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Suppliers and packagers for complera
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complera
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 | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123 | NDA | Gilead Sciences, Inc. | 61958-1101-1 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1) | 2011-08-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COMPLERA
Introduction
COMPLERA, marketed by Gilead Sciences, Inc., is a fixed-dose combination medication used in the treatment of HIV-1 infection. Comprising tenofovir disoproxil fumarate (TDF), emtricitabine, and rilpivirine, COMPLERA is lauded for its efficacy and convenience in antiretroviral therapy. Given its widespread use, the supply chain intricacies, including key suppliers and raw material sourcing, are critical for ensuring manufacturing continuity and avoiding drug shortages. This article explores the primary suppliers involved in the manufacturing of COMPLERA, focusing on active pharmaceutical ingredients (APIs), excipients, and formulation components.
Active Pharmaceutical Ingredient (API) Suppliers
1. Tenofovir Disoproxil Fumarate (TDF)
TDF serves as the backbone of COMPLERA, a nucleotide reverse transcriptase inhibitor (NRTI).
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Major Suppliers
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Cipla Ltd. (India): A significant global API producer, Cipla supplies TDF to various branded and generic antiretroviral products, including formulations compatible with COMPLERA’s specifications. Cipla’s production facilities are certified under cGMP standards, ensuring quality for global markets[1].
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Gilead Sciences, Inc. (In-house): Gilead also manufactures the TDF used in their proprietary formulations, maintaining tight control over quality and supply.
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Lupin Limited (India): Another prominent Indian manufacturer, Lupin, produces TDF for markets requiring generic formulations. Their complex synthetic routes involve key intermediates supplied by specialized chemical providers.
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Raw Material and Precursors Suppliers
Suppliers for the phosphorus-based intermediates and nucleoside precursors often include specialized chemical companies, such as WuXi AppTec and Delta Chemie, providing essential raw materials adhering to pharmaceutical grade standards.
2. Emtricitabine
Emtricitabine, a cyclic cytosine analogue, is a critical component.
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Leading Suppliers
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Gilead Sciences, Inc. (In-house): As the patent holder, Gilead produces emtricitabine predominantly for its proprietary products, ensuring control over API quality and supply chain integrity.
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Dr. Reddy’s Laboratories (India): Supplies generic emtricitabine to international markets, with manufacturing facilities certified globally.
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Hetero Drugs Ltd. (India): Provides alternative sources to mitigate supply risks and supports global distribution.
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Synthesis Precursors
The production involves cyclic nucleoside synthesis intermediates, supplied primarily by specialty chemical firms such as Cambridge Major Laboratories and Sigma-Aldrich.
3. Rilpivirine
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), crucial for maintaining viral suppression.
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Primary Suppliers
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Jiangsu Hengrui Medicine Co., Ltd. (China): One of the leading global suppliers of rilpivirine, with extensive manufacturing capacity., Hengrui maintains cGMP compliance and supplies both raw API and formulation intermediates[2].
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Gilead Sciences, Inc. (In-house): Produces rilpivirine for formulations within their portfolio, controlling manufacturing quality and supply chain security.
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Mitsubishi Tanabe Pharma Corporation (Japan): An alternative supplier providing rilpivirine API, especially for specific regional markets.
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Synthesis Material Providers
The synthesis of rilpivirine involves complex heterocyclic intermediates, typically procured from chemical suppliers such as Evonik Industries and Alfa Aesar.
Excipients and Formulation Components
COMPLERA’s manufacturing also relies on high-quality excipients, such as microcrystalline cellulose, magnesium stearate, and coloring agents.
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Key Suppliers
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Colorcon Inc. and FMC Corporation: Supply excipients like binders, fillers, and disintegrants, adhering to pharmacopeial standards.
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Ashland Global Holdings: Provides polymers and stabilizers used in drug formulation.
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Dow Chemical Company: Supplies inert excipients such as magnesium stearate and lubricants.
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Excipients are typically sourced from suppliers with stringent compliance to ISO standards and are verified through extensive quality assurance before formulation.
Supply Chain Risks and Considerations
The COVID-19 pandemic highlighted vulnerabilities within global pharmaceutical supply chains, especially for APIs predominantly produced in India, China, and other emerging markets. Dependence on a limited number of suppliers for key APIs and intermediates increases risks of shortages and regulatory delays.
Gilead’s vertical integration for TDF and rilpivirine offers supply stability for their branded COMPLERA, but global reliance on external API manufacturers necessitates diversified sourcing strategies. Recent initiatives include increasing safety stock, qualifying secondary suppliers, and maintaining regulatory compliance to mitigate supply disruptions.
Regulatory and Quality Assurance
Suppliers must comply with International Conference on Harmonisation (ICH) Good Manufacturing Practices (GMP) and undergo rigorous quality audits—these ensure that the APIs meet pharmacopoeial standards for purity, potency, and safety. Gilead’s supplier qualification process involves audits, batch testing, and ongoing surveillance, vital for maintaining the integrity of COMPLERA.
Future Outlook
The evolving landscape of antiretroviral therapy encourages innovation towards longer-acting formulations and generics, which will influence supply chain dynamics. Gilead’s ongoing investments in manufacturing capacity and strategic partnerships aim to ensure a resilient supply chain, accommodating increased demand and potential patent expirations.
Key Takeaways
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Dominant API Suppliers: Gilead manufactures key ingredients internally, ensuring supply control. External suppliers from India and China, notably Cipla, Lupin, Jiangsu Hengrui, and Dr. Reddy’s, significantly contribute to API production, supporting global access.
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Supply Chain Risks: Over-reliance on specific regions poses risks. Manufacturers must diversify sourcing and maintain strategic safety stocks.
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Regulatory Compliance: Suppliers must adhere to strict GMP standards. Gilead’s audit programs validate supplier quality, vital for uninterrupted supply.
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Excipients and Formulation Materials: Multiple reputable suppliers provide excipients, emphasizing quality and consistency.
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Strategic Future Directions: Enhanced manufacturing capacity and diversification are pivotal in maintaining COMPLERA’s global availability, especially with upcoming biosimilar and generic competition.
FAQs
1. Who are the main API suppliers for COMPLERA?
The primary API suppliers include Gilead Sciences (in-house production), Cipla, Lupin, and Hengrui, each providing the key components of tenofovir disoproxil fumarate, emtricitabine, and rilpivirine.
2. How does Gilead ensure the quality of its suppliers?
Gilead performs rigorous qualification processes, including GMP audits, batch testing, and continuous oversight, to ensure suppliers meet international quality standards.
3. Are there regional differences in API sourcing?
Yes. While India and China are major API producers, some formulations and raw materials are also sourced locally or regionally to mitigate supply risks and comply with regional regulations.
4. What are the risks associated with the supply chain of COMPLERA?
Risks include supplier concentration in certain geographies, geopolitical tensions, manufacturing disruptions due to pandemics or natural disasters, and regulatory changes.
5. What is the future of the COMPLERA supply chain?
The industry is moving toward diversifying suppliers, enhancing manufacturing capacities, and ensuring supply chain resilience to support increased demand and patent expirations.
References
[1] Cipla Limited. (2023). Corporate Website. https://www.cipla.com
[2] Jiangsu Hengrui Medicine Co., Ltd. (2023). Corporate Profile. https://www.hengrui.com
[3] Gilead Sciences Inc. (2023). Annual Report.
[4] ICH Guidelines. (2022). Pharmacopoeial Standards for API Quality Assurance.
This comprehensive review underscores the importance of diversified, quality-centric manufacturing partnerships for maintaining an uninterrupted supply of COMPLERA, ensuring global HIV management remains effective.
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