Suppliers and packagers for INTELENCE

INTELENCE

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 R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Patriot Pharmaceuticals	10147-0570-1	120 TABLET in 1 BOTTLE, PLASTIC (10147-0570-1)	2025-04-01
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Patriot Pharmaceuticals	10147-0571-1	60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)	2025-04-01
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Janssen Products LP	59676-570-01	120 TABLET in 1 BOTTLE, PLASTIC (59676-570-01)	2008-01-18

Suppliers for the Pharmaceutical Drug: Intelence (Elvitegravir)

Last updated: July 27, 2025

Introduction

Intelence, the brand name for Elvitegravir, is a potent integrase strand transfer inhibitor (INSTI) used primarily in combination therapies for treating HIV-1 infections. Since its approval by the FDA in 2012, Intelence has become a cornerstone in HIV management, especially due to its efficacy in treatment-experienced patients. As a high-demand antiretroviral, its supply chain involves a complex array of suppliers spanning active pharmaceutical ingredients (APIs), intermediates, excipients, and finished product manufacturing. This article examines the current landscape of key suppliers for Intelence, exploring their roles, capacities, and the strategic implications for stakeholders.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Focused U.S. and European API Manufacturers

The core of Intelence’s supply chain depends heavily on specialized API producers with capacities to synthesize Elvitegravir at high purity standards required for pharmaceuticals.

• Shenzhen�SinoPharm (China):
  A prominent provider of APIs in the Asia-Pacific region, SinoPharm’s research-driven facilities supply Elvitegravir APIs under contract manufacturing agreements. Their expertise lies in complex organic syntheses pertinent to INSTIs, with certifications complying with Good Manufacturing Practice (GMP) standards.

• Hetero Labs Ltd. (India):
  Hetero is a major API manufacturer with validated processes for complex molecules like Elvitegravir. Their capacity spans large-scale production, and they are known for cost-effective quality assurance and reliable supply, making them a preferred external partner for pharmaceutical companies.

• Mourik Pharma (China):
  Mourik offers custom synthesis and scale-up capabilities for Elvitegravir as an API, especially focusing on supply stability and compliance with international regulatory standards.

2. Contract Manufacturing Organizations (CMOs)

Several large CMOs globally have facilities dedicated to API production for antiretroviral drugs:

• Lonza Group (Switzerland):
  Known for high-purity API manufacturing, Lonza has the technical capacity to produce Elvitegravir at commercial scale. They offer integrated services from synthesis to quality control, ensuring supply security.

• Samsung Biologics (South Korea):
  While primarily known for biologics, Samsung’s expanding portfolio includes small molecule APIs like Elvitegravir, leveraging their state-of-the-art manufacturing facilities.

• Suzhou API Co. Ltd. (China):
  Specializes in complex small molecules, including INSTIs. Their GMP-certified plants support global distribution needs.

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Finished Dosage Form Manufacturers

Once the API is procured, it is formulated into tablets.

• Gilead Sciences Manufacturing Facilities:
  As the originator of Intelence, Gilead maintains manufacturing plants certified under international standards, with internal API sourcing and final product assembly to meet global demand.

• Contract manufacturers (CMOs):
  Many pharmaceutical companies contract Asian CMOs with capacity for high-volume oral solid dosage form manufacturing, including tablets containing Elvitegravir.

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Excipients and Packaging Suppliers

Secure supply of excipients such as binders, fillers, and coating agents is crucial for product stability and compliance.

• Colorcon Inc. (USA):
  Supplies high-quality excipients tailored for antiretroviral tablets.

• DOW Chemical (USA):
  Provides pharmaceutical-grade polymers essential for controlled-release formulations, if applicable.

• Packaging Suppliers:
  Companies like Gerresheimer (Germany) supply blister packs and bottles conforming to tamper-evident and stability requirements.

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Supply Chain Challenges and Strategic Considerations

The COVID-19 pandemic exposed vulnerabilities in global supply chains for pharmaceuticals. Particularly for drugs like Intelence, supply relies on specialized API producers predominantly based in Asia, leading to risks of regulatory delays, geopolitical tensions, and raw material shortages.

To mitigate such risks:

• Diversification of API sourcing
  Suppliers should expand geographically to include multiple regions such as North America, Europe, and Asia.

• Vertical integration
  Larger pharma companies might consider in-house API synthesis or establishing strategic alliances with key suppliers to ensure continuity.

• Regulatory preparedness
  Suppliers must maintain rigor in GMP compliance and documentation to ensure regulatory approval across jurisdictions, including the FDA, EMA, and WHO.

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Emerging Trends in Supplier Ecosystems

• Adoption of Contract Manufacturing with Sustainability Focus
  Suppliers are increasingly incorporating sustainable practices, reducing carbon footprints, and improving traceability, which is vital for sensitive drugs like Intelence.

• Use of Advanced Technologies
  Companies are applying continuous flow chemistry and green synthesis techniques in API production to enhance efficiency and reduce environmental impact.

• Partnerships with Biotech Startups
  Collaborations are expanding towards novel synthesis routes and formulation innovations to improve drug stability and reduce manufacturing costs.

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Conclusion

The supply landscape for Intelence hinges on a network of specialized API manufacturers, contract manufacturers, and excipient providers spanning global regions. Key API suppliers include Hetero Labs, SinoPharm, Mourik Pharma, and CMOs like Lonza and Samsung Biologics. Ensuring supply resilience demands diversification, strategic inventory management, and adherence to regulatory standards. As demand for HIV therapeutics persists, and global health priorities evolve, supply chains must adapt to guarantee uninterrupted access to this vital medication.

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Key Takeaways

• The integrity of Intelence’s supply chain depends on strategic relationships with established API manufacturers in Asia and Europe.
• Diversification and vertical integration are crucial for mitigating risks associated with geopolitical and logistical disruptions.
• Regulatory compliance and quality assurance are paramount, especially given the complex synthesis of Elvitegravir.
• Emerging technological innovations and sustainability initiatives are shaping future supplier practices.
• Stakeholders should monitor geopolitical developments and ensure supplier certifications to safeguard supply security.

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FAQs

1. Who are the main API suppliers for Intelence?
Hetero Labs (India), SinoPharm (China), Mourik Pharma (China), and contract manufacturers like Lonza are primary API suppliers.

2. Is Intelence manufactured solely by Gilead Sciences?
While Gilead owns the brand, API procurement and final formulation often involve multiple contract manufacturing organizations globally.

3. What are the risks associated with Intelence’s supply chain?
Risks include supplier concentration, geopolitical tensions, raw material shortages, and regulatory delays, especially in Asia.

4. How are suppliers ensuring compliance with international standards?
Through GMP certifications, regular audits, and adherence to evolving regulatory guidelines from agencies like the FDA, EMA, and WHO.

5. Are there efforts to localize the supply of Intelence?
Yes, strategic partnerships and investments aim to diversify geographic sources and establish regional manufacturing hubs to improve supply resilience.

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Sources

[1] U.S. Food and Drug Administration (FDA). Intelence (Elvitegravir) Prescription Information.
[2] Gilead Sciences Inc. Official site. Manufacturing and Supply Chain Overview.
[3] Chemical & Pharmaceutical Industry Reports. API Market Analysis.
[4] Contract Manufacturing Associations. Global API Production Capacity.
[5] Industry Publications on Supply Chain Resilience in Pharmaceuticals.