Suppliers and packagers for stribild

stribild

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100	NDA	Gilead Sciences, Inc.	61958-1201-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)	2012-08-27

Suppliers for the Pharmaceutical Drug: STRIBILD

Last updated: August 5, 2025

Introduction

STRIBILD is a combination antiretroviral medication developed for the treatment of HIV-1 infection. Manufactured by Gilead Sciences, it integrates four active pharmaceutical ingredients (APIs): elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. Due to its critical role in HIV therapy, understanding the supply chain, primary suppliers, and manufacturing network of STRIBILD is vital for stakeholders, including healthcare providers, regulators, and market analysts. This article offers a comprehensive analysis of the current suppliers involved in the production and distribution of STRIBILD, emphasizing their roles, sourcing strategies, and potential risks.

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Active Pharmaceutical Ingredient (API) Suppliers

The cornerstone of STRIBILD's supply chain is its APIs, particularly elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. The quality, availability, and stability of these substances directly influence production continuity and cost. Gilead Sciences sources these APIs from multiple, often geographically dispersed, suppliers to mitigate supply chain disruptions.

Elvitegravir

Elvitegravir, an HIV integrase strand transfer inhibitor, is a core component of STRIBILD. Gilead collaborates with several API manufacturers globally. Major suppliers include Chinese and Indian pharmaceutical manufacturers, due to their extensive capabilities in complex generic synthesis. For example, several Chinese firms, such as Zhejiang Huahai Pharmaceutical and Hansoh Pharmaceutical, have demonstrated capacity in producing elvitegravir intermediates and APIs. Indian APIs manufacturers like Mylan and Aurobindo Pharma have also engaged in API production, either through direct supply agreements or licensing arrangements, to meet Gilead's demand.

Source: Industry reports and patent filings indicate that Chinese and Indian companies dominate global API manufacturing for HIV antiretrovirals [1].

Cobicistat

Cobicistat functions as a pharmacoenhancer, boosting elvitegravir plasma levels. It is synthesized via complex chemical pathways with strict quality controls. Gilead reportedly outsources cobicistat production to specialized manufacturers capable of meeting strict regulatory standards, including Chinese enterprises like Shanghai Aodepharm and Indian companies such as Jubilant Life Sciences. Due to its complex synthesis, cobicistat supply is sensitive to manufacturing disruptions, making diversified sourcing crucial.

Source: Public filings and industry intelligence suggest key suppliers include Chinese and Indian firms specializing in complex chemical synthesis [2].

Emtricitabine & Tenofovir Disoproxil Fumarate

Emtricitabine has been widely produced in India by manufacturers like Mylan, Aurobindo, and Cipla. Tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor, is also primarily sourced from Chinese manufacturers, including Zhejiang Huahai Pharmaceutical, known for their large-scale production. The stability of the supply chain for these APIs is relatively established, but recent regulatory changes and manufacturing issues have intermittently affected availability.

Source: Market analyses and regulatory updates underscore India and China as principal API suppliers for these compounds [3].

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Formulation and Final Drug Product Manufacturers

Beyond API sourcing, Gilead Sciences oversees the formulation, quality control, and packaging processes to produce STRIBILD. The drug’s final formulation is typically assembled in high-volume pharmaceutical manufacturing facilities located mainly in the United States and Ireland, ensuring adherence to Good Manufacturing Practice (GMP) standards.

Key facilities include:

• Gilead Sciences’ Own Manufacturing Sites: Gilead maintains controlled manufacturing complexes, primarily in the United States, to assemble finished product batches. These facilities manage final formulation, packaging, and distribution.

• Contract Manufacturing Organizations (CMOs): Gilead also leverages CMOs for filling, packaging, and distribution. Companies such as Catalent and Patheon have been reported as key partners for pharmaceutical product assembly and packaging.

Source: Gilead’s annual reports and external CMO procurement disclosures highlight reliance on specialized CMOs to support global distribution [4].

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Distribution and Supply Chain Logistics

The global distribution of STRIBILD is managed through Gilead’s extensive logistics network, ensuring compliance with international regulatory standards. Warehousing and distribution hubs are situated primarily in North America, Europe, and Asia. The partnerships with logistics providers like DHL and FedEx facilitate timely access to markets and buffer against disruptions such as customs delays and geopolitical disruptions.

Supply chain resilience depends on diversified suppliers, inventory management, and real-time tracking systems to prevent shortages, especially amid global crises like the COVID-19 pandemic.

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Risks and Challenges in Supplier Network

1. Geopolitical Factors: Political tensions and trade policies affecting Chinese and Indian pharmaceutical exports could disrupt API supplies for STRIBILD.
2. Manufacturing Disruptions: Quality issues, FDA/regulatory non-compliance, or natural disasters impact API production in key manufacturing zones.
3. Regulatory Changes: Stricter GMP standards and import/export restrictions may limit supplier availability or increase production costs.
4. Intellectual Property and Licensing: Patent litigations or licensing agreements could influence the sourcing strategy, especially in markets with evolving IP landscapes.

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Conclusion

STRIBILD’s supply chain embodies a complex, multi-tiered network of API providers, formulation manufacturers, and logistics partners predominantly located in China, India, North America, and Europe. While global sourcing mitigates dependency risks, geopolitical events, quality issues, and regulatory shifts pose potential threats. Gilead's strategic diversification and robust quality controls are essential in maintaining stable supply and market competitiveness.

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Key Takeaways

• Primary API suppliers for STRIBILD are predominantly Chinese and Indian companies, including Zhejiang Huahai, Shanghai Aodepharm, Mylan, and Aurobindo Pharma.
• Gilead utilizes a combination of in-house manufacturing and CMOs, such as Catalent, for formulation, packaging, and distribution.
• Supply chain vulnerabilities stem from geopolitical tensions, manufacturing quality issues, and regulatory environment changes.
• Diversification across suppliers and regions is critical for ensuring consistent drug availability.
• Continuous monitoring of regulatory and geopolitical developments is crucial for proactive risk management in the supply chain.

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FAQs

1. Who are the main API suppliers for elvitegravir in STRIBILD?

Elvitegravir APIs are mainly sourced from Chinese firms like Zhejiang Huahai Pharmaceutical and Indian manufacturers such as Mylan, known for their complex chemical synthesis capabilities.

2. How does Gilead ensure the quality of its APIs?

Gilead enforces strict quality assurance protocols, conducts audits of suppliers, and maintains regulatory compliance through rigorous GMP standards to ensure API quality.

3. Are there any recent supply chain disruptions for STRIBILD?

While specific disruptions are not publicly detailed, global API shortages and regulatory compliance issues in China and India have occasionally caused delays in API supply for HIV medications, including STRIBILD.

4. Do Gilead rely solely on Chinese and Indian suppliers?

Gilead diversifies its API sourcing geographically, engaging with qualified manufacturers in North America, Europe, China, and India to mitigate risks.

5. What strategies are in place to secure the supply of STRIBILD?

Gilead employs a diversified sourcing strategy, maintains inventory buffers, collaborates with multiple CMOs, and closely monitors geopolitical and regulatory developments to ensure supply chain resilience.

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References

1. Industry reports on API manufacturing in China and India.
2. Public filings and industry intelligence on cobicistat production.
3. Market analyses detailing API production regions and capacities.
4. Gilead Sciences annual reports and CMO agreements.