abiraterone acetate; niraparib tosylate: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793	NDA	Janssen Biotech, Inc.	57894-050-60	1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2023-08-11
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793	NDA	Janssen Biotech, Inc.	57894-100-60	1 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2023-08-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for oncology treatments continues to evolve with the development of targeted therapies such as Abiraterone Acetate and Niraparib Tosylate. These agents play critical roles in managing prostate and ovarian cancers, respectively. Securing reliable suppliers for these compounds is essential for pharmaceutical manufacturers, distributors, and healthcare providers to ensure consistent, high-quality supply chains. This article provides a comprehensive overview of the key suppliers for Abiraterone Acetate and Niraparib Tosylate, including manufacturers, geographic distribution, regulatory status, and strategic considerations.

Overview of Abiraterone Acetate and Niraparib Tosylate

Abiraterone Acetate is an orally administered androgen biosynthesis inhibitor predominantly used in treating metastatic castration-resistant prostate cancer (mCRPC). It was developed by Janssen Pharmaceuticals and approved by the FDA in 2011[1]. Its mechanism involves inhibiting CYP17A1, a critical enzyme in androgen biosynthesis, thereby suppressing testosterone production.

Niraparib Tosylate is a PARP (poly ADP-ribose polymerase) inhibitor used primarily to treat ovarian cancer, particularly in patients with BRCA mutations. It was developed by GlaxoSmithKline and received FDA approval in 2017[2]. Niraparib’s efficacy stems from synthetic lethality in cancer cells deficient in homologous recombination repair mechanisms.

Major Manufacturers and Suppliers

Abiraterone Acetate

Janssen Pharmaceuticals: As the originator, Janssen is the primary supplier globally. The company produces Abiraterone Under the brand name Zytiga and supplies it directly through its manufacturing facilities in the U.S., Europe, and Asia.
Contract Manufacturing Organizations (CMOs): Several CMOs manufacture Abiraterone Acetate under licensing agreements or for Janssen, including:
- Patheon (Thermo Fisher Scientific): Known for high-quality active pharmaceutical ingredient (API) manufacturing.
- FAM (Famar): A European contract manufacturer involved in large-scale APIs.
Generic Manufacturers: Post-patent expiration in many regions, numerous generic producers have entered the market, notably:
- Macleods Pharmaceuticals: India-based, supplying Abiraterone Generics.
- Sun Pharmaceutical Industries: Also based in India, manufacturing Abiraterone in various forms.
- Teva Pharmaceutical Industries: Global generic provider with Abiraterone products.
Regulatory Approvals: Regardless of manufacturer, all suppliers must meet stringent regulations by agencies such as FDA (U.S.), EMA (Europe), and PMDA (Japan).

Niraparib Tosylate

GlaxoSmithKline (GSK): As the originator, GSK is the main supplier of Niraparib, branded as Zejula globally. GSK maintains integrated manufacturing facilities in the UK and manufacturing partnerships in Asia.
CMOs and Licensed Manufacturers:
- Several CMOs collaborate with GSK to produce APIs and finished formulations, often in India and China, leveraging cost efficiencies and capacity.
Generic Manufacturers: Since patent expiry, multiple generic producers have entered the market:
- Mylan (now part of Viatris): Known for generic oncology APIs.
- Dr. Reddy’s Laboratories: India-based, producing Niraparib generics.
- Cipla: Also an Indian pharmaceutical firm producing Niraparib.
Regulatory Considerations: Suppliers are required to meet rigorous standards set by authorities such as the FDA, EMA, and local regulatory bodies.

Geographic Distribution of Suppliers

The global supply chain for both drugs comprises key manufacturing hubs primarily located in North America, Europe, and Asia, significant for their volume, cost efficiencies, and regulatory rigor:

North America: The U.S. remains the primary market with Janssen’s manufacturing facilities, supplemented by domestic generic manufacturers.
Europe: Several manufacturing units, especially in countries like Germany and Ireland, supply both brand-name and generic versions.
Asia: India and China serve as critical hubs for generic manufacturing and API production. Indian companies like Sun Pharma, Dr. Reddy’s, and Cipla dominate the generic API and finished dosages for global markets.

Regulatory and Quality Considerations

Suppliers are subject to strict regulatory oversight. For originator products, compliance with FDA, EMA, and other authority standards is non-negotiable. Generic manufacturers must demonstrate bioequivalence and quality compliance before market authorization.

Quality control measures include:

Good Manufacturing Practices (GMP): Ensured by regulatory bodies.
Third-party audits and inspections.
Robust stability and bioequivalence testing.

Reliability and quality assurance are key for maintaining supply security, particularly for oncology drugs with narrow therapeutic windows.

Strategic Sourcing and Supply Chain Risks

Pharmaceutical companies pursue a diversified supplier base to mitigate risks associated with:

Manufacturing disruptions due to regulatory actions or capacity constraints.
Raw material shortages.
Regulatory non-compliance.

Strategic partnerships with multiple manufacturers, including both originators and approved generics, enhance supply chain resilience.

Future Outlook and Supply Chain Trends

Increased Source Diversification: As patents expire, the shift toward multiple generic suppliers reduces reliance on single-source providers.
Biopharmaceutical and Biosimilar Competition: Additional entrants may influence pricing and availability.
Regulatory Harmonization: International cooperation streamlines approval processes, expanding manufacturing capacities.
Technological Advances: Enhanced manufacturing techniques, such as continuous flow synthesis, improve scalability and quality control.

Key Takeaways

Leading suppliers for Abiraterone Acetate include Janssen Pharmaceuticals, with numerous licensed generics from India and China. Ensuring regulatory compliance and quality is paramount.
Niraparib Tosylate is primarily supplied by GSK, with a growing network of licensed generics from Indian and Chinese manufacturers.
Geographic diversification of suppliers mitigates risks associated with regional disruptions and enhances supply chain resilience.
Regulatory compliance remains a fundamental criterion for suppliers, with GMP standards and quality assurance programs central to operations.
The generic market segment is expanding swiftly, driven by patent expirations and increased demand for affordable oncology drugs worldwide.

FAQs

Who are the leading global suppliers of Abiraterone Acetate?
Janssen Pharmaceuticals is the primary originator, supplemented by licensed generic manufacturers such as Macleods and Sun Pharma.
Are there reliable generic alternatives to branded Niraparib?
Yes. Multiple Indian and Chinese pharmaceutical companies produce generic Niraparib, approved in various markets, ensuring accessibility and cost-effectiveness.
What risks exist in sourcing these drugs?
Risks include manufacturing delays, quality deficiencies, regulatory non-compliance, and raw material shortages. Diversification of suppliers helps mitigate these risks.
How does patent expiration affect the supply chain?
Patent expiry broadens the supplier base, increasing competition, reducing costs, and enhancing supply security through generic manufacturing.
What regulatory considerations should be addressed in supplier selection?
Vendors must adhere to GMP standards, possess necessary approvals (FDA, EMA, etc.), and demonstrate consistent quality control to ensure drug safety and efficacy.

References

[1] U.S. Food and Drug Administration. ZYTIGA (Abiraterone Acetate) Prescribing Information. 2011.

[2] U.S. Food and Drug Administration. Niraparib (Zejula) Approval Announcement. 2017.

Suppliers and packagers for generic pharmaceutical drug: abiraterone acetate; niraparib tosylate