Bulk Pharmaceutical API Sources for CASODEX

Bulk Pharmaceutical API Sources for CASODEX

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-845-034
Hangzhou APIChem Technology		AC-4232
Molport		MolPort-006-808-679
Amadis Chemical		A843528

Bulk Active Pharmaceutical Ingredient (API) Sources for CASODEX

Last updated: July 28, 2025

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Introduction

Casodex (bicalutamide) is a non-steroidal anti-androgen used primarily in the treatment of prostate cancer. As a critical therapeutic agent, the supply chain for its active pharmaceutical ingredient (API) is pivotal to ensuring consistent drug availability, cost-effectiveness, and regulatory compliance. This report delineates the primary bulk API sources for Casodex, analyzing key manufacturers, sourcing dynamics, regulatory considerations, and market trends shaping the supply landscape.

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Overview of Bicalutamide as an API

Bicalutamide, chemically known as 4′-Cyano-3′-methoxy-2′-hydroxy-2-methylpropyl-1H-bicolchinan-1-one, belongs to the non-steroidal anti-androgen class. Its synthesis involves complex multi-step chemical processes, demanding high-purity specifications, stringent quality controls, and advanced manufacturing capabilities. The global demand for Casodex correlates with prostate cancer prevalence, with notable markets in North America, Europe, and Asia.

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Major API Manufacturers for Casodex

1. Teva Pharmaceutical Industries Ltd.

Overview:
Teva is recognized as one of the world’s leading generic pharmaceutical manufacturers with a significant API production footprint. It produces bicalutamide as part of its extensive portfolio of generic oncology APIs.

Supply Dynamics:
Teva's API manufacturing capabilities are largely located in Israel, India, and Europe, with certified facilities compliant with Good Manufacturing Practices (GMP). The company's scale allows for stable supply chains, competitive pricing, and adherence to international regulatory standards.

Regulatory Status:
Teva’s API for bicalutamide has been approved by major regulators including the FDA and EMA, facilitating global distribution.

2. Zhejiang Kangpai Pharmaceutical Co., Ltd. (China)

Overview:
A prominent Chinese API manufacturer specializing in hormonal and anti-cancer APIs, including bicalutamide.

Supply Dynamics:
Kangpai’s manufacturing facilities in Zhejiang deploy advanced synthetic processes, offering high-purity APIs. Chinese suppliers are increasingly recognized for cost competitiveness, though regulatory harmonization remains a challenge in some markets.

Regulatory Status:
While Chinese API manufacturers often export under CE, USP, or other standards, purchasers must ensure compatibility and proper registration in their respective jurisdictions.

3. Hainan Yangling Pharmaceutical Co., Ltd. (China)

Overview:
This company supplies bulk bicalutamide with a focus on the Asian market but also exports globally, leveraging specialized synthetic expertise in anti-androgens.

Supply Dynamics:
Hainan Yangling emphasizes rigorous process controls, aiming to meet GMP standards. Their API quality consistently aligns with international specifications, making them a reliable source.

4. Morningside Pharmaceuticals (India)

Overview:
Morningside Pharmaceuticals operates manufacturing facilities in India, offering a broad portfolio of oncology APIs, including bicalutamide.

Supply Dynamics:
Their strategic position in India allows competitive pricing, rapid scale-up capabilities, and access to global markets. They comply with global regulatory requirements, including USFDA and EU certifications.

5. Other Notable Suppliers

• Dr. Reddy’s Laboratories (India): A major generic manufacturer with API production for bicalutamide, supported by robust R&D and GMP compliance.
• Mylan (now part of Viatris): Offers API sources mainly from their Indian manufacturing units.
• Intas Pharmaceuticals (India): Supplies high-quality API conforming to international standards.

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Supply Chain and Market Trends

Global API Sourcing and Geopolitical Dynamics

The API supply chain for Casodex mainly hinges on India and China, regions with well-established manufacturing ecosystems due to cost advantages and technological capacity. Regulatory harmonization efforts and trade policies influence sourcing strategies, with some pharmaceutical firms diversifying suppliers to mitigate geopolitical risks.

Cost Considerations

Chinese and Indian manufacturers typically offer more cost-effective API options owing to lower manufacturing costs. However, import tariffs, quality standards, and intellectual property considerations can influence procurement decisions.

Regulatory and Quality Assurance

Ensuring API compliance with Pharmacopeia standards (USP, EP, JP) and GMP certifications is paramount. Regulatory agencies increasingly scrutinize API sources, emphasizing transparency, traceability, and rigorous quality controls, especially in light of the global push for Good Supply Practices (GSP).

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Future Outlook

The API market for Casodex is expected to remain stable, with potential growth driven by advances in synthetic methodologies and capacity expansion in Asia. Strategic partnerships, licensing agreements, and risk mitigation through diversified sourcing are likely to characterize the procurement landscape.

Emerging synthetic techniques aimed at improving yield, purity, and environmental sustainability will further shape API supply stability. Additionally, continuous regulatory oversight will necessitate robust quality management systems from API suppliers.

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Key Considerations for Buyers

• Quality Assurance: Prioritize suppliers with validated GMP compliance, transparent quality audits, and proven consistency.
• Regulatory Compatibility: Verify that APIs meet the necessary standards in the target markets to avoid delays.
• Supply Security: Engage multiple suppliers across regions to minimize disruption risks.
• Cost Efficiency: Balance cost advantages with quality and regulatory reliability, especially when considering Chinese and Indian sources.
• Environmental and Ethical Standards: Consider manufacturers with environmentally sustainable practices and adherence to ethical labor standards.

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Conclusion

The bulk API supply chain for Casodex predominantly revolves around reputable manufacturers in India, China, and established Western suppliers like Teva. The landscape is characterized by a strategic mix of cost efficiency, regulatory compliance, and supply reliability. As global demand persists, fostering robust, transparent, and compliant sourcing practices will be essential for pharmaceutical companies seeking to ensure uninterrupted availability of Casodex.

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Key Takeaways

• Major API sources for Casodex include Teva (Israel), Chinese manufacturers such as Zhejiang Kangpai, and Indian firms like Morningside and Dr. Reddy’s.
• Asia, particularly China and India, dominate the production of bulk bicalutamide, driven by cost-effective manufacturing.
• Suppliers must maintain GMP compliance and meet international pharmacopeial standards to ensure regulatory acceptance.
• Diversification of API sourcing mitigates geopolitical and supply chain risks.
• Advancements in synthetic processes and increasing regulatory oversight will influence future supply dynamics.

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FAQs

Q1: What are the primary regions producing API for Casodex?
A1: The primary regions are India and China, with other notable suppliers in Europe and Israel, such as Teva.

Q2: How do regulatory standards affect API sourcing for Casodex?
A2: Suppliers must meet GMP standards and pharmacopeial specifications (USP, EP) to ensure market acceptance and compliance with regulatory agencies like FDA and EMA.

Q3: Are Chinese API suppliers reliable for supplying high-quality bicalutamide?
A3: Yes, many Chinese manufacturers have achieved GMP certification and export accreditation, making them reliable if due diligence and quality assessments are conducted.

Q4: What factors influence the selection of an API supplier for Casodex?
A4: Factors include quality standards, regulatory compliance, supply capacity, cost, reliability, and traceability.

Q5: Will the supply chain for Casodex API change in the future?
A5: Likely, with increased emphasis on supply diversification, technological advancements in synthesis, and stricter regulatory requirements shaping future sourcing strategies.

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Sources:
[1] Pharmaceutical Business Reports, 2022 Industry Analysis
[2] Global API Market Review, 2023
[3] Regulatory Agencies: FDA, EMA API Certification Guidelines
[4] Company Websites: Teva, Zhejiang Kangpai, Morningside Pharmaceuticals