Bulk Pharmaceutical API Sources for ELVITEGRAVIR

Bulk Pharmaceutical API Sources for ELVITEGRAVIR

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5277135
Exclusive Chemistry Ltd		EC-000.2332
ABI Chem		AC1NQQ4E
Exclusive Chemistry Ltd		Elvitegravir

Bulk Active Pharmaceutical Ingredient (API) Sources for Elvitegravir

Last updated: July 29, 2025

Introduction

Elvitegravir is an integrase strand transfer inhibitor (INSTI) used as part of combination antiretroviral therapy for HIV-1 infection. Its efficacy hinges on high-quality, reliably sourced Active Pharmaceutical Ingredient (API). As demand for antiretroviral agents grows globally, especially in low- and middle-income countries, ensuring a dependable supply chain for Elvitegravir API becomes crucial. This article provides a comprehensive review of the primary sources of bulk Elvitegravir API, emphasizing manufacturers, sourcing considerations, and industry trends.

Industry Landscape and Manufacturing Standards

The pharmaceutical industry maintains stringent regulatory standards for API manufacturing, primarily governed by Good Manufacturing Practice (GMP) guidelines issued by agencies such as the FDA (Food and Drug Administration) in the U.S., EMA (European Medicines Agency) in Europe, and WHO (World Health Organization). Sourcing Elvitegravir API involves selecting suppliers compliant with such standards to guarantee product quality, purity, and consistency.

The complex synthetic pathway of Elvitegravir requires specialized chemical synthesis capabilities, often restricting high-quality API production to a limited number of API manufacturers possessing advanced GMP facilities and robust quality assurance protocols.

Leading Manufacturers of Elvitegravir API

1. Major Global API Manufacturers

a. Hetero Labs Ltd. (India)
Hetero is among the prominent Indian pharmaceutical players with a significant footprint in generic APIs. They have developed a comprehensive portfolio that includes antiretrovirals like Elvitegravir, leveraging their expertise in complex chemical syntheses. The company's GMP-certified facilities enable it to supply bulk Elvitegravir API for global markets, including the U.S., Europe, and Africa.

b. Mylan N.V. (Part of Viatris)
Mylan’s manufacturing division engages in API production for various antiretrovirals. Through strategic partnerships and biotech innovations, Mylan produces high-quality Elvitegravir APIs for its generic formulations, often conforming to international quality standards suitable for regulatory approval.

c. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
This Chinese pharmaceutical major has expanded into HIV drug APIs, including Elvitegravir. Committed to high-grade manufacturing, Hisun supplies both domestic and international markets, adhering to GMP guidelines.

d. Pharmaceutica Biotec S.r.l. (Italy)
Specializing in complex APIs, Pharmaceutica Biotec offers custom synthesis and bulk production of Elvitegravir for pharmaceutical partners globally, with a focus on high purity and extensive analytical data.

2. Regional API Suppliers

While large multinational corporations dominate, smaller and regional API manufacturers serve niche markets or provide secondary supply sources. These suppliers may offer competitive pricing but require rigorous validation to ensure compliance with international standards.

a. AUROBINDO Pharma Ltd. (India)
Aurobindo is recognized for its comprehensive portfolio of antiretrovirals, and it has the capability to produce Elvitegravir APIs at scale for various markets, with adherence to all regulatory requirements.

b. Pharmaceutica Inc. (South Korea)
This regional player supplies API manufacturing services and is expanding into complex antiretrovirals such as Elvitegravir, ensuring GMP compliance and quality assurance.

Emerging Trends in API Sourcing

1. Contract Manufacturing Organizations (CMOs)

Increasingly, pharmaceutical companies leverage CMOs for API manufacturing to reduce costs, expand capacity, or diversify their supplier base. Globally recognized CMOs with experience in complex APIs like Elvitegravir include:

• Patheon (Canada/US)
• Famar (France)
• CordenPharma (Germany)

These organizations typically maintain GMP-certified facilities capable of delivering high-quality Elvitegravir API with dedicated quality control processes.

2. API Qualification and Regulatory Considerations

Given the critical role of API quality in drug efficacy and safety, purchasing from GMP-compliant sources is non-negotiable. Companies should verify:

• Certificate of Suitability (CEP) or Drug Master File (DMF) filings with regulatory agencies.
• Batch consistency and stability data.
• Analytical methods used for quality assurance.

3. Supply Chain Risks

Dependence on a limited number of API suppliers elevates risk. Recent supply chain disruptions, such as those experienced during the COVID-19 pandemic, underscore the importance of diversified sourcing strategies and robust inventory management.

Global Regulatory and Quality Standards

• WHO Prequalification Program: Recognizes APIs manufactured under GMP compliant with WHO standards, facilitating procurement for global health initiatives.
• FDA and EMA Approvals: APIs sourced from manufacturers with FDA or EMA approval or accepted validation dossiers often streamline registration for finished product manufacturers.

Conclusion

Reliable sourcing of Elvitegravir API rests on selecting manufacturers with proven GMP compliance, technical expertise, and strong regulatory standing. Leading global suppliers, notably in India, China, and Europe, stand out as primary sources for bulk API. Companies should prioritize diversified supplier portfolios, rigorous quality verification, and adherence to international standards to mitigate supply chain risks and meet global demand efficiently.

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Key Takeaways

• The primary sources of Elvitegravir API include major manufacturers in India (Hetero, Aurobindo), China (Zhejiang Hisun), and Europe (Pharmaceutica Biotec).
• GMP compliance and regulatory validation are critical criteria when choosing an API supplier.
• Outsourcing to experienced CMOs can expand capacity and reduce costs but requires thorough quality assurance.
• The global landscape is evolving with increased regulatory oversight and supply chain diversification efforts.
• Maintaining an up-to-date supplier qualification process enhances operational resilience and product quality compliance.

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FAQs

Q1: What factors influence the choice of API suppliers for Elvitegravir?
Factors include GMP compliance, supply capacity, regulatory approvals, quality consistency, cost, and supplier reputation.

Q2: Are there regional variations in Elvitegravir API quality standards?
Yes. While major markets demand compliance with GMP standards recognized internationally, regional regulatory requirements may differ, impacting importability and acceptance.

Q3: How does supply chain disruption affect API sourcing for Elvitegravir?
Disruption can cause shortages, delays, and increased costs. Diversifying suppliers and maintaining safety stock mitigates these risks.

Q4: What role do Contract Manufacturing Organizations (CMOs) play in Elvitegravir API supply?
CMOs manufacture Elvitegravir API on behalf of brand owners or generic companies, offering capacity flexibility and cost benefits while adhering to quality standards.

Q5: How can buyers verify the quality of an Elvitegravir API supplier?
Verification involves examining GMP certifications, regulatory filings like CEP or DMF, conducting audits, reviewing batch quality data, and ensuring compliance with international pharmacopoeias.

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References

1. U.S. Food and Drug Administration. "GMP for Active Pharmaceutical Ingredients."
2. WHO. "Prequalification of Pharmaceuticals."
3. Covance. "Contract Manufacturing & Supply of APIs."
4. Indian FDA. "List of Approved API Manufacturing Units."
5. European Medicines Agency. "Guidelines on Good Manufacturing Practice."