Suppliers and packagers for ZYTIGA

ZYTIGA

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	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379	NDA	Janssen Biotech, Inc.	57894-150-12	120 TABLET in 1 BOTTLE (57894-150-12)	2011-04-28
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379	NDA	Janssen Biotech, Inc.	57894-195-06	60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)	2017-04-17
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379	NDA	Janssen Biotech, Inc.	57894-195-15	60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)	2017-04-17

Suppliers for the Pharmaceutical Drug: ZYTIGA

Last updated: July 30, 2025

Introduction

ZYTIGA (abiraterone acetate) stands as a critical therapeutic agent in the management of prostate cancer, primarily used for metastatic castration-resistant prostate cancer (mCRPC). Since its approval by the U.S. Food and Drug Administration (FDA) in 2011, ZYTIGA has become a cornerstone in oncological treatment regimens, with a broad global distribution network. Understanding its supply chain, including key suppliers of its active pharmaceutical ingredient (API), finished dosage forms, and supporting materials, is crucial for stakeholders across pharmaceutical manufacturing, distribution, and healthcare.

Manufacturing and Supply Chain Overview

The production of ZYTIGA involves complex synthetic pathways, predominantly centered around the synthesis of abiraterone acetate's API. The global supply chain comprises multiple tiers, including API manufacturers, formulation facilities, packaging entities, and distribution channels spanning North America, Europe, Asia, and emerging markets.

Key Suppliers of Abiraterone Acetate API

1. Major API Manufacturers

The primary suppliers of abiraterone acetate API are multinational pharmaceutical ingredient producers with integrated capabilities spanning synthesis, purification, and quality control. Several companies have secured supply contracts or hold manufacturing licenses for the API:

• Changzhou Sunonda Pharmaceutical Co., Ltd. (China): Recognized for manufacturing high-quality APIs, this Chinese manufacturer supplies abiraterone acetate to several generic and branded drug producers worldwide. Changzhou Sunonda emphasizes compliance with Good Manufacturing Practices (GMP) and adheres to international quality standards.

• Jiangsu Hengrui Medicine Co., Ltd. (China): A leader in oncology APIs, Hengrui supplies abiraterone acetate API to both branded and generic pharmaceutical companies. Their API production benefits from integrated research and development (R&D) and manufacturing facilities.

• Alvogen (United States / International): While primarily known for finished products, Alvogen also handles API procurement for its generic formulations, sourcing from certified API manufacturers to ensure quality standards.

• Teva Pharmaceutical Industries Ltd. (Israel): As part of its API portfolio, Teva sources abiraterone acetate from multiple manufacturers, adhering strictly to regulatory standards to support its generic ZYTIGA production.

2. Contract Manufacturing Organizations (CMOs)

Many branded pharmaceutical companies engage CMOs for API supply, which often include:

• Therapex (China): Provides contract synthesis and manufacturing of abiraterone acetate API for various clients, including branded drug developers.

• Hunan Truepharm Biotech Co., Ltd. (China): Offers API synthesis services compliant with international GMP standards.

These partnerships enable flexibility and scalability in production, reducing the risk of supply disruptions.

Finished Dosage Form Manufacturers

While Johnson & Johnson’s pharmaceutical division, Janssen Pharmaceuticals, originally developed ZYTIGA, several generic manufacturers globally now produce approved generic versions, often relying on original API suppliers:

• Mingxing Pharmaceuticals (China): Manufactures generics of ZYTIGA using imported APIs, exporting to various markets.

• Hatton Pharmaceuticals (India): Produces generic abiraterone acetate tablets, sourcing APIs from certified Chinese or Indian API producers.

• Dr. Reddy’s Laboratories (India): Produces generic formulations, sourcing APIs from multiple suppliers, including Chinese manufacturers.

Supporting and Ancillary Material Suppliers

Production of ZYTIGA requires excipients and packaging materials supplied by:

• Colorcon Inc. (United States): Supplies excipients such as microcrystalline cellulose used in tablet manufacturing.

• BASF SE (Germany): Supplies coating agents and stabilizers in the formulation process.

• Amneal Pharmaceuticals (United States): Provides blister packaging and secondary packaging components.

Regulatory and Quality Considerations

Suppliers of ZYTIGA’s API and finished formulations must comply with stringent regulatory standards, notably GMP certifications from authorities such as the FDA, EMA, and China Food and Drug Administration (CFDA). Quality assurance processes ensure batch-to-batch consistency, drug purity, and absence of contaminants, critical for oncology drugs like ZYTIGA.

Global Production and Supply Risks

The reliance on Chinese and Indian API manufacturers introduces geopolitical and logistical risks, including regulatory audits, export restrictions, and contamination concerns. Recent initiatives by Johnson & Johnson aim to diversify supply sources and invest in local manufacturing capacities in North America and Europe to mitigate disruptions.

Emerging Trends and Future Outlook

The pharmaceutical industry is witnessing a shift toward supply chain resilience through regionalization and diversification of API sources. Advances in continuous manufacturing and process intensification may also streamline production, reducing dependency on specific suppliers and geographic regions.

Conclusion

The supply landscape for ZYTIGA encompasses a broad network of reputable API manufacturers primarily in China and India, complemented by contract manufacturers and supporting material suppliers globally. Ensuring supply security involves rigorous quality control measures, diversified sourcing strategies, and adherence to international regulatory standards. As demand for prostate cancer therapies persists, building resilient and compliant supply chains remains paramount for healthcare providers and pharmaceutical stakeholders.

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Key Takeaways

• The principal API suppliers for ZYTIGA are Chinese companies such as Changzhou Sunonda Pharmaceutical and Jiangsu Hengrui Medicine, with additional sourcing from Indian and local manufacturers.
• Contract manufacturing organizations play a significant role in supplementing API supply, ensuring flexibility and capacity expansion.
• Global finished dosage forms are produced by multiple generic manufacturers, often sourcing APIs from approved suppliers.
• Regulatory compliance and quality assurance are critical in maintaining supply chain integrity for oncology drugs.
• Industry trends favor diversification and regional manufacturing investments to mitigate risks associated with geopolitical and logistical disruptions.

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FAQs

1. Who are the main API suppliers for ZYTIGA globally?
Chinese manufacturers such as Changzhou Sunonda Pharmaceutical and Jiangsu Hengrui Medicine are primary API suppliers, complemented by Indian and other international producers, all adhering to strict GMP standards.

2. Are there alternative sources for ZYTIGA’s API in case of supply disruptions?
Yes, some pharmaceutical companies maintain relationships with multiple API suppliers, including contract manufacturing organizations, to diversify risk and ensure continuous supply.

3. How does regulatory oversight impact API suppliers for ZYTIGA?
Suppliers must adhere to GMP certifications and meet regulatory standards from bodies such as the FDA, EMA, and CFDA, which influence their manufacturing practices, quality control, and export eligibility.

4. What role do contract manufacturing organizations play in ZYTIGA’s supply chain?
CMOs provide flexible API synthesis and manufacturing services, enabling larger production volumes and reducing dependency on single sources.

5. What future developments could influence ZYTIGA’s supply chain?
Industry trends toward regional manufacturing, process innovations, and supply chain diversification will enhance resilience and possibly lower costs for ZYTIGA production.

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Sources

[1] FDA approval documentation for ZYTIGA, 2011.
[2] Johnson & Johnson official reports on API sourcing and manufacturing.
[3] Market analysis reports on global API manufacturing, 2022.
[4] Regulatory guidelines from EMA and CFDA on pharmaceutical API manufacturing.