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Suppliers and packagers for BICALUTAMIDE
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BICALUTAMIDE
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 | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917 | ANDA | Major Pharmaceuticals | 0904-6019-46 | 30 TABLET in 1 BOTTLE (0904-6019-46) | 2010-05-11 |
| Accord Hlthcare | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917 | ANDA | Northstar RxLLC | 16714-816-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-816-01) | 2018-06-01 |
| Accord Hlthcare | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917 | ANDA | Accord Healthcare Inc. | 16729-023-01 | 100 TABLET in 1 BOTTLE (16729-023-01) | 2009-07-06 |
| Accord Hlthcare | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917 | ANDA | Accord Healthcare Inc. | 16729-023-10 | 30 TABLET in 1 BOTTLE (16729-023-10) | 2009-07-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BICALUTAMIDE
Introduction
Bicalutamide is an oral non-steroidal anti-androgen widely used in the treatment of prostate cancer. Its role in hormone therapy makes it a critical compound within oncology pharmaceuticals. As demand for prostate cancer therapies continues to rise globally, especially with aging populations, the procurement chain for bicalutamide has become a strategic concern for healthcare providers, generic manufacturers, and pharmaceutical distributors. This article provides an in-depth analysis of the primary suppliers of bicalutamide, the manufacturing landscape, market dynamics, and implications for stakeholders.
Manufacturing Landscape of Bicalutamide
Bicalutamide is synthesized through complex chemical processes that demand high purity chemicals and specialized manufacturing capabilities. The key to successful supply hinges on the presence of robust API (Active Pharmaceutical Ingredient) producers, reliable intermediates suppliers, and contract manufacturing organizations (CMOs).
Major pharmaceutical manufacturers and API producers globally serve as primary sources. The competitiveness in this market stems from the capacity for large-scale synthesis, process optimization, and regulatory compliance, notably with Good Manufacturing Practice (GMP) standards.
Major Suppliers and Manufacturers
1. Teva Pharmaceuticals
Overview: An Israeli multinational, Teva is among the leading generic drug manufacturers with a significant portfolio of oncology-related APIs, including bicalutamide.
Capabilities: Teva operates manufacturing facilities in Israel, India, and Europe, with ISO-certified production lines for high-volume API synthesis. Their long-standing presence in the chemotherapeutic segment underpins their reputation as a reliable supplier.
Market Position: Teva’s extensive global distribution network ensures wide availability of bicalutamide APIs and finished formulations. Their investments in advanced synthesis and quality control underpin their market dominance.
2. Mylan (Now part of Viatris)
Overview: Mylan, acquired by Viatris in 2020, is a leading global generics manufacturer with API manufacturing plants in India, Europe, and North America.
Capabilities: The company’s manufacturing facilities are certified under GMP, with proven capacity to produce bicalutamide at scale, meeting international quality standards.
Market Position: Mylan’s strategic focus on affordability and supply chain resilience positions it as a key supplier for both generic and branded formulations.
3. Jiangsu Hengrui Medicine Co., Ltd.
Overview: A leading Chinese pharmaceutical innovator and API manufacturer, Hengrui has increased its market share through aggressive R&D and API production capabilities.
Capabilities: Their manufacturing facilities in China adhere to GMP standards, producing high-purity APIs pertinent to oncology therapeutics, including bicalutamide.
Market Position: Chinese API producers like Hengrui are becoming increasingly prominent, supplying both domestic and international markets, often at competitive prices.
4. Jiangxi Biici Pharmaceutical Co., Ltd.
Overview: An emerging Chinese API producer focusing on synthetic APIs for oncology drugs.
Capabilities: They manufacture bicalutamide intermediates and APIs with compliance to GMP and ISO standards.
Market Position: Their cost-effective production offers options for generic drug manufacturers seeking lower-cost sources.
5. Dr. Reddy’s Laboratories
Overview: An Indian multinational with capabilities in API synthesis and manufacturing of oncology pharmaceuticals.
Capabilities: Dr. Reddy’s operates GMP-certified facilities capable of producing high-quality bicalutamide APIs for global markets.
Market Position: Their strategic focus on quality and affordability makes them a preferred supplier for many generic drug companies.
Emerging and Contract Manufacturing Options
In addition to these primary suppliers, a growing number of contract manufacturing organizations (CMOs) are entering the bicalutamide supply chain. These include companies based in India, China, and Eastern Europe, offering scalable manufacturing solutions, often at lower costs, with the potential to meet stringent international regulatory standards.
Market Dynamics and Supply Chain Considerations
Global Demand and Supply: The rising incidence of prostate cancer, especially in men over 60, drives consistent demand for bicalutamide globally. The prevalence in North America, Europe, and increasingly in Asia-Pacific regions necessitates diversified supply sources.
Regulatory Factors: Suppliers must comply with stringent regulatory standards from authorities like the FDA, EMA, and PMDA. GMP certification, rigorous quality assurance, and transparent documentation define the supplier qualifying criteria.
Price Trends: The proliferation of Chinese and Indian API producers has historically exerted downward pressure on prices, fostering a competitive environment. However, supply chain disruptions, geopolitical considerations, and regulatory hurdles can lead to intermittencies, emphasizing the importance of diversified supplier portfolios.
Supply Chain Resilience: Recent global events, including the COVID-19 pandemic, have underscored vulnerabilities in the supply chain. Pharmaceutical companies are increasingly seeking dual or multiple sourcing strategies to mitigate risks associated with sole-supplier dependencies.
Implications for Stakeholders
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For Buyers: Engaging with multiple suppliers, verifying GMP compliance, and establishing long-term contracts ensure supply stability. Importantly, assessing the quality certifications and capacity for regulatory compliance is critical.
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For Suppliers: Maintaining transparent quality standards, expanding production capacity, and aligning with regulatory requirements are essential for capturing global market share.
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For Regulators: Ensuring manufacturing compliance and inspection readiness remain vital to safeguard drug safety and supply integrity.
Conclusion
The supply landscape for bicalutamide is predominantly characterized by established players like Teva, Mylan, Dr. Reddy’s, and Chinese API producers such as Jiangsu Hengrui. The global demand for prostate cancer therapeutics continues to underpin this market. Firms seeking reliable sources should prioritize suppliers with GMP certification, proven capacity for large-scale synthesis, and compliance with international regulatory standards. Diversification of supply sources remains a prudent strategy amid geopolitical and economic uncertainties.
Key Takeaways
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Major global suppliers include Teva, Mylan (Viatris), Dr. Reddy’s, and Chinese manufacturers such as Jiangsu Hengrui.
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Chinese API producers are gaining prominence owing to cost competitiveness, but regulatory compliance remains critical.
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Diversification and quality assurance are vital in mitigating supply chain risks for bicalutamide.
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Regulatory compliance, especially GMP certification, ensures market access and safety standards.
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Emerging CMOs provide scalable manufacturing options but require thorough validation and vetting.
FAQs
1. What are the primary factors to consider when sourcing bicalutamide suppliers?
Quality compliance (GMP certification), manufacturing capacity, regulatory track record, supply chain stability, and pricing are key considerations.
2. How does Chinese API manufacturing impact the global supply of bicalutamide?
Chinese manufacturers provide cost-effective production options that increase market competition but require rigorous quality control to meet international standards.
3. Are there any risks associated with sourcing bicalutamide from emerging Chinese APIs?
Potential risks include regulatory hurdles, quality variability, and geopolitical considerations. Due diligence and validation are essential for assurance.
4. How have recent global events affected the bicalutamide supply chain?
Disruptions due to COVID-19 highlighted vulnerabilities, prompting companies to diversify suppliers and explore regional manufacturing options.
5. What trends are shaping the future supply of bicalutamide?
Growing demand for prostate cancer therapies, increased outsourcing to CMOs, and emphasis on regulatory compliance will influence the supply chain landscape.
References
[1] Pharma Intelligence, "Active Pharmaceutical Ingredient (API) Market Report," 2022.
[2] U.S. Food and Drug Administration (FDA), "Manufacturing Requirements for Oncology Drugs," 2023.
[3] GlobalData, "Prostate Cancer Therapeutics Market Trends," 2022.
[4] International Council for Harmonisation (ICH), "GMP Guidelines," 2023.
[5] IQVIA, "Global API Manufacturing & Supply Overview," 2022.
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