Suppliers and packagers for retrovir

retrovir

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	RETROVIR	zidovudine	CAPSULE;ORAL	019655	NDA	ViiV Healthcare Company	49702-211-20	100 CAPSULE in 1 BOTTLE (49702-211-20)	2010-10-28
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951	NDA	ViiV Healthcare Company	49702-213-26	5 VIAL, SINGLE-USE in 1 CARTON (49702-213-26) / 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)	2010-11-04
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910	NDA	ViiV Healthcare Company	49702-212-48	240 mL in 1 BOTTLE (49702-212-48)	2010-10-28

Suppliers for the Pharmaceutical Drug: Retrovir

Last updated: July 29, 2025

Introduction

Retrovir, a well-known antiretroviral drug primarily used to treat HIV/AIDS, has played a pivotal role in managing the global HIV epidemic since its introduction. Market dynamics for Retrovir (zidovudine or AZT) are shaped by a complex interplay of patent statuses, manufacturing capabilities, regulatory standards, and regional market forces. This report provides an in-depth analysis of suppliers for Retrovir, outlining the key players, manufacturing landscapes, supply chain considerations, and emerging trends driving the availability of this critical medication.

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Overview of Retrovir (Zidovudine/AZT)

Retrovir, branded as AZT, was the first antiretroviral medication approved for HIV treatment in 1987. Its mechanism involves inhibiting reverse transcriptase, an enzyme essential for HIV replication. The drug's significance persisted through decades of evolving HIV treatment regimens, although now it often features as part of combination therapies.

Manufacturing of Retrovir involves complex chemical synthesis and stringent quality controls consistent with global regulations. As patent protections have expired in numerous regions, the landscape of suppliers has expanded, fostering increased competition and supply diversification.

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Global Suppliers of Retrovir (Zidovudine)

1. Original Patent Holders and Early Manufacturers

• GlaxoSmithKline (GSK): As the original developer of AZT, GSK was among the earliest suppliers globally. During patent protection (filed in the 1980s), GSK controlled manufacturing and distribution rights, primarily serving North America, Europe, and select markets.

• F. Hoffmann-La Roche: Collaborated in early HIV/AIDS management and contributed to manufacturing, particularly in the European market.

2. Generics Manufacturers Post-Patent Expiry

Following patent expiration in many jurisdictions (e.g., 2005 in the US, 2010 in the EU), numerous generic pharmaceutical companies began manufacturing AZT:

• Hikma Pharmaceuticals: A leading generic producer, Hikma manufactures AZT across several markets, adhering to Good Manufacturing Practices (GMP) and WHO prequalification standards.

• Cipla: An Indian pharmaceutical giant, Cipla is renowned for producing affordable antiretroviral medications, including AZT, tailored for low- and middle-income countries.

• Aurobindo Pharma: Another India-based manufacturer, Aurobindo offers cost-effective AZT formulations, emphasizing supply security for regions with high HIV burdens.

• Drugmakers in China: Several domestic manufacturers, often supplying emerging markets, produce AZT under WHO-prequalified standards.

3. Regional and Local Suppliers

In addition to global players, regional producers, particularly in Africa and Southeast Asia, supply AZT formulations to meet local demands, including:

• Egyptian National Pharmacuticals: Supplies AZT to North Africa.

• South African Manufacturers: Numerous local companies produce generic AZT formulations under licensing agreements or WHO prequalification schemes.

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Supply Chain Dynamics and Key Considerations

1. Manufacturing Capacity and Quality Assurance

Supply reliability hinges on manufacturing capacity, quality standards, and adherence to Good Manufacturing Practices (GMP). WHO prequalification accreditation is essential for procurement by global health agencies, ensuring compliance with international standards.

2. Regulatory Environment and Patent Landscape

Patent expirations have catalyzed increased generic production. However, some branded formulations remain under patent protection or supplemental patents in certain regions, affecting supply options.

3. Price Competition and Market Access

Cost-effectiveness drives procurement, especially for national HIV programs. Generics from Indian and Chinese producers dominate supply channels due to competitive pricing and compliance with international standards.

4. Supply Chain Risks

Disruptions may arise from manufacturing issues, geopolitical tensions, or regulatory delays. Pandemic-related challenges, such as those experienced during COVID-19, further complicated supply chains but have also prompted diversification.

5. Emerging Trends

• Increased emphasis on quality assurance and WHO prequalification to meet international donor requirements.

• Expansion of local manufacturing capabilities in Africa to improve self-reliance.

• Development of fixed-dose combination therapies incorporating AZT to streamline treatment.

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Major Suppliers' Role in Global HIV Treatment Initiatives

Global health agencies, notably the Global Fund and PEPFAR, rely heavily on certified generic suppliers for HIV medications, including AZT. Their procurement strategies favor manufacturers with proven quality, affordability, and supply stability.

1. WHO Prequalification and Regulatory Compliance

Suppliers with WHO prequalification status are prioritized for international procurement, ensuring drug quality and fostering supply confidence.

2. Impact of Patent Laws and TRIPS Agreements

Intellectual property laws influence patent status, directly impacting supplier competition and market entry in various regions.

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Future Outlook and Market Trends

• The continued expiration of patents will sustain growth in generic AZT supply.

• Investment in manufacturing infrastructure in Africa aims to improve drug security.

• Potential development of novel formulations and combination therapies could impact the demand for standalone AZT.

• Global HIV treatment guidelines increasingly favor integrase inhibitor-based regimens, potentially reducing reliance on AZT, but demand remains steady due to established safety, efficacy, and cost advantages.

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Key Takeaways

• The supplier landscape for Retrovir (AZT) has transitioned from a handful of patent-holding corporations to a broad array of generic manufacturers, notably in India and China.

• WHO prequalification and regulatory compliance are critical determinants of supplier credibility and market access.

• Supply stability depends on manufacturing capacity, quality assurance, and geopolitical considerations.

• The robust demand in low- and middle-income countries sustains a dynamic, competitive supply environment.

• Evolving HIV treatment guidelines may influence future demand, but current supplies are well-supported by diverse global manufacturers.

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FAQs

1. Who are the primary global manufacturers of AZT today?
Major suppliers include Hikma Pharmaceuticals, Cipla, Aurobindo Pharma, and numerous Chinese and African manufacturers, all producing WHO prequalified AZT formulations to supply global markets, especially in low- and middle-income countries.

2. How does patent expiration influence AZT supply?
Patent expirations have facilitated the entry of generic manufacturers, increasing supply availability, reducing costs, and expanding access worldwide.

3. What role does WHO prequalification play in AZT procurement?
WHO prequalification ensures that AZT meets international quality standards, enabling procurement by global health organizations and reducing supply risks.

4. Are there regional differences in AZT supply sources?
Yes. While India and China dominate global generics production, regional manufacturers in Africa and Southeast Asia also supply local markets to enhance drug access and security.

5. How might future HIV treatment guidelines impact AZT demand?
Recent guidelines favor integrase inhibitors and other drugs, potentially decreasing AZT's use in developed markets. However, demand remains substantial in resource-limited settings due to cost benefits and established supply chains.

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References

[1] World Health Organization. Prequalification of medicines. Retrieved from WHO official site.
[2] Global Fund. HIV/AIDS Treatment Programmes. https://www.theglobalfund.org/en/.
[3] IMS Health. Antiretroviral Market Analysis. 2022.
[4] Cipla Ltd. Product Portfolio. https://www.cipla.com/.
[5] Aurobindo Pharma Ltd. Corporate Overview. https://www.auropath.com/.