dolutegravir sodium; rilpivirine hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192	NDA	ViiV Healthcare Company	49702-242-13	30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)	2017-11-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The global demand for antiretroviral therapies (ART) continues to grow in response to the HIV/AIDS epidemic. Central to this therapeutic landscape are key active pharmaceutical ingredients (APIs), notably Dolutegravir Sodium and Rilpivirine Hydrochloride. Securing suppliers for these compounds is essential for pharmaceutical companies, generic manufacturers, and health authorities aiming to ensure consistent supply, affordability, and accessibility of HIV treatments.

This report provides a comprehensive overview of the primary suppliers for Dolutegravir Sodium and Rilpivirine Hydrochloride, including manufacturing landscapes, key players, geographic distribution, and recent market trends.

1. Overview of Dolutegravir Sodium and Rilpivirine Hydrochloride

Dolutegravir Sodium is an integrase strand transfer inhibitor (INSTI), one of the most potent antiretroviral agents, characterized by high efficacy and tolerability. It forms a core component of first-line HIV therapies globally, including fixed-dose combinations.

Rilpivirine Hydrochloride is a non-nucleoside reverse transcriptase inhibitor (NNRTI), used predominantly in combination regimens. Its long half-life and minimal drug interactions make it favorable for specific patient populations.

Both APIs are classified as essential medicines by the World Health Organization (WHO) and are under strict regulatory frameworks.

2. Major API Suppliers for Dolutegravir Sodium

2.1. Global Market Leaders

Hetero Labs (India): A pioneer in API manufacturing, Hetero produces Dolutegravir intermediates and APIs. Its facilities are GMP-compliant and cater to both generic and branded drug markets.[1]
Mylan (Viatris): A significant supplier through its manufacturing units in India, Mylan (now part of Viatris) supplies Dolutegravir for global markets, especially in low- and middle-income countries (LMICs).[2]
Aurobindo Pharma: An Indian pharmaceutical titan with extensive API production capabilities for Dolutegravir, adhering to stringent quality standards.[3]
Genix Pharma: Based in Pakistan, Genix has increased its API production capacity for Dolutegravir, serving regional and international markets.[4]
Zhejiang Huahai Pharmaceuticals (China): Engaged in the production of various antiretroviral APIs, including Dolutegravir intermediates.[5]

2.2. Key Asia-Pacific API Manufacturers

Ascend Laboratories (India): Known for high-quality manufacturing and competitive pricing, Ascend supplies Dolutegravir to several global generic markets.[6]
Cipla (India): As a major branded and generic drug manufacturer, Cipla produces Dolutegravir in various formulations and APIs for worldwide distribution.[7]

2.3. Regulatory and Market Dynamics

Indian and Chinese pharmaceutical companies dominate the supply of Dolutegravir APIs, leveraging lower manufacturing costs and expanding global outreach.[8] Recently, the inclusion of Dolutegravir in WHO’s prequalification list enhances market access for compliant manufacturers.[9]

3. Major API Suppliers for Rilpivirine Hydrochloride

3.1. Prominent Manufacturers

Jubilant Life Sciences (India): A key player offering Rilpivirine API, with a robust track record of compliance with international standards. Jubilant supplies to global generic companies and major pharmaceutical firms.[10]
Hetero Labs: Beyond Dolutegravir, Hetero manufactures Rilpivirine API for global markets, emphasizing quality control.[11]
Cipla: Besides its formulation expertise, Cipla is involved in Rilpivirine API production, providing competitively priced interventions.[12]
Thermo Fisher Scientific (now part of GSK): Although primarily a contract manufacturer, Thermo Fisher supplies Rilpivirine raw materials to qualified partners.[13]
Dr. Reddy's Laboratories: As an emerging API producer, Dr. Reddy's supplies Rilpivirine to regional markets, with ongoing capacity expansion.[14]

3.2. Chinese and Southeast Asian Market

Chinese API manufacturers, like Zhejiang Hisun Pharmaceutical and Zhejiang Yuhong Pharmaceutical, have increased Rilpivirine API production, driven by rising demand from generics manufacturers.[15]

3.3. Strategic Considerations

While Indian companies dominate Rilpivirine API supply, regulatory compliance and API source traceability have become critical, prompting many companies to seek WHO-prequalified or U.S. FDA-approved sources.[16]

4. Key Factors Influencing Supplier Selection

Regulatory Compliance & Quality Assurance: Manufacturers must meet international standards such as GMP, WHO Prequalification, and FDA approval, especially for APIs destined for LMIC markets and procurement agencies.[17]
Cost & Capacity: Indian and Chinese API producers exhibit competitive pricing and scalable capacity, making them favorable suppliers in the current market landscape.[18]
Supply Chain Reliability: Long-term relationships, transparent quality records, and adherence to delivery schedules are crucial for supply chain stability.
Intellectual Property & Licensing: While Dolutegravir and Rilpivirine APIs are often manufactured under generic frameworks, licensors and patent holders may influence sourcing decisions in specific markets.[19]

5. Market Trends & Future Outlook

The market for Dulutegravir and Rilpivirine APIs is expected to grow amid increasing global access programs and dosing approvals in new regions. The trend toward local manufacturing, especially in Africa and South America, is driving investments in API capacity expansion.

Key developments include:

Increased WHO prequalification of API producers, broadening access for procurement agencies.
Technological advancements in synthesis processes improving yield, purity, and cost-efficiency.
Regulatory harmonization efforts that streamline approvals and facilitate cross-border supply chains.
Strategic partnerships and licensing agreements to bolster API supply chain resilience.

6. Conclusion: Navigating the API Supplier Landscape

The global supply chain for Dulutegravir Sodium and Rilpivirine Hydrochloride remains predominantly driven by Indian and Chinese manufacturers. Leading companies like Hetero Labs, Mylan/Viatris, Cipla, Jubilant, and Aurobindo have established reliable, quality-focused operations serving both branded and generic markets.

Business stakeholders should prioritize suppliers with WHO prequalification or GMP compliance, scalable capacity, and proven delivery reliability. Additionally, ongoing geopolitical considerations, regulatory developments, and technological innovation are critical factors shaping sourcing strategies.

Key Takeaways

Indian and Chinese manufacturers dominate the API supply landscape for Dolutegravir and Rilpivirine, offering competitive pricing and extensive capacity.
Regulatory compliance, including WHO PQ and FDA approval, remains a top criterion for supplier qualification.
The evolving market demands, driven by global HIV treatment initiatives, create opportunities for expansion and diversification in the API supply chain.
Strategic partnerships, quality assurance, and supply chain resilience are key to maintaining uninterrupted access to critical antiretroviral APIs.
Manufacturers investing in technological enhancements and quality certifications will be better positioned to capitalize on market growth.

FAQs

Q1: Who are the leading global suppliers for Dolutegravir Sodium?
Indian pharmaceutical companies such as Hetero Labs, Mylan (Viatris), Aurobindo Pharma, and Cipla dominate the market, providing high-quality Dolutegravir APIs for worldwide distribution.

Q2: Are Chinese manufacturers significant players in Rilpivirine Hydrochloride supply?
Yes, Chinese firms like Zhejiang Hisun Pharmaceutical and Zhejiang Yuhong Pharmaceutical have increased production, targeting regional and international markets with competitive offerings.

Q3: What quality standards should suppliers for these APIs meet?
Suppliers should adhere to GMP, WHO prequalification, FDA Good Manufacturing Practices, or equivalent standards to ensure safety, efficacy, and regulatory acceptance.

Q4: How do market trends impact API sourcing strategies?
Growing demand and technological innovations drive manufacturers to expand capacity and improve quality. Buyers should prioritize suppliers aligned with global health regulations and capable of scaling production.

Q5: What role does the WHO prequalification process play in API procurement?
WHO prequalification enhances supplier credibility, facilitates procurement in LMICs, and ensures compliance with international quality standards, thus influencing sourcing decisions.

References

End of Report

Suppliers and packagers for generic pharmaceutical drug: dolutegravir sodium; rilpivirine hydrochloride