Suppliers and packagers for generic pharmaceutical drug: NEVIRAPINE

NEVIRAPINE

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	NEVIRAPINE	nevirapine	SUSPENSION;ORAL	077702	ANDA	Aurobindo Pharma Limited	65862-057-11	100 mL in 1 BOTTLE (65862-057-11)	2012-05-22
Aurobindo	NEVIRAPINE	nevirapine	SUSPENSION;ORAL	077702	ANDA	Aurobindo Pharma Limited	65862-057-24	240 mL in 1 BOTTLE (65862-057-24)	2012-05-22
Macleods Pharms Ltd	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	206879	ANDA	Macleods Pharmaceuticals Limited	33342-238-07	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)	2017-10-07
Mylan	NEVIRAPINE	nevirapine	TABLET, EXTENDED RELEASE;ORAL	205651	ANDA	Mylan Pharmaceuticals Inc.	0378-4890-93	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)	2014-10-29

Suppliers for the Pharmaceutical Drug: NEVIRAPINE

Last updated: July 28, 2025

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Introduction

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) primarily used in the treatment of HIV-1 infections. Since its approval, the drug has played a critical role in antiretroviral therapy, especially within combination regimens. Its global reliance underscores the importance of a robust supply chain, drawing attention to key manufacturers and suppliers who ensure consistent availability. This report explores the leading suppliers of nevirapine, their manufacturing capabilities, regulatory status, and implications for stakeholders.

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Global Supply Landscape of Nevirapine

The global market for nevirapine predominantly involves generic manufacturers and a limited number of originator pharmaceutical companies. The supply chain is characterized by a mix of pharmaceutical giants, regional manufacturers, and Contract Manufacturing Organizations (CMOs). As patents for nevirapine expired around 2000, generics have proliferated, primarily in developing countries with high HIV prevalence.

Major Suppliers and Manufacturers

1. Hetero Drugs Limited (India)
   As a leading producer of antiretrovirals, Hetero supplies nevirapine in multiple formulations, including tablets and dispersible forms. The company's robust manufacturing facilities in India adhere to regulatory standards such as WHO-GMP and stringent USFDA and EMA guidelines. Hetero supplies to numerous African and Asian markets, often through licensing agreements with global organizations.

2. Mylan (now part of Viatris)
   Mylan’s global footprint includes manufacturing facilities in India, the Philippines, and other regions. It offers generic nevirapine tablets, with extensive distribution networks in low- and middle-income countries. Mylan’s compliance with international standards ensures product quality and regulatory acceptance (e.g., WHO prequalification).

3. Cipla Limited (India)
   Cipla is a prominent supplier of antiretrovirals, including nevirapine. The company’s manufacturing complexes in India operate under WHO-GMP and have secured prequalification status from WHO and approvals from numerous national agencies. Cipla’s strategic focus on affordable HIV medications has made it a key player in global HIV treatment initiatives.

4. Gilead Sciences (United States)
   As the originator of first-generation antiretrovirals, Gilead historically supplied nevirapine but has since shifted focus toward newer therapies. However, Gilead’s legacy manufacturing operations still serve as a baseline for clinical supply and legacy stock, with some residual supply maintained through licensing agreements and partnerships.

5. Relebio Biosciences (China)
   Emerging Chinese pharmaceutical firms such as Relebio Biosciences have entered the market, often supplying nevirapine with competitive pricing. Their manufacturing facilities are increasingly compliant with international standards, although regulatory acceptance varies by country.

Regional and Local Suppliers

In addition to multinational corporations, numerous regional manufacturers produce generic nevirapine formulations to meet local demand, especially in Africa, Southeast Asia, and Latin America. These suppliers often operate under WHO prequalification or national regulatory approvals, ensuring product adherence to safety and efficacy standards.

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Regulatory and Quality Considerations

Suppliers of nevirapine must navigate diverse regulatory landscapes. WHO prequalification plays a significant role in ensuring suppliers meet global quality benchmarks, facilitating procurement by international agencies like UNICEF and UNAIDS. The USFDA, EMA, and local agencies also set manufacturing and quality standards that suppliers must satisfy to access certain markets.

Supply Chain Challenges and Risks

• Patent Expiry and Market Entry: Following patent expiration, a surge of generic manufacturers emerged, benefiting supply diversity but also raising concerns about quality consistency.
• Regulatory Discrepancies: Variability in approvals and quality standards can lead to supply disruptions or patient safety issues.
• Manufacturing Capacity Constraints: Limited manufacturing capacity or geopolitical issues may cause shortages, impacting HIV treatment continuity.
• Price Competition: Intense price competition among generic suppliers influences market dynamics and procurement strategies of governments and NGOs.

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Market Trends and Future Outlook

The ongoing diversification of suppliers and increased regulatory oversight improve supply resilience. However, strategic stockpiling and diversified sourcing remain critical to preventing shortages. Innovations in formulation, such as dispersible tablets adapted for pediatric use, are expanding supplier product portfolios and market opportunities. Additionally, collaborations between originators and generic manufacturers—like licensing agreements—continue to stabilize supply.

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Conclusion

The supplier landscape for nevirapine is characterized by a mix of established multinational companies and regional generic producers. Key players like Hetero, Cipla, and Viatris dominate the market, leveraging WHO prequalification and adherence to international standards. Ensuring transparent, compliant, and diversified sourcing pathways is essential for global HIV treatment programs, particularly in resource-limited settings.

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Key Takeaways

• Market Participants: The primary suppliers are Indian generics companies—Hetero, Cipla, and Viatris—providing affordable, WHO-prequalified nevirapine formulations globally.
• Regulatory Compliance: Suppliers meeting WHO prequalification and national regulatory approvals are critical for seamless procurement, especially for international health agencies.
• Supply Stability: Diversified sourcing strategies and capacity building are vital to mitigate shortages and supply chain disruptions.
• Innovation and Formulation Development: Enhancing formulations for pediatric and fixed-dose applications expands supplier scope and market relevance.
• Future Outlook: Ongoing market competition, regulatory harmonization, and technological advances are expected to improve supply resilience and affordability.

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FAQs

1. Who are the leading global suppliers of nevirapine?
Indian pharmaceutical companies such as Hetero, Cipla, and Viatris (formerly Mylan) dominate global supply, supported by regional manufacturers in Africa, Asia, and Latin America.

2. What role does WHO prequalification play in nevirapine supply?
WHO prequalification ensures suppliers meet international quality standards, facilitating procurement by global agencies and expanding access in low-resource settings.

3. Are there any concerns regarding the quality of generic nevirapine?
Quality concerns are mitigated when suppliers adhere to WHO-GMP, EMA, or FDA standards. Prequalified generics are deemed to meet safety and efficacy benchmarks.

4. How do patent expirations influence nevirapine supply?
Patent expirations have increased generic competition, improving affordability and supply diversity but also necessitate robust regulatory oversight to maintain quality.

5. What future trends could impact nevirapine suppliers?
Technological advances in formulation, expanded regional manufacturing capacity, and increased regulatory harmonization are expected to enhance supply stability and product innovation.

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References

1. World Health Organization. (2021). Prequalification of medicines. Available at: WHO PQ
2. European Medicines Agency. (2022). Regulatory approval processes for antiretrovirals.
3. U.S. Food & Drug Administration. (2022). Approved HIV medications.
4. IMS Health. (2021). Global Antiretroviral Market Report.
5. Global HIV & AIDS statistics — UNAIDS. (2022). HIV drug access and market analysis.