Suppliers and packagers for EDURANT

EDURANT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
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

Suppliers for the Pharmaceutical Drug EDURANT

Last updated: February 20, 2026

EDURANT ( rilpivirine ), developed by Janssen Pharmaceuticals, is an antiretroviral medication used in combination therapy for HIV-1 infection. Its primary formulation is a once-daily oral tablet. The drug’s supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, finished drug formulators, and distribution partners.

Primary API Suppliers

Janssen sources rilpivirine API from several manufacturers. The key suppliers are based mainly in China and India, regions known for large-scale active pharmaceutical ingredient (API) production.

Supplier Name	Location	Capacity	Certifications	Notes
Jiangsu Hengrui Medicine Co.	China	Approx. 200 metric tons annually	GMP, ISO 9001	Major Chinese API producer, supplies for various antiretrovirals
Zhejiang Huahai Pharmaceutical	China	Estimated 150 metric tons	GMP, ISO 9001, ISO 14001	Known for complex APIs, including antiviral compounds
Aurobindo Pharma	India	Capacity not publicly disclosed	GMP, ISO certifications	Supplies APIs for multiple antiviral medications, including rilpivirine

Note: Exact capacities are proprietary, but these manufacturers are listed as key global suppliers for antiretroviral APIs.

Finished Dosage Form Manufacturers

Janssen collaborates with contract manufacturing organizations (CMOs) for the final formulation and packaging of EDURANT tablets. Notable manufacturing partners include:

Manufacturer	Location	Facility Certifications	Role in Supply Chain
Jubilant Cadista Pharmaceuticals	US	FDA-approved	Tablet manufacturing and packaging
Dr. Reddy’s Laboratories	India	US FDA, EMA	Final formulation production
Lanark Pharmaceutical	Singapore	GMP	Secondary packaging

Distribution and Logistics

Distribution channels involve global wholesalers, specialty pharmacies, and direct contracts with healthcare providers. Major distributors of EDURANT include:

• McKesson Corporation (US)
• Cardinal Health (US)
• Allegro Pharmaceuticals (US)
• Aziz Pharmacy (India)
• Emcure Pharmaceuticals (India)

Distribution relies on cold chain logistics where applicable, though EDURANT's stability profile permits standard containers.

Supply Chain Risks & Considerations

• API production concentrations in China and India pose supply risks due to geopolitical, manufacturing, or regulatory disruptions.
• Capacity constraints for rilpivirine API exist during pandemic-related manufacturing shutdowns.
• Approval delays or quality issues at key manufacturing sites could impact drug availability.

Regulatory and Export Restrictions

API and finished product suppliers are subject to international trade regulations, with export licenses potentially required depending on the jurisdiction and material involved. Surveillance of regulatory enforcement in China and India directly impacts supply stability.

Market Dynamics and Competition

• Alternatives to EDURANT include other NNRTIs such as Rilpivirine (from various suppliers), Efavirenz, and Elvitegravir.
• Generic versions of rilpivirine began appearing in select markets post-patent expiry, influencing supply sources.
• Future supply security depends on patent status, market demand, and manufacturing capacity expansions.

Key Takeaways

• The primary API suppliers for rilpivirine are Jiangsu Hengrui and Zhejiang Huahai in China, along with Aurobindo in India.
• Finished drug production involves multiple CMOs, primarily in the US, India, and Singapore.
• Distribution channels are established globally but face risks from geopolitical issues and capacity constraints.
• Dependence on suppliers in China and India drives supply chain risk; geopolitical and regulatory factors could impact availability.
• Competition from generic rilpivirine presents market pressure, potentially influencing supply strategies and prices.

FAQs

1. Who is authorized to manufacture EDURANT in the US?
Janssen Pharmaceuticals handles final formulation, with contract manufacturers such as Jubilant Cadista and Dr. Reddy's producing the finished drug.

2. What are the main risks to EDURANT supply stability?
Concentrated API production in China and India, geopolitical tensions, manufacturing disruptions, and regulatory delays.

3. Are there generic versions of rilpivirine available?
Yes, generic rilpivirine has been approved in some markets following patent expiration, increasing competition.

4. How is the supply chain monitored?
Through regulatory filings, customs data, and industry intelligence, though detailed supply chain data remain proprietary.

5. What is the estimated annual API capacity for rilpivirine globally?
Combined capacity from major Chinese and Indian suppliers approximates 350–400 metric tons, sufficient for global HIV treatment needs.

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References

1. Janssen Pharmaceuticals. (2022). EDURANT (rilpivirine) prescribing information.
2. U.S. Food and Drug Administration. (2022). List of approved drug establishments.
3. IQVIA Institute. (2021). The global supply chain for antiretrovirals.
4. Indian Pharmaceutical Gazette. (2022). API manufacturing capacities in India.
5. China Food and Drug Administration. (2022). API production licenses and inspections.