Bulk Pharmaceutical API Sources for PREZISTA

Bulk Pharmaceutical API Sources for PREZISTA

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-846-141
BioChemPartner		BCP0726000058
BioChemPartner		BCP9000587
AKos Consulting & Solutions		AKOS015966592
MedChemexpress MCE		HY-17040
AbaChemScene		CS-0749

Bulk Active Pharmaceutical Ingredient (API) Sources for: PREZISTA

Last updated: July 29, 2025

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Introduction

PREZISTA (darunavir) is an antiretroviral medication used as part of combination therapy for HIV-1 infection. Its efficacy depends heavily on the quality and reliability of the bulk Active Pharmaceutical Ingredient (API) sourced from various manufacturers. This article examines the global API landscape for darunavir, focusing on key suppliers, supply chain considerations, regulatory compliance, and industry dynamics to assist pharmaceutical companies and stakeholders in strategic sourcing decisions.

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Overview of Darunavir API

Darunavir, a protease inhibitor, was developed by Janssen Pharmaceuticals (a Johnson & Johnson company). It’s characterized by complex chemical synthesis processes that demand high purity standards. The API must conform to stringent quality controls set by regulatory agencies such as the FDA, EMA, and others.

The production of darunavir API involves multi-step syntheses, requiring advanced manufacturing technologies with rigorous validation to meet APIs' pharmacopeial and safety standards.

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Major Suppliers of Darunavir API

1. Janssen Pharmaceuticals (Johnson & Johnson)

As the originator, Janssen remains the primary supplier of darunavir API. The company’s manufacturing facilities are located in the United States, Belgium, and other regions, ensuring consistent supply chains for both branded and authorized generic versions. Janssen’s API plant is compliant with Good Manufacturing Practices (GMP), ensuring high-quality standards.

However, limited third-party access to the patented API might restrict off-patent or generic manufacturing, depending on patent status and licensing agreements. Janssen’s API is often used exclusively within their initial formulations, but license agreements have opened pathways for qualified generic producers.

2. Contract Manufacturing Organizations (CMOs)

With patent expirations and increasing demand for generic HIV medications, several CMOs globally have developed darunavir API production capabilities:

• Hetero Labs (India): One of the prominent generic API producers, Hetero has invested in advanced synthesis processes, ensuring the API meets international quality standards.
• Cadila Healthcare (India): Has expanded API manufacturing capacities for protease inhibitors, including darunavir, targeting emerging markets.
• Mylan (now part of Viatris): Known for their focus on affordable antiretrovirals, Mylan claims to manufacture high-quality darunavir API for its generic HIV portfolio.
• Zhejiang Hisun Pharmaceutical (China): Has developed API manufacturing capabilities aligned with global regulatory standards, targeting both domestic and international markets.

3. Emerging and Regional API Producers

Several Asian API manufacturers are increasingly contributing to the global supply of darunavir API, often serving markets with less stringent regulatory environments initially:

• Sulphur Exports (India): Produces bulk APIs for multiple antiretrovirals, including darunavir, adhering to WHO-GMP standards.
• Sipra Labs (India): Offers competitively priced APIs, including protease inhibitors, with optional WHO prequalification.
• Shenzhen API Pharma (China): Recently expanded to include darunavir, targeting regional supply chains.

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Supply Chain Considerations

• Regulatory Compliance: Sourcing from approved GMP manufacturers is essential to ensure compliance with international standards, particularly for export to North America and Europe.
• Patent and Licensing Status: Although Janssen’s patent protections remain in certain jurisdictions, off-patent status in some emerging markets has increased the availability of generic APIs.
• Manufacturing Capacity & Lead Times: Capacity constraints among API producers can impact availability and pricing. Long-term contracts with credible suppliers mitigate risks.
• Quality Assurance & Validation: Batch-to-batch consistency and purity levels are crucial, especially when APIs are sourced from multiple vendors.

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Regulatory Landscape

Bringing darunavir to market requires APIs compliant with:

• U.S. FDA: GMP-certified API plants with validated specifications.
• EMA: Conformance with EudraLex and EMA guidelines.
• WHO Prequalification: For products meant for global health programs, WHO prequalification ensures the API meets international standards.

While Janssen’s API is fully compliant, many regional suppliers are working toward such certifications, enabling broader access.

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Industry Dynamics & Future Outlook

The market for darunavir API is influenced by:

• Patent Expiry: In markets where patents have expired, generic manufacturers dominate API supply, leading to price competition.
• Global HIV/AIDS Initiatives: UNAIDS and WHO’s procurement strategies fuel demand for affordable generics, expanding API sourcing from Indian and Chinese manufacturers.
• Manufacturing Innovations: Advanced synthesis and biocatalytic processes are improving yield, purity, and cost-efficiency.
• Supply Chain Disruptions: Global events like COVID-19 have highlighted vulnerabilities; diversification of API sources is critical.

The growing integration of API manufacturing facilities in India and China continues to streamline supply chains, reducing costs and improving availability.

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Key Factors for Stakeholders in API Sourcing

• Certifications & Compliance: Confirm API suppliers hold necessary GMP and WHO prequalification certifications.
• Technical Capabilities: Ensure manufacturers can replicate production processes that yield high-purity darunavir API.
• Supply Security: Establish long-term agreements with multiple suppliers to mitigate risks.
• Cost Competitiveness: Balance quality with pricing, especially for large-scale procurement.
• Regulatory Acceptance: Verify documentation for regulatory submission and inspection readiness.

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Conclusion

The sourcing landscape for PREZISTA’s darunavir API is evolving, with multiple regional and global suppliers contributing to a competitive market. Janssen’s API remains the benchmark, but advanced Asian manufacturers are increasingly offering high-quality alternatives, especially in off-patent markets. Stakeholders must prioritize regulatory compliance, supply security, and quality assurance to optimize procurement strategies in this dynamic environment.

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Key Takeaways

• Major API Sources: Janssen (innovator), Indian and Chinese CMOs (generics), regional manufacturers.
• Regulatory standards: GMP certification and WHO prequalification are critical for international markets.
• Market dynamics: Patent expiration and global HIV initiatives favor the growth of generic API manufacturing.
• Supply chain risks: Diversification and contractual agreements are essential to secure continuous supply.
• Industry innovation: Technological advances improve API yield, quality, and cost-effectiveness.

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FAQs

1. Who are the leading API manufacturers for darunavir?
Janssen Pharmaceuticals remains the primary supplier, with key generics produced by Indian companies such as Hetero, Cadila, and Mylan, alongside Chinese manufacturers like Shenzhen API Pharma.

2. What are the regulatory considerations for sourcing darunavir API?
Manufacturers must hold GMP certification, and for global markets, WHO prequalification or equivalent standards are vital to ensure quality and market acceptance.

3. How has patent expiration impacted darunavir API sourcing?
Patent expiry in several markets has expanded generic manufacturing, increasing the number of suppliers and improving pricing and supply stability.

4. What are the primary risks associated with API sourcing for PREZISTA?
Risks include supply disruptions due to capacity constraints, regulatory delays, quality inconsistencies, and geopolitical factors affecting manufacturing regions.

5. What trends are shaping the future of darunavir API supply?
Increased production in emerging markets, technological advancements in synthesis, and intensified efforts toward regulatory compliance will underpin the market’s evolution.

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References

1. Johnson & Johnson. PREZISTA (darunavir) prescribing information. 2022.
2. World Health Organization. Prequalification of Medicines Programme. 2023.
3. GlobalData. HIV/AIDS pharmaceuticals market report. 2022.
4. Indian Ministry of Commerce. API manufacturing capabilities. 2023.
5. European Medicines Agency. Regulatory guidelines for APIs. 2023.