Bulk Pharmaceutical API Sources for INTELENCE

Bulk Pharmaceutical API Sources for INTELENCE

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A818671
BioChemPartner		BCP0726000193
BioChemPartner		BCP9000006

Bulk Active Pharmaceutical Ingredient (API) Sources for Intelence (Etravirine)

Last updated: July 27, 2025

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Introduction

Intelence (Etravirine) is an antiretroviral medication classified as a non-nucleoside reverse transcriptase inhibitor (NNRTI) used primarily in the treatment of HIV-1 infection. As a critical component in HIV therapy, the quality, sourcing, and supply of its active pharmaceutical ingredient (API) are crucial for pharmaceutical manufacturers seeking to ensure efficacy, safety, and regulatory compliance. This article examines key sources of bulk API for Intelence, emphasizing reputable suppliers, manufacturing standards, and industry trends essential for supply chain resilience.

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Overview of Etravirine API

Etravirine (ETR), chemically known as (S)-1-[(4-ethoxyphenyl) methyl]-4-[(2,4,6-trifluorophenyl) methyl]-6-(phenylamino)pyrimidin-2-one, possesses complex synthetic pathways. Its synthesis involves multi-step chemical processes requiring high purity and strict quality controls to meet pharmacopeial standards such as USP, EP, and JP.

The API’s core manufacturing challenges include controlling stereochemistry, impurity profiles, and batch-to-batch consistency. As such, sourcing from reliable suppliers with proven compliance to Good Manufacturing Practices (GMP) is essential.

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Leading API Suppliers for Etravirine (Intelence)

1. Global Big Pharma API Manufacturers

Several well-established pharmaceutical API producers supply Etravirine, often as part of their antiviral portfolios.

a. Hetero Labs Ltd
Based in India, Hetero is a leading API manufacturer with a robust portfolio in antiretroviral APIs. The company holds multiple GMP certifications and supplies APIs globally, including Etravirine for drug developers seeking consistent quality. Their manufacturing facilities adhere to stringent regulatory standards, and they possess capability for large-scale production [1].

b. Dr. Reddy’s Laboratories
Another major Indian pharmaceutical company, Dr. Reddy’s, manufactures and supplies APIs for antiretroviral drugs, including Etravirine. Their compliance with international standards like EMA and FDA approvals makes them a reliable source for bulk API.

c. Cipla Limited
Cipla manufactures APIs in addition to finished formulations, offering high-quality Etravirine for global markets. Their manufacturing processes comply with global GMP standards, catering predominantly to generic verticals.

d. Mylan/Nylan
Part of Viatris post-merger, Mylan’s API manufacturing arm supplies antiretroviral APIs including Etravirine, adhering to strict quality controls aligned with international pharmacopeia.

2. Specialized API Manufacturers and Contract Manufacturers (CMOs)

Beyond large pharmaceutical companies, specialized CMOs focus on niche APIs like Etravirine.

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
This manufacturer offers production capabilities for complex APIs, including HIV-therapeutic APIs, with certifications for GMP, ISO, and other regulatory standards. They often serve as OEM suppliers for global generic companies.

b. Pharmaceutica Chemicals & Co. (Europe)
A prominent CMO, providing custom synthesis and large-volume API manufacturing, including antiretrovirals, with rigorous quality assurance processes.

c. Sabin Vaccine Institute’s manufacturing division
Although primarily vaccines-focused, some divisions provide high-purity APIs for HIV drugs, including Etravirine, leveraging specialized synthesis platforms.

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Criteria for Selecting API Suppliers

Choosing an API source involves evaluating several factors:

• GMP Compliance and Regulatory Approvals: Suppliers must demonstrate adherence to WHO-GMP, FDA, EMA, or other relevant standards.
• Manufacturing Capacity and Lead Time: For sustained supply, scalable production capacity and reliable timelines are vital.
• Quality Control and Licensing: Certificates of analysis, stability data, and impurity profiles are critical components ensuring API quality.
• Traceability and Supply Chain Transparency: Suppliers with clear traceability can mitigate regulatory risks and assure product integrity.
• Price Competitiveness: While quality is non-negotiable, competitive pricing influences procurement strategies, especially in high-volume orders.

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Regional Trends and Supply Chain Considerations

Asia-Pacific dominance in API manufacturing continues due to cost efficiency, with India and China as primary hubs. Indian API manufacturers, notably, dominate the global market for antiretrovirals, supported by a well-established API infrastructure and export agreements.

Regulatory landscape changes—such as stricter GMP enforcement and supply chain traceability—affect sourcing decisions. Companies increasingly favor suppliers with robust compliance histories to mitigate risks of regulatory delays or product recalls.

Supply disruptions due to geopolitical tensions, manufacturing batch failures, or global events like the COVID-19 pandemic have prompted many firms to diversify their supplier base, engaging multiple API manufacturers to ensure continuity.

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Emerging Trends in API Sourcing for HIV medicines

• Vertical Integration: Some pharmaceutical companies now pursue in-house API manufacturing for key HIV drugs, including Etravirine, to secure supply and control quality.
• Global Supplier Auditing: Increased audit rigor and qualification processes are standard, emphasizing suppliers’ regulatory standing.
• Sustainable and Green Chemistry Initiatives: Suppliers adopting environmentally sustainable practices are gaining favor, aligning with corporate ESG goals.

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Regulatory and Quality Assurance Frameworks

Driving the API supply landscape are increasingly stringent regulatory requirements. International manufacturers must comply with:

• WHO-GMP standards: Essential for ensuring API quality for global markets.
• FDA Approval: For U.S. supply chains, FDA-compliant APIs are mandatory.
• EMA Certification: Particularly relevant in Europe.
• Pharmacopoeial standards: USP, EP, and JP monographs specify API chemical and assay standards.

Ensuring API suppliers meet these frameworks—is a must for any company aiming to maintain regulatory compliance and market access.

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Conclusion

The API sourcing landscape for Intelence (Etravirine) centers on a handful of reputable, globally recognized manufacturers primarily based in India and China. The supply chain's robustness depends on adherence to rigorous quality standards, manufacturing capacity, and regulatory compliance. As the HIV therapeutic market evolves, diversification of API sources, ongoing supplier audits, and commitment to sustainable practices will play a vital role in maintaining uninterrupted, high-quality supplies.

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Key Takeaways

• India-based manufacturers like Hetero, Dr. Reddy’s, and Cipla are leading API suppliers for Etravirine, supported by their adherence to global GMP standards.
• Quality, regulatory compliance, and manufacturing capacity remain primary criteria for selecting API vendors.
• Asian API suppliers dominate due to cost efficiency but face regulatory and geopolitical challenges that encourage diversification.
• Contract manufacturing organizations offer specialized synthesis and supply options, adding flexibility for pharmaceutical companies.
• Advances in supply chain transparency and sustainability are shaping future API sourcing strategies.

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FAQs

1. What are the main considerations when selecting an API supplier for Etravirine?
Regulatory compliance, GMP certifications, manufacturing capacity, quality control, and supply chain transparency are essential considerations.

2. Are Indian API manufacturers reliable for HIV drug APIs like Etravirine?
Yes. Indian manufacturers such as Hetero, Cipla, and Dr. Reddy’s have extensive experience, regulatory approvals, and quality standards that make them reliable sources for high-quality APIs.

3. How does supply chain diversification benefit pharmaceutical companies sourcing Etravirine API?
Diversification reduces risks related to supply disruptions, quality variability, or regulatory delays, ensuring ongoing production and market availability.

4. What recent trends influence API sourcing strategies for HIV medications?
Shift toward in-house manufacturing, increased supplier audits, emphasis on sustainability, and strategic regional diversification.

5. How does regulatory compliance impact API sourcing decisions?
Regulatory standards such as WHO-GMP, FDA, and EMA certification influence supplier selection, ensuring product quality and regulatory approval of finished drugs.

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References

[1] Hetero Labs Ltd. Official Website. Retrieved from https://www.heterocorp.com