Influences Affecting Suppliers

The evolution of the HIV treatment landscape impacts EPZICOM's supply chain:

• Patent Expirations: As patents expire in multiple markets, generic manufacturers enter, increasing supply options but also market competition.
• Innovative Therapies: The development of integrase inhibitors and fixed-dose combinations modifies demand patterns, influencing procurement priorities for suppliers.
• Global Access Initiatives: Programs like the Clinton Health Access Initiative (CHAI) promote affordable medication access, impacting supplier roles and pricing strategies.

Conclusion

The supply ecosystem supporting EPZICOM features a complex interplay between original patent-holders, specialized API producers, regional generic manufacturers, and robust distribution networks. Ensuring a stable, high-quality supply chain requires continuous vigilance over regulatory landscapes, manufacturing quality, and geopolitical factors. Companies seeking to enter or expand within this space must prioritize strategic sourcing, compliance, and quality assurance to mitigate risks and capitalize on market opportunities.

Key Takeaways

• Strategic API Sourcing: Reliable suppliers for abacavir and lamivudine are critical; key players are primarily based in China and India with stringent quality controls.
• Regulatory Compliance: Suppliers must adhere to international standards such as GMP, USP, and EMA requirements to ensure drug safety and market access.
• Patent Dynamics: Patent expirations facilitate market entry for generics, increasing supplier diversity but also intensifying competition.
• Manufacturing and Distribution Control: Original manufacturers maintain tight control over their supply chains; licensing agreements enable regional generic production.
• Market Trends: Advances in HIV therapy and global access initiatives shape supplier roles, influencing pricing and availability.

FAQs

1. Who are the main API suppliers for EPZICOM?
   Chinese companies like Viva Biotech and Hubei Biocause Pharmaceutical, along with Indian firms such as Sun Pharma and Cipla, are primary API suppliers for abacavir and lamivudine used in EPZICOM.

2. Can generic manufacturers supply EPZICOM?
   Yes, following patent expirations or licensing agreements, generic manufacturers like Cipla, Hetero, and Aurobindo can produce and supply bioequivalent formulations in approved markets.

3. How does regulatory oversight influence suppliers?
   Strict adherence to GMP, USP, and EMA standards is mandatory, ensuring API and finished product quality. Regulatory compliance gatekeeps market access for suppliers globally.

4. What are the risks associated with the EPZICOM supply chain?
   Supply disruptions may stem from API manufacturing concentration, regulatory delays, patent protections limiting generic competition, or geopolitical issues affecting regional manufacturing.

5. How do global health initiatives impact EPZICOM suppliers?
   Programs promoting affordability and access, such as Gilead’s licensing agreements and global health policies, influence supplier participation, pricing strategies, and distribution channels.

References

1. Gilead Sciences, EPZICOM product information. Gilead.com.
2. U.S. Food & Drug Administration (FDA), Approved Drug Products, API and formulation standards.
3. Market research reports on global antiretroviral drug manufacturing.
4. World Health Organization (WHO), Guidelines on HIV treatment and procurement.
5. Industry reports on pharmaceutical supply chain dynamics and API manufacturing hubs.