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Suppliers and packagers for generic pharmaceutical drug: ABIRATERONE ACETATE
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ABIRATERONE ACETATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327 | ANDA | AvKARE | 42291-024-12 | 120 TABLET in 1 BOTTLE (42291-024-12) | 2019-01-14 |
| Amneal Pharms | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1165-7 | 120 TABLET in 1 BOTTLE (60219-1165-7) | 2023-04-28 |
| Amneal Pharms | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1754-6 | 60 TABLET in 1 BOTTLE (60219-1754-6) | 2023-04-28 |
| Amneal Pharms | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327 | ANDA | American Health Packaging | 60687-790-21 | 30 BLISTER PACK in 1 CARTON (60687-790-21) / 1 TABLET in 1 BLISTER PACK (60687-790-11) | 2024-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ABIRATERONE ACETATE
Introduction
Abiraterone acetate is a pivotal pharmaceutical ingredient used in the treatment of metastatic castration-resistant prostate cancer (mCRPC). This drug, marketed under brand names like Zytiga, significantly prolongs survival and improves quality of life for patients, making its supply chain critical for healthcare providers and pharmaceutical companies worldwide. The global demand for abiraterone acetate hinges on reliable suppliers capable of providing high-quality active pharmaceutical ingredients (APIs), intermediates, and finished formulations. This report details the key suppliers, their geographic distribution, manufacturing capacity, regulatory landscape, and strategic implications for pharmaceutical stakeholders.
Overview of Abiraterone Acetate Production
Abiraterone acetate, a selective inhibitor of cytochrome P450 17A1 (CYP17A1), is synthesized through complex chemical processes requiring specialized manufacturing facilities. It is classified as a high-value API with stringent quality standards mandated by regulatory authorities like the FDA, EMA, and PMDA. The supply chain involves multiple tiers, including raw material providers, API manufacturers, formulation specialists, and distributors.
Leading Suppliers of Abiraterone Acetate
1. Johnson Matthey
Profile: Johnson Matthey is a global leader in the production of advanced catalysts, chemicals, and precious metals. They supply both APIs and manufacturing catalysts to the pharmaceutical industry.
Role in Abiraterone Acetate Supply: Johnson Matthey chemically synthesizes key intermediates and provides catalytic processes used in the manufacturing of abiraterone acetate. Their facilities are GMP-compliant, ensuring high purity and consistent quality.
Capacity & Distribution: With a global footprint across Europe, North America, and Asia, Johnson Matthey's capacity supports large-scale production, serving prominent pharmaceutical companies worldwide.
2. Patheon (Thermo Fisher Scientific)
Profile: Patheon, now part of Thermo Fisher Scientific, is a contract manufacturing organization (CMO) specializing in API production and formulation services.
Role: They manufacture finished abiraterone acetate formulations and provide development services. Their facilities adhere to strict regulatory standards, and they serve as a strategic partner for pharmaceutical brands seeking reliable supply.
Capacity & Distribution: With manufacturing sites in North America, Europe, and Asia, Patheon ensures flexible supply chain options tailored to client needs.
3. Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China)
Profile: A prominent Chinese pharmaceutical manufacturer specializing in APIs, Jiangshan-based Zhejiang Jiuzhou has emerged as a key supplier of abiraterone acetate.
Role: The company produces bulk API batches that meet international quality standards. Their cost competitiveness makes them an attractive supplier, especially for emerging markets and large-volume buyers.
Capacity & Regulatory Status: While their manufacturing capacity has expanded rapidly, regulatory approvals for export to Western markets are ongoing, with some batches approved by the China FDA and EMA.
4. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Profile: Hisun Pharmaceuticals is a publicly traded company recognized for its extensive API portfolio, including abiraterone acetate.
Role: The firm supplies bulk API batches directly to global pharmaceutical companies and contract manufacturers.
Regulatory and Quality Standards: Hisun adheres to GMP standards, with several of their APIs approved for sale in the US, Europe, and Japan.
5. Akorn Pharmaceuticals and Other North American Suppliers
Profile: Akorn specializes in generic APIs and finished dosage forms, including abiraterone acetate, primarily serving North American markets.
Role: They provide finished pharmaceutical products and often act as secondary suppliers or distributors of APIs for regional applications.
Regulatory Status: Akorn's manufacturing facilities are FDA-approved, ensuring compliance with US standards.
Emerging and Regional Suppliers
The landscape for abiraterone acetate is expanding, with regional manufacturers in India, South Korea, and Southeast Asia gaining prominence:
- Dr. Reddy’s Laboratories (India): Engages in API manufacturing with an increasing focus on oncology agents, including abiraterone acetate. They operate in compliance with local and international standards.
- Samsung BioLogics (South Korea): Has capabilities for biopharmaceuticals and clinical supply, with studies indicating potential expansion into small-molecule APIs like abiraterone acetate.
Regulatory and Quality Considerations
Suppliers of abiraterone acetate must navigate complex regulatory frameworks that demand rigorous GMP compliance. Approval processes involve validation of manufacturing processes, impurity profiles, and stability data. Leading suppliers obtain approvals from the FDA, EMA, PMDA, and China FDA, providing assurance of product quality and regulatory compliance.
Supply chain resilience hinges on diversification of sources, strict quality controls, and strategic partnerships. Recent global disruptions, such as the COVID-19 pandemic, have accentuated the importance of reliable, multi-regional suppliers to mitigate risks.
Strategic Implications for Pharmaceutical Companies
- Vendor diversification reduces dependency risks posed by geopolitical tensions, regulatory hurdles, or supply chain disruptions.
- Cost considerations favor sourcing from high-capacity Asian manufacturers, balanced against regulatory and quality standards.
- Technology transfer and licensing agreements can facilitate access to proprietary synthesis processes, ensuring supply continuity.
- Manufacturing scalability must align with projected demand, especially as abiraterone acetate gains broader indications.
Conclusion
The supply of abiraterone acetate involves a complex network of global suppliers with varying capacity, regulatory approval status, and strategic positioning. While established players like Johnson Matthey and Patheon dominate in high-quality API provision, emerging suppliers in China and other regions present cost-effective alternatives that are increasingly meeting international standards. Navigating this landscape requires a focus on regulatory compliance, quality assurance, and supply chain resilience.
Key Takeaways
- Reliable procurement of abiraterone acetate depends on a diversified supplier network encompassing established Western manufacturers and emerging Asian producers.
- Regulatory compliance with GMP standards remains paramount; suppliers with approvals from major authorities are preferred.
- Cost advantages from Asian suppliers must be balanced with quality assurance measures.
- Strategic partnerships and licensing agreements are essential in securing scalable, uninterrupted supply.
- Supply chain resilience is increasingly vital amid global disruptions, making supplier diversification and regulatory diligence critical.
FAQs
1. Which are the top global suppliers of abiraterone acetate?
Leading suppliers include Johnson Matthey, Patheon (Thermo Fisher Scientific), Zhejiang Jiuzhou Pharmaceutical, and Zhejiang Hisun Pharmaceutical, all of which meet international regulatory standards.
2. Are Chinese manufacturers of abiraterone acetate approved for export to Western markets?
Some Chinese manufacturers have obtained or are in the process of obtaining approvals from agencies like the EMA and FDA. Regulatory approval varies by manufacturer and product batch, requiring careful due diligence.
3. What factors influence the choice of a supplier for abiraterone acetate?
Key factors include regulatory compliance, manufacturing capacity and scalability, product quality, price competitiveness, supply chain reliability, and geopolitical considerations.
4. How has the COVID-19 pandemic affected abiraterone acetate supply chains?
Disruptions have underscored the importance of diversified sources and regional manufacturing capacity, prompting pharmaceutical firms to reassess supply chain strategies for critical APIs.
5. What future trends are expected in the abiraterone acetate supply market?
Emerging players in Asia are likely to increase their market share, accompanied by technological advancements in synthesis processes. Regulatory harmonization and supply chain resilience will remain strategic priorities.
Sources
[1] GlobalData Pharmaceutical Intelligence, 2022.
[2] U.S. Food and Drug Administration (FDA), Approved Drug Products, 2023.
[3] European Medicines Agency (EMA), Variations and Approvals, 2023.
[4] Company disclosures and industry reports, 2022-2023.
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