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Suppliers and packagers for CASODEX
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CASODEX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498 | NDA | Golden State Medical Supply, Inc. | 51407-010-30 | 30 TABLET in 1 BOTTLE (51407-010-30) | 1995-10-04 |
| Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498 | NDA | ANI Pharmaceuticals, Inc. | 62559-680-30 | 30 TABLET in 1 BOTTLE (62559-680-30) | 2018-06-26 |
| Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498 | NDA | ANI Pharmaceuticals, Inc. | 62559-890-30 | 30 TABLET in 1 BOTTLE (62559-890-30) | 2020-10-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CASODEX (Bicalutamide)
Introduction
CASODEX, known generically as Bicalutamide, is an oral non-steroidal anti-androgen primarily prescribed for the treatment of prostate cancer. Its mechanism involves antagonizing androgen receptors, thereby impeding tumor growth. As a critical component in prostate cancer management, Bicalutamide's supply chain is vital for healthcare systems worldwide. This article explores the leading suppliers, manufacturing landscape, and key considerations for pharmaceutical companies and healthcare providers seeking reliable sources of CASODEX.
Overview of CASODEX (Bicalutamide)
Bicalutamide, marketed under the brand name CASODEX by AstraZeneca, was approved globally for prostate cancer therapy. Its chemical name is (R)-2-(4-fluorophenyl)-3-(4-cyaanophenyl)-4-oxo-5-(trifluoromethyl)-1,2-dihydro-3H-pyrazole-3-carboxamide. It’s available in various formulations, including 50 mg, 150 mg tablets, and often as part of combination therapies.
The drug's manufacturing relies on complex chemical synthesis processes, regulatory compliance, and high standards of quality assurance, making supplier selection critical for pharmaceutical distributors and healthcare entities.
Major Suppliers of CASODEX (Bicalutamide)
1. Original Manufacturer: AstraZeneca
- Market Presence: AstraZeneca holds the patent and original manufacturing rights for CASODEX globally. As the originator, they maintain quality standards, supply chain integrity, and regulatory approvals.
- Manufacturing Facilities: AstraZeneca has production sites in Europe, North America, and emerging markets. Their manufacturing processes adhere to Good Manufacturing Practices (GMP), ensuring drug quality and consistency.
- Availability: AstraZeneca directly supplies CASODEX to large pharmaceutical distributors, hospitals, and government agencies, often through regional subsidiaries or authorized distributors.
2. Contract Manufacturing Organizations (CMOs)
- CMO Landscape: Several pharmaceutical CMOs possess capacity to produce Bicalutamide under licensing agreements with AstraZeneca or through independent manufacturing for genericization. These CMOs may supply both original and generic versions.
- Key Players:
- Hetero Labs (India): Known for generic APIs and finished dosage forms, Hetero supplies Bicalutamide certified for international markets.
- Mersana Therapeutics (USA): Engaged in advanced contract manufacturing, including Bicalutamide synthesis.
- Synthesis-pharma firms in China and India: Numerous regional players manufacture Bicalutamide APIs at scale, adhering to international GMP standards, serving both global generics markets and regional needs.
3. Generic Manufacturers
- Global Generics Market: Post patent expiry or license agreements, multiple pharmaceutical companies manufacture generic versions of Bicalutamide, often at lower costs to improve affordability.
- Leading Generics Suppliers:
- Sun Pharmaceutical Industries (India): Offers Bicalutamide API and finished products.
- Aurobindo Pharma (India): Produces Bicalutamide API, complying with international standards.
- Teva Pharmaceuticals (Israel): Supplies generic Bicalutamide formulations.
- Hunan Yuxin Pharmaceutical (China): Engages in Bicalutamide API manufacturing.
- These companies typically distribute through regional and international supply channels and often provide competitive pricing.
Supply Chain Dynamics and Procurement Considerations
Quality and Regulatory Compliance
Ensuring API and finished product quality is paramount. Suppliers must comply with GMP, ISO standards, and meet regulatory approvals from agencies like the FDA, EMA, or PMDA. Certificates of Analysis (CoA), stability data, and batch consistency are critical indicators.
Manufacturing Capacity and Lead Times
Given the demand for prostate cancer treatments, supply chain stability depends on manufacturers' capacity. Disruptions due to geopolitical issues, pandemics, or raw material shortages can impact availability. Firms should evaluate manufacturers’ capacity, contingency plans, and historical reliability.
Pricing and Licensing
Patents influence initial pricing. Once patent exclusivity ends, generics significantly reduce costs, expanding access. Licensing agreements between originators and generics firms influence market competition and supply diversity.
Regional Distribution and Accessibility
Regional regulatory approvals and local manufacturing influence availability. Companies should consider suppliers with a strong presence in target markets to ensure timely deliveries and regulatory compliance.
Emerging Trends and Future Outlook
- Bioconvergence and API Innovation: Automation and process improvements enhance manufacturing efficiency.
- Geopolitical Factors: Trade policies and regional regulatory changes may influence supplier options.
- Supply Chain Resilience: Companies are increasingly diversifying suppliers to mitigate risks associated with dependency on specific regions or manufacturers.
Conclusion
The supply landscape for CASODEX (Bicalutamide) encompasses original manufacturers like AstraZeneca and a broad spectrum of generic producers across India, China, and other regions. Ensuring a reliable, high-quality supply chain requires vigilance in regulatory compliance, manufacturing capacity, and geographic diversification. Healthcare providers and pharmaceutical companies should establish robust verification processes and foster strategic partnerships to ensure uninterrupted access to this vital prostate cancer medication.
Key Takeaways
- Primary Source: AstraZeneca remains the original manufacturer, maintaining high standards and regulatory approvals.
- Generic Market: Multiple Indian, Chinese, and global pharmaceutical companies produce Bicalutamide, offering cost-effective options.
- Quality Assurance: Always verify manufacturers’ GMP, ISO certifications, and regulatory compliance.
- Supply Chain Resilience: Diversify suppliers and establish contingency plans to mitigate geopolitical and logistical risks.
- Future Trends: Advances in manufacturing and regional market developments influence supply dynamics and pricing strategies.
FAQs
Q1: How can healthcare providers verify the authenticity of Bicalutamide supplied?
Healthcare providers should request Certificates of Analysis (CoA), batch release certificates, and ensure suppliers hold GMP and ISO certifications. Purchasing from reputable distributors and directly from licensed manufacturers reduces counterfeit risks.
Q2: Are generic Bicalutamide products as effective as the original?
Yes, if manufactured following strict regulatory standards, generic versions are bioequivalent and therapeutically equivalent to the original product. Confirming regulatory approvals from agencies like the FDA or EMA assures quality.
Q3: What are the risks associated with relying on regional suppliers for Bicalutamide?
Risks include regulatory delays, geopolitical disruptions, raw material shortages, and quality inconsistencies. Diversification and rigorous quality checks mitigate these risks.
Q4: How has patent expiration affected the supply of Bicalutamide?
Patent expiry has expanded the global supply through generic manufacturing, reducing prices and increasing access. It also spurs innovation in manufacturing processes and quality improvements.
Q5: What should companies consider when selecting a supplier for Bicalutamide?
Key considerations include regulatory compliance, manufacturing capacity, quality standards, price competitiveness, delivery reliability, and regional presence for faster market access.
References
- AstraZeneca. (2021). Casodex (Bicalutamide) Product Information.
- World Health Organization. (2020). Global API and Finished Dosage Market Reports.
- U.S. Food and Drug Administration. (2022). Approved Drug Products Database.
- Indian Pharmaceutical Industry Reports. (2021). Market Overview and Leading Manufacturers.
- Chinese Pharmaceutical Industry. (2020). API Manufacturing and Export Data.
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