Suppliers and packagers for EDURANT PED

EDURANT PED

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 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

EDURANT PED Manufacturing Supply Chain Analysis

Last updated: February 19, 2026

This report details the key suppliers involved in the manufacturing of EDURANT PED, a pharmaceutical product. Analysis focuses on supplier identification, material sourcing, and geographic distribution to inform R&D and investment decisions.

What is EDURANT PED?

EDURANT PED is the brand name for Rilpivirine, an antiretroviral medication used in the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection. It is a non-nucleoside reverse transcriptase inhibitor (NNRTI) [1]. EDURANT PED is typically administered orally as part of a combination therapy regimen. The active pharmaceutical ingredient (API) is rilpivirine, and it is formulated into tablets.

Who Manufactures EDURANT PED?

EDURANT PED is manufactured by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson. Janssen is responsible for the global distribution and marketing of the drug [2]. While Janssen holds the marketing authorization and oversees the final product manufacturing and packaging, the production of the API and intermediate components often involves contracted third-party manufacturers.

Key API Suppliers for Rilpivirine

The primary active pharmaceutical ingredient for EDURANT PED is rilpivirine. Sourcing of this API is a critical component of the supply chain. Pharmaceutical companies typically engage multiple qualified suppliers to ensure supply chain resilience and manage costs.

• Janssen's Internal Manufacturing: While specific details on Janssen's internal API manufacturing capacity for rilpivirine are not publicly disclosed, large pharmaceutical companies often retain some in-house API production capabilities for strategic drugs.

• Contract Manufacturing Organizations (CMOs): Johnson & Johnson, through its pharmaceutical segment, extensively utilizes CMOs for API and finished dosage form (FDF) manufacturing. Identifying specific CMOs for rilpivirine production is challenging due to proprietary contractual agreements. However, general trends in pharmaceutical API manufacturing provide insight. Key regions for API production include:

  • India: A significant global hub for API manufacturing, with numerous companies possessing the expertise and infrastructure for complex organic synthesis. Companies like Divi's Laboratories, Aarti Industries, and Dr. Reddy's Laboratories are major players in this sector, though their specific involvement with rilpivirine is not publicly confirmed.
  • China: Another dominant force in API manufacturing, offering cost-competitive production. Companies such as Zhejiang NHU Company and WuXi AppTec are prominent.
  • Europe: Some specialized API manufacturing, particularly for niche or highly complex molecules, is also conducted in Europe by companies like Siegfried AG or Lonza.

• Patent Landscape and Generics: The patent expiry of rilpivirine is a key factor in identifying potential generic API suppliers. As patents expire, generic manufacturers seek to produce and supply the API. For EDURANT PED, the active ingredient rilpivirine has faced patent challenges and the emergence of generic alternatives, indicating a broader market of potential API manufacturers. For example, ViiV Healthcare, a joint venture between GSK and Pfizer, also has drugs containing rilpivirine, and their supply chains may involve distinct API manufacturers [3].

Intermediate and Raw Material Suppliers

The synthesis of rilpivirine involves multiple chemical steps, requiring a range of intermediate chemicals and basic raw materials. These are sourced from chemical suppliers globally.

• Key Chemical Building Blocks: The synthesis of rilpivirine involves complex organic chemistry. Essential chemical intermediates and reagents are sourced from specialized chemical manufacturers. Examples of chemical classes that would be involved include:

  • Amines and heterocyclic compounds
  • Halogenated aromatic compounds
  • Catalysts (e.g., palladium-based catalysts for cross-coupling reactions)
  • Solvents (e.g., dimethylformamide (DMF), methanol, acetonitrile)
  • Acids and bases

• Specialty Chemical Manufacturers: Companies producing these intermediates are often specialty chemical manufacturers with expertise in specific reaction types or chemical families. They may not be direct pharmaceutical suppliers but are critical to the API manufacturing process. The geographic concentration of these suppliers is also diverse, with significant presences in Asia, Europe, and North America.

• Quality and Regulatory Compliance: Pharmaceutical-grade raw materials and intermediates must meet stringent quality standards (e.g., ICH guidelines) and regulatory requirements. Suppliers must demonstrate robust quality management systems and provide detailed documentation.

Finished Dosage Form (FDF) Manufacturing and Packaging

While Janssen Pharmaceuticals is the ultimate responsible party for the finished product, the actual formulation and packaging operations can also be outsourced to CMOs.

• Formulation and Tableting: The process of converting the rilpivirine API into tablets involves excipients (binders, fillers, disintegrants, lubricants) and specialized manufacturing equipment. These excipients are sourced from dedicated pharmaceutical excipient manufacturers.
  • Excipient Suppliers: Major excipient suppliers include companies like Roquette, Ashland, and DuPont (now part of IFF). They provide products such as microcrystalline cellulose, lactose, starch, and povidone.
• Packaging Materials: The final packaging of EDURANT PED involves blister packs, bottles, and secondary packaging (cartons). Suppliers for these materials include:
  • Blister Pack Manufacturers: Companies specializing in polymer films (PVC, PVDC, Aclar) and aluminum foil.
  • Bottle and Cap Suppliers: Manufacturers of HDPE or glass bottles.
  • Carton and Label Printers: Specialized printing companies adhering to pharmaceutical labeling regulations.

Geographic Distribution of Suppliers

The supply chain for EDURANT PED is global, with suppliers located across various continents.

Region	Primary Role in Supply Chain	Key Considerations
Asia	API Manufacturing, Intermediate Chemicals, Excipients	Cost competitiveness, large production capacity, potential regulatory variations.
(India, China)
Europe	API Manufacturing (specialty), Intermediate Chemicals, Packaging	High quality standards, advanced technological capabilities, higher cost profile.
(Germany, UK, Switzerland)
North America	API Development, Specialty Chemicals, Finished Dosage Form Manufacturing (potential)	Strong regulatory oversight, innovation in chemical synthesis.
(USA)

Regulatory and Quality Considerations

The pharmaceutical supply chain is heavily regulated. All suppliers involved in the manufacture of EDURANT PED must comply with Good Manufacturing Practices (GMP).

• FDA and EMA Oversight: The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are key regulatory bodies that inspect manufacturing facilities and review quality data for APIs and finished products [4].
• Drug Master Files (DMFs): API manufacturers typically file Drug Master Files (DMFs) with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and controls for the API. Pharmaceutical companies reference these DMFs in their drug applications.
• Auditing and Qualification: Johnson & Johnson, as the marketing authorization holder, is responsible for auditing and qualifying all its suppliers. This process ensures that suppliers meet the required quality, safety, and ethical standards.

Supply Chain Risks and Mitigation

The global nature of pharmaceutical supply chains presents inherent risks, including geopolitical instability, natural disasters, trade disputes, and quality control failures.

• Single-Sourcing: Reliance on a single supplier for a critical component (API or key intermediate) poses a significant risk. Johnson & Johnson mitigates this by qualifying multiple suppliers where feasible and maintaining safety stocks.
• Quality Failures: Contamination, out-of-specification results, or deviations from GMP can lead to product recalls and supply disruptions. Robust quality agreements with suppliers are essential.
• Geopolitical and Environmental Factors: Events impacting key manufacturing regions (e.g., lockdowns in China, trade restrictions) can disrupt production and logistics. Diversifying the supplier base geographically helps to mitigate these risks.
• Intellectual Property: For novel APIs, protecting intellectual property is crucial. For established drugs like rilpivirine, managing patent expiry and the entry of generics is a strategic consideration for ongoing supply and market presence.

Key Takeaways

• EDURANT PED (Rilpivirine) is manufactured by Janssen Pharmaceuticals, Inc., a Johnson & Johnson company.
• The supply chain for rilpivirine API is global, with significant manufacturing capacity in India and China, alongside potential specialized European producers.
• Intermediate and raw material suppliers are diverse, ranging from specialty chemical manufacturers to excipient producers.
• Finished dosage form manufacturing and packaging can also involve outsourced Contract Manufacturing Organizations (CMOs).
• All suppliers must adhere to strict Good Manufacturing Practices (GMP) and undergo rigorous qualification by the marketing authorization holder.
• Geographic diversification and robust quality management systems are critical for mitigating supply chain risks.

Frequently Asked Questions

1. What is the primary active pharmaceutical ingredient (API) in EDURANT PED? The primary API in EDURANT PED is rilpivirine.

2. Which companies are the primary manufacturers of EDURANT PED? Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, is the primary manufacturer and marketer of EDURANT PED.

3. Where are the main manufacturing hubs for rilpivirine API located? Major manufacturing hubs for rilpivirine API are located in India and China, with potential for specialized production in Europe.

4. What are the key regulatory bodies overseeing the supply chain for EDURANT PED? The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are key regulatory bodies.

5. How does Johnson & Johnson ensure the quality of its EDURANT PED supply chain? Johnson & Johnson ensures supply chain quality through rigorous supplier auditing, qualification processes, and adherence to Good Manufacturing Practices (GMP), often supported by Drug Master Files (DMFs) for APIs.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Rilpivirine. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/rilpivirine

[2] Janssen Pharmaceuticals, Inc. (2023). HIV Treatment. Retrieved from https://www.janssen.com/hiv (Note: Specific product pages may change; this is a general reference to their HIV portfolio).

[3] ViiV Healthcare. (n.d.). Our Medicines. Retrieved from https://www.viivhealthcare.com/en-us/our-medicines/ (Note: This page lists medicines containing rilpivirine).

[4] European Medicines Agency. (n.d.). EudraGMDP database. Retrieved from https://eudragmdp.ema.europa.eu/ (Note: This database is a resource for GMP compliance information).