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Suppliers and packagers for generic pharmaceutical drug: ABACAVIR SULFATE
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ABACAVIR SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | ABACAVIR SULFATE | abacavir sulfate | SOLUTION;ORAL | 077950 | ANDA | Rising Pharma Holdings, Inc. | 64980-405-24 | 1 BOTTLE in 1 CARTON (64980-405-24) / 240 mL in 1 BOTTLE | 2018-03-14 |
| Aurobindo Pharma Ltd | ABACAVIR SULFATE | abacavir sulfate | SOLUTION;ORAL | 077950 | ANDA | Aurobindo Pharma Limited | 65862-089-24 | 1 BOTTLE in 1 CARTON (65862-089-24) / 240 mL in 1 BOTTLE | 2018-03-14 |
| Hetero Labs Ltd Iii | ABACAVIR SULFATE | abacavir sulfate | SOLUTION;ORAL | 201107 | ANDA | Camber Pharmaceuticals, Inc. | 31722-562-24 | 240 mL in 1 BOTTLE (31722-562-24) | 2016-09-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Abacavir Sulfate
Introduction
Abacavir sulfate is a crucial antiretroviral medication used predominantly in the treatment of HIV/AIDS. Classified as a nucleoside reverse transcriptase inhibitor (NRTI), abacavir effectively inhibits the replication of HIV-1 by binding to the viral reverse transcriptase enzyme. The medication is marketed under various brand names, with major pharmaceutical companies supplying it globally. This article examines the key suppliers of abacavir sulfate, highlighting their manufacturing capacities, global reach, and strategic importance within the pharmaceutical supply chain. For stakeholders in healthcare procurement, understanding the supplier landscape is vital for ensuring drug availability, quality, and cost-efficiency.
Global Manufacturing Landscape for Abacavir Sulfate
1. Johnson & Johnson (Janssen Pharmaceuticals)
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is among the leading producers of abacavir sulfate. The company's extensive manufacturing facilities in the United States, Europe, and Asia enable large-scale production aligned with stringent regulatory standards. Janssen’s abacavir formulations are widely used globally under the brand name Ziagen. The company maintains high standards of Good Manufacturing Practice (GMP), ensuring drug consistency and safety. Their strategic distribution network allows ease of access across North America, Europe, Asia, and emerging markets.
2. ViiV Healthcare
ViiV Healthcare, a specialized HIV/AIDS pharmaceutical company majority-owned by GlaxoSmithKline (GSK), is a key supplier of abacavir sulfate, particularly through its branded combination drugs such as Epzicom (abacavir and lamivudine). ViiV’s manufacturing sites in the UK and other regions harness advanced technology capable of producing high-quality antiretrovirals at scale. The company's focus on innovation and committed supply chain management positions it as a significant contributor to the global HIV treatment landscape.
3. Cipla Limited
Cipla, an Indian pharmaceutical giant, is a major producer of generic antiretroviral drugs, including abacavir sulfate. The company's facilities in India adhere to international quality standards such as WHO-GMP and have been certified by regulatory bodies like the US FDA and EMA. Cipla’s competitive pricing and widespread distribution network make it a vital supplier especially to low- and middle-income countries (LMICs). The company plays a pivotal role in ensuring global access to affordable HIV medications.
4. Mylan (Now part of Viatris)
Mylan, rebranded as Viatris following a merger with Pfizer’s off-patent drugs division, supplies abacavir sulfate as part of extensive generic portfolios. Their manufacturing units in India, the Philippines, and elsewhere produce formulations that serve both developed and developing markets. Viatris emphasizes quality control, regulatory compliance, and supply chain resilience, positioning it as a significant player for healthcare providers seeking cost-effective HIV therapies.
5. Hetero Drugs Limited
Hetero, based in India, is recognized for producing a wide array of antiretroviral medications, including abacavir sulfate. Their manufacturing plants comply with international standards, and they hold approvals from agencies such as the US FDA, EU EMA, and WHO. Hetero's extensive export network facilitates global distribution, especially critical for ensuring drug access in resource-limited settings.
Key Attributes of Leading Suppliers
Regulatory Compliance and Certification
Top suppliers maintain compliance with international quality standards, including GMP, US FDA, EMA, and WHO prequalification. These certifications assure product quality and safety, essential for antiretroviral drugs like abacavir sulfate.
Manufacturing Capacity and Scalability
Leading producers invest heavily in scalable manufacturing infrastructure to meet global demand fluctuations. Their capacity planning involves risk mitigation strategies for supply disruptions, critical for chronic therapies such as HIV.
Pricing and Market Access
Suppliers such as Cipla and Hetero offer cost-competitive formulations, critical for LMICs. Patent expiration and generic manufacturing have driven down costs, expanding access to abacavir sulfate worldwide.
Supply Chain Resilience
Diversified sourcing and regional manufacturing hubs enhance supply chain resilience. Companies are adopting digital tracking and cold chain logistics to ensure drug integrity and uninterrupted supply.
Regulatory and Patent Considerations
Abacavir sulfate’s patent expiration in multiple jurisdictions has facilitated the entry of multiple generic suppliers into the market. Regulatory agencies such as the US FDA and EMA have implemented prequalification procedures, ensuring only qualified manufacturers can supply the drug to international markets. Patent landscapes continue to evolve, with patent challenges and settlements influencing the supply dynamics, especially in emerging economies.
Emerging Trends and Future Outlook
- Biosimilars and Fixed-Dose Combinations: Efforts are underway to develop fixed-dose combinations containing abacavir sulfate to improve patient adherence.
- Manufacturing Technology Advancements: Continuous innovation, such as continuous manufacturing processes, enhances scalability and reduces costs.
- Global Procurement Strategies: International agencies are fostering pooled procurement mechanisms to leverage economies of scale among suppliers, ensuring consistent access.
Conclusion
The landscape of abacavir sulfate suppliers is characterized by a mix of multinational pharmaceutical companies and regional generic manufacturers. Johnson & Johnson, ViiV Healthcare, Cipla, Viatris, and Hetero are key players ensuring global availability. Their combined efforts under regulatory compliance and supply resilience are vital to meet the ongoing demand for HIV treatment worldwide. Strategic procurement, quality assurance, and market intelligence remain essential for healthcare providers and policymakers to optimize drug access and affordability.
Key Takeaways
- Leading suppliers such as Johnson & Johnson, ViiV Healthcare, Cipla, Viatris, and Hetero ensure a diverse and resilient supply chain for abacavir sulfate.
- Generic manufacturers dominate lower-cost markets, expanding access in LMICs, while branded companies focus on high-grade formulations.
- Regulatory compliance and international certifications are critical in maintaining quality and trust in the supply chain.
- Patent expirations have enabled increased competition, driving down prices and improving access.
- Innovations in manufacturing and procurement strategies will shape the future landscape for abacavir sulfate supply.
Frequently Asked Questions (FAQs)
1. Which companies are the primary suppliers of abacavir sulfate globally?
Major suppliers include Johnson & Johnson (Janssen), ViiV Healthcare, Cipla, Viatris (formerly Mylan), and Hetero Drugs, each serving different markets with varying formulations and pricing.
2. How do patent laws affect the supply of abacavir sulfate?
Patent expiration in multiple jurisdictions has facilitated the entry of generic manufacturers, increasing supply options and reducing costs, especially in LMICs.
3. Are all suppliers of abacavir sulfate compliant with international quality standards?
Reputable suppliers adhere to GMP standards and obtain certifications from agencies such as the US FDA, EMA, and WHO prequalification, ensuring consistent quality.
4. What role do generic manufacturers play in the abacavir sulfate supply chain?
Generic producers are pivotal in providing affordable abacavir sulfate to resource-constrained markets, expanding access to HIV treatment.
5. What trends are shaping the future supply of abacavir sulfate?
Innovations in manufacturing technology, development of fixed-dose combinations, and procurement strategies aimed at enhancing supply chain resilience are shaping the future landscape.
Sources
[1] Johnson & Johnson, Janssen Pharmaceuticals. "Ziagen." Official Website.
[2] ViiV Healthcare. "ViiV Portfolio." Corporate Reports.
[3] Cipla Limited. "Global Operations and Certifications." Corporate Website.
[4] Viatris. "Product Portfolio." Official Communications.
[5] Hetero Drugs Limited. "Quality Standards and Certifications." Company Profile.
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