Share This Page
Suppliers and packagers for combivir
✉ Email this page to a colleague
combivir
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COMBIVIR
Introduction
COMBIVIR, a combination antiretroviral medication, is widely prescribed in the management of HIV/AIDS. Approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA), this fixed-dose combination enhances patient adherence and simplifies therapy regimens. The drug comprises two active ingredients: lamivudine and zidovudine, which work synergistically to inhibit HIV replication.
Given the critical role COMBIVIR plays in HIV therapy, understanding its supply chain dynamics—including primary suppliers—remains essential for healthcare providers, pharmaceutical companies, and policymakers. This article explores the key suppliers involved in the manufacturing and distribution of COMBIVIR, dissecting their roles, sourcing strategies, and impact on drug availability.
Overview of COMBIVIR Manufacturing and Supply Chain
COMBIVIR’s manufacturing process involves sourcing active pharmaceutical ingredients (APIs), excipients, and packaging materials from a network of suppliers. The process adheres to strict quality standards stipulated by regulatory bodies, ensuring potency, purity, and safety.
Historically, the original formulation was produced by GlaxoSmithKline (GSK), now a part of Viiv Healthcare following brand restructuring and licensing agreements. GSK's manufacturing facilities in Europe and North America have historically been primary sources for COMBIVIR. However, as generic formulations entered the market, multiple manufacturers worldwide stepped into the supply chain.
Major Suppliers of COMBIVIR Active Pharmaceutical Ingredients (APIs)
1. GlaxoSmithKline (GSK)
GSK, the original innovator and patent holder, remains a key supplier of the APIs used in COMBIVIR, particularly in areas where the proprietary formulation is still supplied under patent or licensing agreements. GSK's manufacturing sites are GMP-certified and adhere to international standards, ensuring high-quality APIs.
2. Contract Manufacturing Organizations (CMOs)
With patent expirations and subsequent generic entry, GSK partners with various CMOs to produce APIs at scale. These organizations include:
- Virable and Hetero Labs (India): Known for producing high-quality antiretroviral APIs for multiple global markets.
- Cipla (India): Supplies generic lamivudine and zidovudine APIs to various manufacturers.
3. Chinese and Indian API Producers
The majority of generic APIs, especially for low- and middle-income markets, originate from Chinese and Indian API producers owing to their cost competitiveness and manufacturing capacity.
- Lupin (India): Supplies zidovudine and lamivudine APIs for generic formulations, including COMBIVIR equivalents.
- Aurobindo Pharma and Sun pharma (India): Major producers of antiretroviral APIs, with extensive export networks.
Manufacturers of COMBIVIR in Finished Dosage Forms
While original patented formulations have limited manufacturers, numerous generic producers globally manufacture fixed-dose combinations similar to COMBIVIR.
Key generic manufacturers include:
- Mylan (now part of Viatris): Produces generic COMBIVIR in multiple markets.
- Cipla (India): One of the largest producers, supplying alliances across Africa, Asia, and South America.
- Hetero Labs (India): Offers generic versions, compliant with WHO prequalification standards.
- Natco Pharma (India): Provides affordable antiretroviral fixed-dose combinations.
Distribution and Supply Chain Distribution Channels
COMBIVIR distribution varies greatly across geographies. In high-income countries, pharmaceutical distributors sell through hospital and retail pharmacies under strict regulation, with supply maintained by proprietary and licensed manufacturers.
In low- and middle-income countries (LMICs), procurement largely occurs via international agencies such as the Global Fund, Clinton Health Access Initiative (CHAI), and UNITAID, which source products from multiple manufacturers to ensure affordability and broad access.
Key distribution frameworks:
- Wholesale distribution networks: Ensuring timely delivery from manufacturers to healthcare facilities.
- Procurement agencies: Often rely on bulk purchasing through prequalified suppliers, emphasizing quality assurance.
- Generic manufacturing hubs: Especially in India and China, which serve as primary suppliers to LMICs.
Regulatory and Quality Assurance of Suppliers
Suppliers of COMBIVIR and its components must comply with international standards such as WHO Good Manufacturing Practices (GMP), FDA regulations, and EMA requirements. Regulatory agencies routinely conduct inspections and quality assessments, central to maintaining drug safety and efficacy.
Notably, WHO prequalification programs evaluate API producers and finished product manufacturers, ensuring conformity with global standards. Many Indian and Chinese API manufacturers have obtained WHO prequalification, facilitating their participation in global HIV treatment programs.
Market Dynamics and Supply Security
The supply landscape for COMBIVIR is shaped by patent protections, licensing agreements, and the entry of generics. Patent expiration has catalyzed a proliferation of manufacturers, increasing supply options but also raising concerns over quality variances. The COVID-19 pandemic posed challenges to supply chains, accentuating the importance of diversified sourcing strategies and stockpiling.
Efforts by governments and NGOs aim to diversify suppliers to mitigate risks—particularly in regions heavily reliant on a handful of manufacturers. International procurement programs favor companies with WHO prequalification status, ensuring safety and continuous supply.
Future Outlook
As HIV treatment paradigms evolve, so will the pharmaceutical supply network. The transition towards integrase inhibitors and newer combination therapies might shift demand away from traditional COMBIVIR formulations. Nonetheless, existing suppliers, especially in LMICs, continue to play a vital role in maintaining access.
Innovation in manufacturing, strategic partnerships, and adherence to quality standards will remain central to securing a stable supply chain. Regulatory harmonization and transparency are crucial to fostering a resilient supply ecosystem.
Key Takeaways
- The primary suppliers of COMBIVIR include original manufacturer GSK and numerous generic API producers predominantly in India and China.
- Contract manufacturing organizations (CMOs) are integral in scaling API production and ensuring global availability.
- Generic manufacturers such as Mylan, Cipla, and Hetero dominate the finished drug market, especially in LMICs.
- Regulatory compliance and WHO prequalification efforts underpin supply security and quality assurance.
- Diversification in suppliers and production sources is essential to mitigate geopolitical and logistical risks, ensuring continued access to COMBIVIR worldwide.
FAQs
1. Who are the main suppliers of the APIs used in COMBIVIR?
Major API producers include GlaxoSmithKline, Cipla, Lupin, Aurobindo Pharma, and Hetero Labs, primarily based in India and China.
2. Is GSK still involved in manufacturing COMBIVIR?
GSK continues to supply APIs for certain formulations under licensing, but numerous generics are produced by third-party manufacturers.
3. How do procurement agencies ensure the quality of COMBIVIR supply?
Through strict adherence to WHO prequalification standards, GMP compliance, and ongoing regulatory inspections.
4. What role do Indian pharmaceutical companies play in COMBIVIR supply?
They are key suppliers of APIs and finished formulations, especially for global markets in LMICs, offering cost-effective and reliable options.
5. How might future developments influence COMBIVIR supply chains?
The shift towards newer antiretroviral therapies may reduce demand, but existing supply chains will remain vital in certain regions. Regulatory reforms and manufacturing innovations will shape future supply security.
Sources:
[1] WHO Prequalification of medicines program.
[2] U.S. FDA drug approvals.
[3] GSK Annual Reports.
[4] Indian pharmaceutical industry data.
[5] Global Fund procurement reports.
More… ↓
