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Suppliers and packagers for anastrozole
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anastrozole
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | ANASTROZOLE | anastrozole | TABLET;ORAL | 090568 | ANDA | Accord Healthcare Inc. | 16729-035-10 | 30 TABLET in 1 BOTTLE, PLASTIC (16729-035-10) | 2010-06-22 |
| Accord Hlthcare | ANASTROZOLE | anastrozole | TABLET;ORAL | 090568 | ANDA | Accord Healthcare Inc. | 16729-035-15 | 90 TABLET in 1 BOTTLE, PLASTIC (16729-035-15) | 2010-06-22 |
| Accord Hlthcare | ANASTROZOLE | anastrozole | TABLET;ORAL | 090568 | ANDA | Accord Healthcare Inc. | 16729-035-16 | 500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16) | 2010-06-22 |
| Accord Hlthcare | ANASTROZOLE | anastrozole | TABLET;ORAL | 090568 | ANDA | A-S Medication Solutions | 50090-2453-0 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-2453-0) | 2010-06-22 |
| Accord Hlthcare | ANASTROZOLE | anastrozole | TABLET;ORAL | 090568 | ANDA | A-S Medication Solutions | 50090-2453-1 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-2453-1) | 2010-06-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Anastrozole
Introduction
Anastrozole is a non-steroidal aromatase inhibitor primarily used in hormone receptor-positive breast cancer treatment in postmenopausal women. Since its initial approval by the FDA in 1995, anastrozole has become a cornerstone in oncology therapy, impacting the pharmaceutical supply chain significantly. Its widespread adoption necessitates a comprehensive understanding of the key suppliers involved in the manufacturing, distribution, and commercialization of anastrozole. This article provides an in-depth analysis of the primary suppliers, market dynamics, and strategic considerations relevant to stakeholders in the pharmaceutical industry.
Overview of Anastrozole Manufacturing
Anastrozole’s production involves complex chemical synthesis processes requiring specialized active pharmaceutical ingredient (API) manufacturing capabilities. The supply chain encompasses raw material suppliers, API manufacturers, formulation specialists, and distribution channels. Major pharmaceutical giants and generic manufacturers dominate this landscape, driven by demand from oncology clinics and institutional healthcare systems globally.
Key API Suppliers for Anastrozole
1. Teva Pharmaceuticals
Teva is renowned as a leading generic medication producer, including anastrozole. With extensive API manufacturing facilities across Israel and Europe, Teva supplies both branded and generic anastrozole worldwide. The company's vertical integration and significant R&D investments enable consistent quality and supply assurances, making it a primary API supplier for markets in North America, Europe, and Asia-Pacific.
2. Mylan (now part of Viatris)
Viatris, formed from Mylan's merger with Pfizer’s Upjohn unit, supplies generic anastrozole developed through Mylan’s established API facilities. Viatris’s expansive distribution network and regulatory expertise position it as a vital supplier in emerging markets and regions with high demand for affordable oncology therapies.
3. Sun Pharmaceutical Industries
As one of India’s largest pharmaceutical companies, Sun Pharma produces the API for anastrozole through its U.S. FDA-licensed facilities. Its focus on cost-effective manufacturing and global distribution makes it a key contributor, especially in Asian and Latin American markets.
4. Jinzhou Jinshi Pharmaceutical
Based in China, Jinzhou Jinshi is a prominent API supplier specializing in steroids, hormones, and aromatase inhibitors like anastrozole. Its strategic location and manufacturing scale have helped it serve both domestic and export markets, often providing competitive pricing.
5. Apotex Inc.
This Canadian pharmaceutical company supplies both the API and finished formulations of anastrozole. Its manufacturing plants comply with stringent FDA and European Medicines Agency (EMA) standards, affirming its role as a reliable API supplier, particularly for North American and European markets.
Distribution and Outsourcing Partners
Beyond API manufacturers, the supply chain for anastrozole involves third-party logistics (3PL), contract manufacturing organizations (CMOs), and distributors that ensure drug availability across healthcare systems. Leading pharmaceutical companies tend to partner with global distributors such as McKesson, Cardinal Health, and Nippon Kayaku for efficient distribution to hospitals, pharmacies, and clinics.
Regulatory Considerations
Suppliers must adhere to strict Good Manufacturing Practices (GMP) and meet country-specific regulatory standards, including FDA, EMA, and China Food and Drug Administration (CFDA). The increasing trend of regional manufacturing in India, China, and Eastern Europe underscores efforts to mitigate supply chain risks and meet rising global demand.
Emerging Market Suppliers and Generics Competitors
The global push for affordable cancer treatments has spurred numerous regional manufacturers, especially in India and China, to enter the anastrozole market. Companies such as Aurobindo Pharma, Zydus Cadila, and Hetero Drugs have obtained regulatory approval to produce generic anastrozole, expanding supply options and fostering competition. Their manufacturing facilities often source APIs from local Chinese or Indian API producers, including Jinzhou Jinshi.
Supply Chain Challenges and Trends
- Supply Disruptions: Dependence on API imports from China and India exposes the supply chain to geopolitical and logistical disruptions. Recent global events, such as the COVID-19 pandemic, highlighted vulnerabilities, prompting companies to diversify API sourcing and increase regional manufacturing capacity.
- Regulatory Barriers: Tightening regulations and quality standards necessitate ongoing compliance efforts, creating barriers for smaller or newer API producers.
- Sustainability and Environmental Concerns: Increasing focus on environmentally sustainable manufacturing practices influences API suppliers’ operations, impacting sourcing decisions and investment in greener technologies.
Strategic Implications for Stakeholders
- Pharmaceutical Companies: Building diversified supplier networks reduces supply risks and ensures stable product availability. Partnering with certified API producers in regions with stable geopolitical climates is increasingly prioritized.
- Investors: The competitive landscape is evolving, with API production capacity a key determinant of market stability. Companies with integrated API manufacturing capabilities or strategic supplier relationships may hold competitive advantages.
- Regulatory Bodies: Ensuring API quality from diverse suppliers requires rigorous oversight, especially with regional expansion of manufacturing bases.
Key Takeaways
- Major API suppliers for anastrozole include Teva, Viatris, Sun Pharma, Jinzhou Jinshi, and Apotex, each with extensive manufacturing capabilities.
- Geographic diversification in API production, notably in India and China, underpins global supply stability but introduces geopolitical and regulatory challenges.
- The industry is witnessing increased competition from regional generic manufacturers, driven by cost pressures and regulatory approvals.
- Supply chain resilience necessitates strategic partnerships, regional manufacturing expansion, and adherence to evolving quality standards.
- Environmental and sustainability considerations influence supplier selection and operational practices within the anastrozole supply ecosystem.
FAQs
1. Who are the leading API manufacturers for anastrozole globally?
The leading API manufacturers include Teva Pharmaceuticals, Viatris (formerly Mylan), Sun Pharma, Jinzhou Jinshi, and Apotex, each supplying large portions of the global market.
2. How has the COVID-19 pandemic affected anastrozole supply chains?
The pandemic disrupted raw material sourcing, particularly from China and India, causing delays and shortages. This has accelerated efforts to regionalize manufacturing and diversify supply sources.
3. Are there regional differences in anastrozole API sourcing?
Yes. North America and Europe rely heavily on suppliers like Teva and Apotex, while Asia depends largely on Jinzhou Jinshi and regional Indian manufacturers. These differences impact supply stability and regulatory compliance.
4. What regulatory standards must API suppliers for anastrozole meet?
Suppliers must comply with GMP standards set by agencies like the FDA, EMA, and CFDA, ensuring drug safety, quality, and efficacy for global markets.
5. What trends are shaping the future of anastrozole supply?
Key trends include regional manufacturing expansion, increased supply chain transparency, environmental sustainability, and the rise of generic competition, all aimed at ensuring consistent, affordable access to this essential drug.
References
- U.S. Food and Drug Administration (FDA), Drug Approvals and Regulatory Information.
- European Medicines Agency (EMA), Market Authorization of Anastrozole.
- Industry Reports, Global API Market Analysis, 2022.
- Company Websites: Teva, Viatris, Sun Pharma, Jinzhou Jinshi, Apotex.
- Market Insights, Trends in Oncology Drugs and Supply Chain Resilience.
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