Suppliers and packagers for prezista

prezista

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895	NDA	Janssen Products LP	59676-565-01	1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS	2011-12-16
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-562-01	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01)	2008-03-08
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-563-01	480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01)	2009-01-14
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-564-01	240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-564-01)	2009-04-27

Suppliers for the Pharmaceutical Drug: PREZISTA

Last updated: July 29, 2025

Introduction

PREZISTA (darunavir) is a protease inhibitor marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It is a key component in antiretroviral therapy for treating HIV-1 infection. As a critical drug in the HIV treatment landscape, understanding its supply chain, including primary suppliers and manufacturing sources, is vital for stakeholders, including healthcare providers, investors, and competitors.

This article offers an in-depth analysis of the suppliers involved in the production of PREZISTA, highlighting manufacturing paradigms, sourcing strategies, and recent industry developments to aid data-driven decision-making.

Manufacturing and Supply Chain for PREZISTA

PREZISTA’s active pharmaceutical ingredient (API), darunavir, is a complex molecule synthesized through a multi-step chemical process. Johnson & Johnson (J&J) sources raw materials and intermediates predominantly from global suppliers to ensure quality, cost-effectiveness, and continuous supply.

Primary Suppliers of Darunavir API

While J&J maintains strict control over its manufacturing processes, the API synthesis depends on a network of specialized chemical suppliers. These suppliers provide core intermediates, catalysts, and raw chemicals required for the complex synthesis process.

• Global Chemical Suppliers:
  Main API manufacturing plants for PREZISTA are located in strategic regions, including India, China, and Europe. The Indian pharmaceutical industry, notably companies like Cipla and Mylan, has historically been a significant player in producing generic versions and APIs for protease inhibitors, including darunavir.

• Key Raw Material Providers:
  The synthesis of darunavir involves specialized chemicals, such as substituted pyrimidines and other heterocyclic compounds. Suppliers for these chemicals include multinational corporations like BASF, Sigma-Aldrich (Merck), and other regional chemical producers, supplying intermediates used in API synthesis.

Manufacturing Facilities

While detailed manufacturer disclosures are limited due to confidentiality agreements, public regulatory filings reveal that the primary production of the API for PREZISTA occurs in facilities certified by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies.

• Johnson & Johnson's Manufacturing Plants:
  J&J’s facilities in the United States and Europe oversee the final formulation, packaging, and distribution, often sourcing APIs from third-party manufacturers.

• CMO (Contract Manufacturing Organization) Involvement:
  J&J contracts manufacturing to specialized CMOs in India and China to diversify risk and optimize costs, making these regions central to the production supply chain.

Distribution and Supply Chain Complexity

The global nature of pharmaceutical manufacturing introduces risks such as geopolitical instability, regulatory changes, and raw material shortages. These risks are mitigated through multi-sourcing and geographic diversification.

Recent Industry Developments and Supply Chain Sustainability

Recent supply chain disruptions, notably during the COVID-19 pandemic, prompted an emphasis on supply resilience for critical drugs like PREZISTA.

• Strategic Stockpiling:
  J&J increased inventory buffers to safeguard supply continuity amid global disruptions.

• Supply Chain Transparency:
  The company has engaged in initiatives to enhance transparency, including supplier audits and increased use of digital tracking systems.

• Supply Chain Localization:
  Efforts are underway to establish API production facilities within regions like North America and Europe to reduce reliance on Asian suppliers.

Regulatory and Patent Considerations Impacting Supply

Patent protections for PREZISTA are crucial in maintaining market exclusivity, impacting supply strategies. The expiration of key patents may lead to increased generic production, expanding the supplier base but also increasing competition.

• Patent Status:
  As of 2023, key patents for darunavir remain in force in major markets, limiting generic manufacturing to authorized or licensed entities.

• Biosimilar and Generic Competition:
  When patents expire, numerous generic manufacturers are poised to supply the drug, potentially altering the supplier landscape significantly.

Key Suppliers Overview Table

Supplier Type	Region	Notable Companies	Role in Supply Chain	Notes
API Manufacturers	India, China	Cipla, Mylan, Aurobindo	API synthesis	Many operate under CDMO models
Raw Material Suppliers	Global	BASF, Sigma-Aldrich	Chemical intermediates	Supply specialized chemicals
Formulation & Packaging	Europe, North America	J&J manufacturing units	Final drug production	Controlled by Johnson & Johnson

Strategic Sourcing and Supply Chain Risks

Despite J&J’s efforts to diversify sources, reliance remains on Asian API manufacturers, exposing the supply chain to political, regulatory, and pandemic-related risks. To mitigate these, strategic initiatives focus on regional alliances, dual sourcing, and local API production.

Future Outlook

The transition of supply chains toward regionalization and increased use of digital supply chain management technologies is expected. Enhanced transparency and contingency planning will further bolster security of supply for PREZISTA.

Additionally, upcoming patent expirations could lead to expanded generic supplier capacity, impacting pricing, market share, and supply dynamics. Stakeholders should monitor patent landscapes and manufacturing progresses of potential generic entrants.

Key Takeaways

• Johnson & Johnson relies on a global network of API suppliers, primarily located in India and China, for PREZISTA's active ingredient derivation.
• Supply chain resilience is a strategic priority, with efforts to diversify sourcing, increase regional manufacturing, and improve supply transparency.
• Contract manufacturing organizations play a significant role in maintaining supply, especially in API synthesis and final formulation.
• Patent protection remains critical; expiration may significantly alter the supplier landscape, increasing options from generic manufacturers.
• Industry trends indicate a move toward regionalized supply chains and digital tracking, which could bolster supply stability and reduce vulnerabilities.

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FAQs

1. Who are the main suppliers of PREZISTA’s API?

Major API suppliers include specialized chemical manufacturers in India and China, such as Aurobindo and Mylan, which produce darunavir intermediates under licensing agreements with Johnson & Johnson or through generic licensing.

2. How does Johnson & Johnson ensure the quality of its PREZISTA supply chain?

J&J maintains strict regulatory compliance, conducts regular supplier audits, and employs quality agreements with manufacturing partners, ensuring adherence to Good Manufacturing Practices (GMP) across its supply chain.

3. Are there alternative suppliers for PREZISTA in case of disruptions?

Yes. As patents expire, numerous generic manufacturers are expected to enter the market, increasing the number of suppliers and enhancing supply resilience.

4. What regulatory factors influence PREZISTA’s supply chain?

Patent protections, regulatory approvals, and manufacturing authorizations significantly influence supply chain dynamics, dictating when and where generics or biosimilars can enter the market.

5. What is the outlook for the supply chain of PREZISTA in the coming years?

The supply chain is likely to become more regionalized with increased use of digital technologies, with potential expansion of generic manufacturing post-patent expiry, leading to increased competition and supply flexibility.

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Sources

[1] Johnson & Johnson Official Website – PREZISTA product details
[2] FDA Drug Approval Records and Manufacturing Site Disclosures
[3] Industry reports on pharmaceutical supply chain diversification, 2022-2023
[4] Patent and market exclusivity data on HIV protease inhibitors
[5] Regulatory filings from Indian and Chinese pharmaceutical companies involved in API synthesis