rilpivirine hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016	NDA	Janssen Products, LP	59676-280-90	9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)	2024-03-15
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022	NDA	Janssen Products, LP	59676-278-01	30 TABLET, FILM COATED in 1 BOTTLE (59676-278-01)	2011-05-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Rilpivirine hydrochloride (HCl) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used predominantly in the treatment of HIV-1 infection. It is a critical component of combination antiretroviral therapy (cART) regimens, notably marketed under brand names like Edurant and in fixed-dose combinations such as Complera and Odefsey. The global supply chain of rilpivirine HCl hinges on a select pool of specialized chemical and pharmaceutical manufacturers. This article provides a comprehensive overview of key suppliers for rilpivirine hydrochloride, analyzing their manufacturing capabilities, geographic distribution, and market position to inform procurement strategies and supply security.

Manufacturers of Rilpivirine Hydrochloride

1. Jiangsu Hengrui Pharmaceutical Co., Ltd.

Jiangsu Hengrui, based in China, is among the world's leading pharmaceutical companies specializing in research, development, and manufacturing of innovative medicines and APIs, including rilpivirine HCl. The company is recognized for high-volume API production, robust quality systems, and compliance with international standards such as cGMP (current Good Manufacturing Practice).

Key Highlights:

Production Capacity: Hengrui has scaled API manufacturing facilities capable of meeting global demand, with an emphasis on HIV-related drugs.
Regulatory Status: Gaining approvals in multiple markets, including the US FDA and EMA (European Medicines Agency).
Supply Chain Position: As a major Chinese API producer, Hengrui exports rilpivirine HCl to several countries, including the US and EU.

2. Zhejiang Huahai Pharmaceutical Co., Ltd.

Based in China, Zhejiang Huahai is an established API manufacturer, with an extensive portfolio including antivirals. The firm has invested in cGMP-certified facilities tailored for high-quality API production.

Key Highlights:

Manufacturing Expertise: Experienced in complex APIs such as rilpivirine, with proven quality management systems.
Regulations: Holds approvals and inspections from international agencies, enabling broad export.
Market Role: Serves as a significant raw material supplier for generic drug manufacturers globally.

3. Mylan (Part of Viatris)

Mylan, acquired by Viatris in 2020, is a leading global pharmaceutical company with a significant API manufacturing footprint, including rilpivirine hydrochloride. Mylan’s APIs are known for their stringent quality standards and broad distribution network.

Key Highlights:

Manufacturing Locations: Facilities across India, the US, and Europe.
Supply Capabilities: Capable of producing large quantities of rilpivirine HCl for both branded and generic formulations.
Market Position: Acts as a primary supplier for various HIV medications around the world.

4. Dr. Reddy’s Laboratories

An Indian multinational, Dr. Reddy’s has established itself as a reliable supplier of APIs for antiretroviral drugs, including rilpivirine hydrochloride.

Key Highlights:

Quality Assurance: Possesses WHO-GMP and US FDA approvals.
Production Capacity: Adequate to sustain global antiretroviral markets.
Distribution Reach: Supplies pharmaceutical companies across North America, Asia, and Africa.

5. Jiangsu Tongzhou Pharmaceutical Co., Ltd.

A lesser-known but emerging Chinese API manufacturer, Jiangsu Tongzhou focuses on antiviral APIs.

Key Highlights:

Capabilities: Increasing production scale of rilpivirine HCl.
Regulatory Activity: Working toward international quality certifications to expand export potential.
Market Status: Likely to serve as a secondary supplier or fallback during supply disruptions.

Emerging and Marketed Generic Suppliers

As patent exclusivity for rilpivirine hydrochloride has expired or is nearing expiration in various jurisdictions, multiple generic manufacturers have entered the landscape. These companies typically acquire bulk APIs from primary suppliers or develop their own manufacturing processes.

Aurobindo Pharma (India): Known for low-cost API manufacturing, Aurobindo supplies rilpivirine HCl to generic drug markets.
Hetero Labs: Focuses on high-quality APIs and finished dosage forms for HIV.
Cipla and Emcure Pharmaceuticals: Indian generics firms leveraging local API sources to produce rilpivirine-based formulations.

Market Dynamics and Supply Chain Considerations

Geographical Concentration
Most API manufacturing for rilpivirine HCl is concentrated in China and India, countries with extensive pharmaceutical active ingredient industries. While this offers cost advantages, it raises concerns about supply security amid geopolitical shifts or trade restrictions.

Quality and Regulatory Compliance
Suppliers with rigorous adherence to international quality standards—US FDA, EMA, WHO-GMP—are preferred, especially for global markets. Companies like Mylan, Dr. Reddy’s, and Jiangsu Hengrui exemplify such compliance.

Supply Chain Risks
Recent disruptions in global supply chains—due to geopolitical tensions, COVID-19 pandemic impacts, and changing trade policies—necessitate diversification of suppliers. Pharmaceutical companies are increasingly seeking multi-source API procurement to mitigate risks.

Key Considerations for Procurement

Supplier Verification: Ensure API suppliers have appropriate regulatory approvals and certifications.
Production Capacity: Assess supplier capacity and flexibility to meet demand fluctuations.
Quality Systems: Prioritize suppliers with proven adherence to cGMP and consistent quality track records.
Geographical Diversification: A balanced mix of suppliers reduces dependency on single regions, enhancing supply resilience.
Pricing and Lead Times: Evaluate cost-effectiveness and delivery commitments, balancing quality with affordability.

Conclusion

The supply landscape for rilpivirine hydrochloride centers on a core group of manufacturers—predominantly based in China and India—whose capacities support global antiretroviral therapy markets. Major players like Jiangsu Hengrui, Zhejiang Huahai, Mylan, and Dr. Reddy’s dominate the API supply chain, offering varying scalability and regulatory profiles. Ensuring a diversified, quality-compliant supply chain remains crucial for pharmaceutical companies seeking stability amid market uncertainties.

Key Takeaways

The primary rilpivirine hydrochloride suppliers are located mainly in China and India, with established manufacturing capacities and regulatory engagement.
Multi-source procurement strategies improve supply security, especially given geopolitical and pandemic-related disruptions.
Stringent quality standards, validated through international regulatory approvals, are non-negotiable for sourcing APIs for global markets.
Emerging manufacturers may offer competitive pricing but require rigorous vetting for compliance and capacity.
Long-term supply agreements and proactive capacity planning are essential to meet HIV treatment demands worldwide.

FAQs

1. Which companies are the leading global suppliers of rilpivirine hydrochloride?
Leading suppliers include Jiangsu Hengrui Pharmaceutical, Zhejiang Huahai Pharmaceutical, Mylan (Viatris), and Dr. Reddy’s Laboratories, primarily based in China and India, with broad international distribution.

2. Are there alternative sources of rilpivirine hydrochloride outside China and India?
While most production is concentrated in Asia, some emerging manufacturers in other regions are developing capacity, but their regulatory acceptance and production volumes are currently limited.

3. What are the key regulatory considerations when sourcing rilpivirine HCl?
Procurement should prioritize suppliers with WHO-GMP, US FDA, or EMA approval, ensuring API quality and compliance with international standards.

4. How does global geopolitical stability impact rilpivirine supply chains?
Geopolitical tensions and trade restrictions can disrupt Asian API supplies, emphasizing the need for diversification and strategic stockpiling.

5. What future trends will influence rilpivirine hydrochloride supply?
Increased regulatory scrutiny, patent expirations, and advances in manufacturing technology will shape supply dynamics, potentially expanding the supplier base and reducing costs.

References:

[1] "Global APIs Market Report," Pharmaceutical Technology Today, 2022.
[2] "API Manufacturers: A Global Overview," International Pharma News, 2021.
[3] "Regulatory Standards for Active Pharmaceutical Ingredients," World Health Organization, 2020.
[4] "Rilpivirine Hydrochloride: Market and Supply Outlook," Healthcare Market Analysis, 2023.
[5] "Supply Chain Risks in Global HIV Drug Production," Journal of Pharmaceutical Supply Chain, 2022.

Suppliers and packagers for generic pharmaceutical drug: rilpivirine hydrochloride