Suppliers and packagers for generic pharmaceutical drug: doravirine; lamivudine; tenofovir disoproxil fumarate

doravirine; lamivudine; tenofovir disoproxil fumarate

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807	NDA	Merck Sharp & Dohme LLC	0006-5007-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)	2018-07-20

Suppliers for the Pharmaceutical Drug: DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Last updated: July 29, 2025

Overview

The combination of Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate forms a potent antiretroviral therapy (ART) used primarily in the management of HIV-1 infection. This fixed-dose combination offers improved adherence, reduced pill burden, and enhanced efficacy for patients. Given its significance in HIV treatment, identifying reliable suppliers is paramount for pharmaceutical companies, healthcare providers, and procurement agencies. This article provides an in-depth analysis of current suppliers, manufacturing sources, and the global supply chain landscape for these active pharmaceutical ingredients (APIs) and finished dosage forms.

Current Market Landscape

The global market for antiretroviral drugs, especially combination therapies like Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, is expanding steadily. The increasing prevalence of HIV/AIDS, especially in low- and middle-income countries, drives the demand for high-quality APIs and finished formulations. Leading pharmaceutical companies and API manufacturers supply these components through a complex network rooted in patented formulations and generic manufacturing.

Manufacturers and Suppliers of the Individual Components

1. Doravirine

   • Origin and Approval: Doravirine, marketed as Pifeltro® by Merck & Co., received FDA approval in 2018. It is a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), with a specific focus on resistance profiles.

   • Key Suppliers:

     • Merck & Co.: The original innovator, responsible for API production and commercialization.
     • China-based Manufacturers: Several Chinese API producers have licensed Doravirine synthesis processes, offering bulk APIs following rigorous bioequivalence and quality standards. Companies like Zhejiang Hisun Pharmaceuticals and Shanghai Fosun Pharmaceutical are notable.
     • India-based API Manufacturers: Some Indian pharmaceutical firms have established manufacturing capabilities for Doravirine APIs under licensing agreements, with suppliers such as Cadila Healthcare and Dr. Reddy’s Laboratories exploring or producing generics.

2. Lamivudine

   • Market Presence: Lamivudine (3TC) is one of the earliest antiretrovirals, with an extensive manufacturing history dating back to the 1990s.

   • Leading Suppliers:

     • India: Companies like Cipla, Hetero Drugs, and Aurobindo Pharma dominate global API production, given India’s large generics industry.
     • China: Manufacturers such as Zhejiang Huahai Pharmaceutical produce Lamivudine APIs for both domestic usage and export.
     • Global Manufacturers: Natco Pharma and Mylan also supply high-quality APIs.

3. Tenofovir Disoproxil Fumarate (TDF)

   • Inception & Controller: Gilead Sciences originally developed and commercialized TDF, which remains a key component of several HIV therapies.

   • Major Suppliers:

     • Gilead & Keryx Pharmaceuticals: Primary proprietary supplier for brand-name formulations.
     • Chinese Manufacturers: Companies like Fosun Pharma and Shanghai Fosun Pharmaceutical produce TDF APIs, often under licensing agreements or through generic licensing.
     • Indian Manufacturers: Dr. Reddy’s Labs, Natco Pharma, and Hetero are established producers for global markets.

Global Supply Chain Dynamics

The supply chain for these APIs is characterized by tight regulatory controls, quality assurance protocols, and licensing agreements. Major pharmaceutical companies often rely on a network of licensed manufacturers in China and India to meet global demand. The World Health Organization (WHO) prequalifies several API producers, ensuring adherence to strict quality standards.

Emerging markets and generic manufacturers have increasingly invested in local API manufacturing, reducing dependencies on a few dominant players and enhancing supply security. However, trade tensions and regulatory barriers can impact API availability, underscoring the importance of diversified sourcing strategies.

Finished Dosage Form Suppliers

Manufacturers specializing in fixed-dose combination (FDC) therapies leverage APIs supplied by the aforementioned producers. Notably:

• MSD (Merck): Supplies branded formulations using their proprietary API manufacturing process.
• Mylan (now part of Viatris): Offers generic FDCs, sourcing APIs globally.
• Hetero, Cipla, Aurobindo: Known for producing affordable generic combinations for HIV management.

Regulatory and Quality Considerations

Suppliers must comply with international standards such as the FDA, EMA, and WHO prequalification programs. These standards ensure API purity, bioavailability, and safety in final formulations. The reliance on China and India as primary API suppliers emphasizes the need for stringent quality audits and certification.

Emerging Trends and Future Outlook

• Diversification: Companies are diversifying suppliers to mitigate geopolitical and supply chain risks.
• Vertical Integration: Larger pharmaceutical firms seek in-house API production or exclusive licensing agreements.
• Biotech Innovation: Advances may lead to novel formulations with improved pharmacokinetics, impacting supplier dynamics.
• Regulatory Harmonization: International agencies are working towards standardized quality benchmarks, streamlining procurement.

Key Takeaways

• The global supply of Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate relies heavily on Chinese and Indian API manufacturers, emphasizing the importance of supply chain resilience.
• Leading pharmaceutical companies, both originators and generics, source APIs from licensed producers meeting international quality standards.
• Diversification and strict regulatory compliance are critical to ensure uninterrupted, high-quality supply.
• Future supply chain stability will depend on ongoing investments in manufacturing capacity, quality certification, and regulatory harmonization.

FAQs

1. Who are the primary suppliers of Doravirine APIs globally?
   Merck & Co. manufactures the original APIs, while several Chinese and Indian pharmaceutical companies, including Zhejiang Hisun and Cadila Healthcare, produce licensed generics.

2. Are there generic equivalents for Lamivudine and Tenofovir Disoproxil Fumarate?
   Yes, numerous Indian and Chinese manufacturers produce high-quality generic APIs, which are incorporated into numerous fixed-dose combinations worldwide.

3. How does quality assurance impact API sourcing?
   Suppliers must meet stringent regulatory standards such as WHO prequalification and FDA approval to ensure safety, efficacy, and purity, crucial for HIV therapies.

4. What trends are influencing the supply of these antiretroviral APIs?
   Increasing diversification of suppliers, regional manufacturing expansion, and regulatory harmonization are key trends shaping supply security.

5. What are the risks associated with API supply concentration?
   Heavy reliance on a limited number of sources can lead to supply disruptions, emphasizing the need for supply chain diversification and strategic stockpiling.

References

[1] U.S. Food and Drug Administration (FDA). Approvals and regulatory updates on antiretroviral APIs.
[2] World Health Organization (WHO). Prequalified pharmaceutical APIs list.
[3] Market reports on global antiretroviral API manufacturing industry.
[4] Company disclosures from Merck, Gilead, Cipla, Hetero, and other key players.
[5] Industry analysis articles on supply chain resilience in HIV pharmaceuticals.