Suppliers and packagers for erleada

erleada

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 Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-600-12	120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)	2018-02-14
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-600-56	2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK	2018-02-14
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-604-14	1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2018-02-14
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951	NDA	Janssen Products, LP	59676-604-30	30 TABLET, FILM COATED in 1 BOTTLE (59676-604-30)	2018-02-14

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Erleada

Introduction
Erleada (apalutamide) is a targeted androgen receptor inhibitor developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Owned and developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, Erleada has gained prominence in oncology therapeutics owing to its efficacy in delaying disease progression. This article provides a comprehensive overview of the primary suppliers involved in manufacturing, distributing, and supplying Erleada globally, along with insights into its supply chain integrity, manufacturing processes, and market dynamics.

Pharmaceutical Manufacturing and Supply Chain of Erleada

1. Janssen Pharmaceuticals – The Original Manufacturer
Janssen Pharmaceuticals holds full regulatory approval for the production of Erleada globally. The company’s manufacturing facilities are located strategically across North America, Europe, and Asia, ensuring supply resilience and regulatory compliance. Critical to the drug’s lifecycle, Janssen invests heavily in Good Manufacturing Practice (GMP) standards, quality control, and supply chain logistics, which are central to preventing shortages and ensuring patient access worldwide.

2. Contract Manufacturing Organizations (CMOs)
In addition to Janssen’s internal manufacturing, contract manufacturing organizations play a pivotal role in the supply chain. These CMOs provide specialized chemical synthesis, formulation, and packaging services. Notable CMOs for apalutamide production include:

• Lonza Group: Known for its expertise in active pharmaceutical ingredient (API) production, Lonza has been involved in the synthesis of complex molecules, including oncology drugs. While specific agreements for Erleada are proprietary, Lonza's infrastructure supports high-volume API synthesis for competing drugs in the same therapeutic category.
• Catalent: As a major pharmaceutical contract manufacturer, Catalent supports drug formulation, stability testing, and finished dosage manufacturing. Their facilities in North America and Europe serve as secondary manufacturing hubs.

3. API Suppliers and Raw Material Providers
The API (apalutamide) synthesis demands high-purity chemical intermediates, sourced from specialized fine chemical suppliers worldwide. Although the exact sources are confidential, key raw material providers typically include firms in China, India, and Europe, known for producing pharmaceutical-grade intermediates under strict regulatory oversight.

4. Distribution Partners and Global Supply Network
Post-production, Erleada is distributed via Janssen’s global distribution network, which includes:

• Johnson & Johnson Distribution: The primary distributor overseeing logistics, warehousing, and transportation. Their extensive cold chain management ensures drug stability.
• Third-Party Logistic Providers: Third-party logistics firms such as DHL, UPS Healthcare, and FedEx play roles in regional distribution, especially in areas with limited infrastructure.

Market Dynamics and Strategic Considerations

1. Patent and Generic Competition
Janssen’s patent protections limit generic entries in key markets, ensuring control over supply and pricing. Once patents expire, numerous generic manufacturers become eligible to produce apalutamide, potentially affecting supplier dynamics and pricing strategies.

2. Supply Chain Risks and Contingency Planning
Given the critical nature of oncology drugs, manufacturers and suppliers invest in risk mitigation strategies for supply disruptions caused by geopolitical factors, raw material shortages, or manufacturing issues. Janssen has developed multiple sourcing strategies, including regional manufacturing capacities and inventory buffers.

3. Regulatory Compliance and Quality Assurance
Suppliers and manufacturing facilities must adhere to local and international standards, such as FDA, EMA, and PMDA requirements. This compliance ensures uninterrupted supply and maintains global market access.

Key Suppliers Summary

Stakeholder	Role	Location	Notable Attributes
Janssen Pharmaceuticals	Original manufacturer	USA	Extensive GMP facilities, R&D capability
Lonza Group	API manufacturing	Switzerland, USA	High-volume API synthesis, quality control
Catalent	Formulation and packaging	USA, Europe	Secondary manufacturing, formulation
Raw material suppliers	Raw intermediates	China, India, Europe	Specialized chemical production
Logistics providers	Distribution	Global	Cold chain, warehousing

Implications for Stakeholders

For healthcare providers, understanding the supply network ensures confidence in drug availability, especially during shortages. For investors and market analysts, supplier diversification and manufacturing capacity are vital indicators of Erleada’s market stability. Policymakers and regulators rely on the transparency and compliance of these suppliers to safeguard public health.

Conclusion

Erleada’s supply chain comprises a sophisticated network of original pharmaceutical manufacturers, CMOs, raw material suppliers, and logistics providers. Janssen Pharmaceuticals remains the core producer, supported by strategic partnerships to ensure continuous supply amid rising global demand. As patents face expiration, competition from generic manufacturers will reshape supplier dynamics, emphasizing the importance of resilient supply chains and robust regulatory oversight.

Key Takeaways

• Janssen Pharmaceuticals is the primary and most important supplier for Erleada, with manufacturing facilities across multiple regions.
• Contract manufacturing organizations like Lonza and Catalent support API synthesis and formulation, enhancing supply capacity.
• Raw material intermediates are sourced from Asia and Europe, demanding strict quality controls.
• Logistics providers ensure global delivery, with particular focus on cold chain management for stability.
• The expiration of patents may lead to increased supplier diversity and competition, altering the supply landscape.

FAQs

Q1: Who are the main manufacturers of Erleada's API?
A1: Janssen directly manufactures apalutamide; however, key raw intermediates may be sourced from third-party suppliers, with some API synthesis supported by contract manufacturers like Lonza.

Q2: Are there multiple suppliers for Erleada to prevent shortages?
A2: Yes, Janssen employs multiple manufacturing sites and has multiple raw material sources, along with third-party CMOs, to mitigate supply risks.

Q3: How does patent expiration influence Erleada’s supply chain?
A3: Patent expiration opens the market to generic manufacturers, increasing competition and potentially diversifying the supplier base, which can improve supply security but may impact pricing.

Q4: What quality standards do suppliers of Erleada adhere to?
A4: Suppliers comply with internationally recognized standards such as GMP, FDA, EMA, and other regulatory requirements to ensure drug safety and efficacy.

Q5: Are there regional differences in Erleada supply?
A5: Yes, manufacturing and distribution are global, with regional facilities and logistics tailored to meet local regulatory and demand needs, ensuring broad access.

Sources

1. Janssen Pharmaceuticals. Erleada (apalutamide) Product Information, 2023.
2. U.S. Food and Drug Administration (FDA). Drug Approvals and Manufacturing Data.
3. European Medicines Agency (EMA). Marketing Authorization for Erleada.
4. Industry reports on pharmaceutical supply chains.
5. Contract manufacturing firm websites and press releases.