Bulk Pharmaceutical API Sources for PIFELTRO

Bulk Pharmaceutical API Sources for PIFELTRO

Vendor	Vendor Homepage	Vendor Sku	API Url
Alsachim		4668
Sun-shine Chemical		Doravirine
A2Z Chemical		AZB35680
MedChemexpress MCE		HY-16767
AbaChemScene		CS-5924

Bulk Active Pharmaceutical Ingredient (API) Sources for PIFELTRO

Last updated: July 30, 2025

Introduction

PIFELTRO (Pifeltro) is a pharmaceutical formulation that contains the active pharmaceutical ingredient (API) doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the management of HIV-1 infection. As a critical component of antiretroviral therapy (ART), the quality, availability, and sourcing of doravirine API directly influence global access, manufacturing consistency, and cost-effectiveness for PIFELTRO production. This article provides a comprehensive overview of the global API sourcing landscape for doravirine, highlighting key manufacturers, sourcing considerations, regulatory implications, and market trends.

Overview of Doravirine API

Developed by Merck & Co., doravirine (brand name PIFELTRO) was approved by the U.S. Food and Drug Administration (FDA) in 2018. Its synthesis involves complex organic pathways emphasizing safety, potency, and low toxicity. The quality of the API determines the efficacy and safety of the final pharmaceutical product. Therefore, identifying reliable bulk API sources is crucial for pharmaceutical companies seeking to manufacture or supply PIFELTRO consistently.

Major Api Manufacturers for Pifeltro

1. Merck & Co. — Original Innovator Supplier

As the patent holder and original developer of doravirine, Merck is the primary supplier of the API for initial formulations and proprietary use. Merck maintains strict control over API quality, supply chains, and regulatory compliance, ensuring consistent pharmaceutical-grade API.

Advantages:

• Guaranteed API purity and quality.
• Established regulatory approval processes.
• Robust manufacturing infrastructure.

Limitations:

• Pricing power due to patent protections.
• Limited flexibility in supplying emerging markets or generic manufacturing.

2. Contract Manufacturing Organizations (CMOs)

Following patent expiry or through licenses, several CMOs have entered the market to produce doravirine API under licensing agreements or for generic drug manufacturers.

• Hetero Laboratories Ltd. (India): A prominent CMO with experience in HIV API synthesis, including NNRTIs. Hetero has invested in scalable production of doravirine, adhering to current Good Manufacturing Practices (cGMP).

• Rusan Pharma (India): Known for producing various antiretroviral APIs, including NNRTIs, Rusan supplies bulk doravirine API to manufacturers globally.

• Mylan (now part of Viatris): Historically engaged in generic antiretroviral API manufacturing, likely to expand supply for doravirine following patent limitations.

Advantages with CMOs:

• Cost-effective production.
• Increased capacity for supply to meet global demand.
• Regional manufacturing reduces logistics costs.

Challenges:

• Ensuring API quality meets regulatory standards.
• Possible delays in scale-up or process validation.

3. Emerging API Suppliers and Regional Players

As demand for affordable HIV treatment rises, regional suppliers in China and India are expanding API manufacturing capabilities.

• Zhejiang Huayou Cobalt Co. (China): Recently developing APIs related to HIV treatment, including NNRTIs, bolstering regional supply options.

• Cipla (India): A leading generics manufacturer with a history of producing antiretrovirals for global markets, potentially involved in API synthesis for doravirine.

Market Trends:

• Increasing API manufacturing capacity in India and China.
• Growing industry focus on strict compliance with WHO-GMP standards.
• Development of high-volume, cost-competitive APIs to support global HIV programs.

Regulatory Considerations for API Sourcing

Manufacturers sourcing doravirine API must ensure compliance with stringent quality standards mandated by regulatory agencies such as the FDA, EMA, and WHO. Regulatory approvals often require detailed documentation on manufacturing processes, validation, impurity profiles, and stability data.

• Good Manufacturing Practices (GMP): Essential for APIs intended for direct pharmaceutical use.
• Batch-to-Batch Consistency: Critical for clinical safety.
• Documentation and Traceability: Suppliers must provide comprehensive dossiers for regulatory registration.

In many regions, APIs sourced from WHO-prequalified suppliers or those with accreditation from authorities such as the USFDA or EMA are preferred to facilitate seamless regulatory approval.

Market Dynamics and Future Outlook

The evolution of COVID-19 and HIV treatment strategies influences API sourcing strategies:

• Patent Expiry and Generics: The patent for doravirine is expected to expire in the coming years, opening the market for multiple generic manufacturers and API suppliers.

• Global Access Initiatives: WHO and UNAIDS promote the use of affordable, quality-assured APIs to eradicate HIV/AIDS, encouraging partnerships with API manufacturers in emerging economies.

• Supply Chain Resilience: Recent disruptions have prompted manufacturers to diversify API sourcing to reduce reliance on single suppliers, emphasizing regional and local manufacturing.

• Technological Innovations: Advances in synthetic chemistry reduce costs and streamline API synthesis, enabling increased production capacity and quality.

Conclusion

The API sourcing landscape for PIFELTRO's active ingredient, doravirine, is characterized by a mix of originator supply, licensed CMOs, and emerging regional manufacturers. While Merck remains the primary source, the expiration of patents and industry developments are fostering a more diverse, competitive API market. Ensuring high-quality API supply through stringent regulatory adherence and diversified sourcing strategies remains essential for continuous, cost-effective production of PIFELTRO.

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Key Takeaways

• Merck is the principal original API manufacturer, guaranteeing high quality but with limited flexibility due to patent protections.
• Several Indian and Chinese CMOs are emerging as significant API suppliers, offering cost-saving solutions for global markets.
• Regulatory compliance, quality assurance, and traceability are vital for API sourcing, especially in highly regulated markets.
• Patent expirations and global demand for affordable HIV treatment are driving increased API manufacturing capacity and competition.
• Diversifying API supply sources can bolster supply chain resilience and reduce manufacturing risks.

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FAQs

1. Who are the top API manufacturers for doravirine globally?
Key manufacturers include Merck & Co. as the original innovator, with major licensed CMOs such as Hetero Laboratories and Rusan Pharma in India, alongside emerging players in China and other regions.

2. What should companies consider when sourcing doravirine API?
Regulatory compliance (GMP), purity and impurity profiles, traceability, manufacturing capacity, and cost are critical factors influencing sourcing decisions.

3. How does patent expiry impact API sourcing for PIFELTRO?
Patent expiry enables multiple generic manufacturers to produce doravirine API, increasing competition, reducing costs, and improving global access to affordable HIV medications.

4. Are there any concerns regarding API quality from emerging suppliers?
Yes, organizations must rigorously evaluate emerging suppliers' compliance with international standards, including GMP certification, quality control processes, and batch consistency, before procurement.

5. How does global demand influence API production capacity for doravirine?
Growing demand for affordable HIV treatment prompts manufacturers to expand capacity, invest in new synthetic processes, and establish regional manufacturing hubs to ensure reliable API supply.

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Sources

[1] U.S. Food and Drug Administration. Pifeltro (doravirine) product approval details. FDA Databases, 2018.
[2] Merck & Co. Official product information for PIFELTRO.
[3] WHO Prequalification Programme reports on antiretroviral APIs.
[4] Industry reports on global API manufacturing capacities and trends.
[5] Market analyses on patent expiries and generic antiretroviral drugs.