Suppliers and packagers for PREZCOBIX

PREZCOBIX

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	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	A-S Medication Solutions	50090-1723-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)	2015-01-31
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	Janssen Products LP	59676-575-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30)	2015-01-31
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395	NDA	Janssen Products LP	59676-578-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-578-30)	2025-03-21

Suppliers for the Pharmaceutical Drug: Prezcobix

Last updated: July 30, 2025

Introduction

Prezcoix, marketed under the brand name Prezcobix, is a prescription medication used in the management of HIV infection. It combines two active pharmaceutical ingredients (APIs): darunavir, an antiretroviral protease inhibitor, and cobicistat, a pharmacokinetic enhancer that boosts darunavir’s efficacy. As a critical component in HIV therapy, Prezcobix's manufacturing and supply chain are tightly controlled, involving complex relationships with multiple suppliers of raw materials, active pharmaceutical ingredients (APIs), and finished drug products.

Understanding the key suppliers for Prezcobix is crucial for stakeholders involved in supply chain management, pharmaceutical procurement, and pharmaceutical manufacturing. This report offers a comprehensive overview of the provider landscape for Prezcobix, highlighting major API suppliers, manufacturing partnerships, and production regulations.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Darunavir

Darunavir, the principal component of Prezcobix, is a second-generation protease inhibitor. Its global production is concentrated among a handful of high-capacity pharmaceutical API suppliers capable of meeting the stringent quality standards required for HIV medication.

Leading Darunavir Suppliers:

• Shenzhen Yuming Pharmaceutical Co. Ltd. (China): A notable API manufacturer with significant production capacity for darunavir, supplying both domestic and international markets.
• Hetero Labs Limited (India): One of the largest generic API producers, Hetero supplies darunavir to multiple markets under different formulations.
• Mylan N.V. (now part of Viatris): Historically engaged in the production of APIs for various antiretroviral agents, including darunavir.
• Cipla Limited (India): Engaged in producing APIs and finished dosage forms, including darunavir, serving both global generic markets and branded formulations.

Regulatory Compliance & Certification: Suppliers must comply with Good Manufacturing Practice (GMP) standards set by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Many suppliers possess approvals or certifications indicating compliance with these standards, facilitating international distribution.

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2. Cobicistat

Cobicistat functions as a pharmaco-enhancer in Prezcobix, inhibiting CYP3A enzymes to increase darunavir plasma concentrations.

Major Cobicistat Suppliers:

• Jiangsu Hengrui Medicine Co., Ltd. (China): Among the leading developers and producers of cobicistat derivatives, Hengrui maintains GMP-certified manufacturing facilities.
• Boehringer Ingelheim (Germany): A pioneer in developing cobicistat, providing both active ingredients and finished formulations.
• Thermo Fisher Scientific (USA): Supplies pharmaceutical intermediates and APIs, including cobicistat, under strict quality controls.
• Kelun Pharmaceutical (China): Produces cobicistat-related compounds with increasing global distribution.

Regulatory & Quality Assurance: Major suppliers hold approval from global regulators, including FDA and EMA, and adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards.

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Manufacturing Collaborations and Contract Manufacturing Organizations (CMOs)

The complexity of HIV medication production often involves multiple contract manufacturers and strategic partnerships. Key players include:

• Hetero Labs Limited: Not only supplies APIs but also partners with global firms for formulation and finished-dose manufacturing.
• Cipla Ltd.: Operates several manufacturing facilities responsible for both API synthesis and finished product assembly.
• Mylan (Viatris): Uses a network of CMOs for production of Prezcobix’s components, ensuring scalability and global distribution capacity.
• Pharma & Biotech CMOs: Several top-tier CMOs, including Lonza and Catalent, support formulation and packaging, enabling large-scale production with regulatory compliance.

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Supply Chain Considerations & Regulatory Environment

The supply chain integrity for Prezcobix relies on robust vendor oversight, rigorous quality control, and compliance with international regulatory standards. Due to the critical nature of HIV therapy, shortages or disruptions can significantly impact patient health outcomes.

Key considerations include:

• Raw Material Sourcing: Suppliers must ensure the purity and traceability of APIs, with certifications such as Certificates of Analysis (CoA).
• Regulatory Approvals: Suppliers with approvals from stringent regulatory authorities (e.g., FDA, EMA, PMDA) facilitate smoother global distribution.
• Manufacturing Capacity: Capacity constraints or geopolitical issues in China and India, primary API manufacturing hubs, can influence supply stability.
• Patent and Exclusivity Status: Patent protections in key markets can influence supplier engagement and price negotiations.

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Strategic Implications for Stakeholders

For pharmaceutical companies and healthcare providers, sourcing from reputable, compliant API suppliers reduces risk and ensures continuous supply. Engaging with suppliers holding global regulatory approvals mitigates compliance and quality issues, reducing the risk of drug recalls or shortages.

Additionally, as the HIV landscape shifts towards more affordable generics and biosimilars, diversification of supply sources becomes increasingly relevant. Strategic partnerships, contract manufacturing, and quality assurance frameworks should be prioritized in procurement strategies.

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Conclusion

Prezcoix’s supply chain is anchored by a select group of high-quality API producers specializing in darunavir and cobicistat, primarily located in China and India. Regulatory compliance, manufacturing capacity, and geopolitical stability remain key considerations influencing supplier selection and supply security. As demand for HIV treatments persists globally, continuous monitoring of supplier capabilities and regulatory statuses will be essential for maintaining a resilient supply chain.

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Key Takeaways

• The core API suppliers for Prezcobix are Shenzhen Yuming, Hetero Labs, Cipla, Jiangsu Hengrui, and Boehringer Ingelheim.
• Cobicistat suppliers include Jiangsu Hengrui, Boehringer Ingelheim, and Thermo Fisher Scientific.
• GMP certification and regulatory approvals are critical factors in supplier selection.
• Partnerships with CMOs enable scalable, compliant manufacturing of Prezcobix.
• Maintaining supply chain resilience requires diversification and stringent quality oversight.

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FAQs

1. Who are the primary API manufacturers for Prezcobix?
Major API suppliers include Shenzhen Yuming Pharmaceutical (darunavir) and Jiangsu Hengrui Medicine (cobicistat), both holding GMP certifications and regulatory approvals for international markets.

2. How does regulatory approval affect supplier choice?
Regulatory approvals from authorities like the FDA or EMA ensure the supplier’s manufacturing processes meet strict quality standards, reducing compliance risks and facilitating global distribution.

3. Are there geopolitical risks affecting Prezcobix supply?
Yes, reliance on Chinese and Indian API manufacturers introduces geopolitical and logistical considerations, including trade policies and manufacturing disruptions.

4. What role do contract manufacturing organizations play?
CMOs facilitate large-scale, compliant formulation, packaging, and distribution, ensuring scalable and cost-efficient production aligned with regulatory standards.

5. How can supply chain disruptions be mitigated?
Diversifying supplier sources, establishing long-term procurement agreements, and maintaining inventory buffers can mitigate risks of shortages in Prezcobix supply.

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Sources:

[1] U.S. Food and Drug Administration (FDA) Database.
[2] European Medicines Agency (EMA) Product Approvals.
[3] Company websites: Hetero, Jiangsu Hengrui, Boehringer Ingelheim, Cipla.
[4] Industry reports on API manufacturing capacity and supply chain analysis.