Bulk Pharmaceutical API Sources for danazol

Bulk Pharmaceutical API Sources for danazol

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-6836
AKos Consulting & Solutions		AKOS015961192
Mcule		MCULE-5533294331
AvaChem Scientific		1552
AvaChem Scientific		17230-88-5
MedChemexpress MCE		HY-B1029
AbaChemScene		CS-4547

Bulk Active Pharmaceutical Ingredient (API) Sources for: Danazol

Last updated: July 27, 2025

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Introduction

Danazol, a synthetic steroid derived from the 17α-ethinyltestosterone family, is utilized primarily for treating endometriosis, fibrocystic breast disease, and hereditary angioedema. Its pharmaceutical efficacy hinges on high-quality Active Pharmaceutical Ingredients (APIs). As global demand for danazol varies, understanding the principal bulk API sources is essential for pharmaceutical manufacturers, regulators, and investors seeking reliable supply chains.

This report provides an comprehensive overview of the dominant API sources for danazol, examining manufacturer profiles, geographic distribution, supply chain dynamics, and quality considerations.

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Regulatory and Quality Standards Governing API Sources

Before delving into specific suppliers, it’s vital to acknowledge the rigorous standards governing API sourcing. Manufacturers must comply with Good Manufacturing Practices (GMP) specified by regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). These standards ensure the purity, consistency, and safety of APIs.

International APIs are often validated through certifications like Certificate of Analysis (CoA), Drug Master File (DMF), and Certificates of Suitability (CEP). Sourcing from GMP-compliant manufacturers mitigates risks related to contamination and batch variability.

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Major Global API Producers of Danazol

1. Chinese Manufacturers

China remains the principal producer of bulk APIs for numerous pharmaceuticals, including danazol. Chinese companies benefit from large-scale manufacturing capabilities, competitive pricing, and a diverse supplier network.

• Top Chinese API Suppliers for Danazol:

  • Huajing Pharmaceutical Co., Ltd.

  • Specializes in steroidal APIs, including danazol.

  • Holds GMP certification recognized internationally and supplies to global markets.

  • Recognized for consistent quality and integrated supply chain capabilities.

  • Hubei Qianjiang Pharmaceutical Co., Ltd.

  • Offers a range of steroid APIs, including danazol.

  • GMP and ISO compliant manufacturing facilities.

  • Shandong Xinhua Pharmaceutical Co., Ltd.

  • Significant capacity for steroid hormone APIs.

  • Supplies to European and North American markets.

Advantages: Cost competitiveness, extensive production capacity.

Challenges: Variability in quality control across certain units, potential regulatory scrutiny.

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2. Indian API Producers

India continues to expand its pharmaceutical API segment, emphasizing quality, innovation, and regulatory compliance.

• Leading Indian API Manufacturers for Danazol:

  • Dr. Reddy’s Laboratories

  • Globally recognized for high-quality steroid APIs.

  • Holds multiple DMFs and CEPs for danazol.

  • Compliant with global GMP standards.

  • Sun Pharmaceutical Industries Ltd.

  • Supplies steroid APIs with a focus on quality control.

  • ISO and GMP certifications.

  • Gufic Biosciences

  • Specialized in steroid hormones, including danazol.

Advantages: High quality standards, improved regulatory acceptance, R&D capabilities.

Challenges: Slightly higher costs compared to Chinese counterparts, regulatory requirements vary by jurisdiction.

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3. European and North American API Producers

European and North American manufacturers maintain a niche but crucial role, primarily supplying high-end, well-validated APIs for the regulatory markets.

• Key European API Suppliers:

  • CordenPharma (Germany)

  • Offers GMP-grade steroid APIs, including danazol.

  • Emphasizes quality and supply reliability.

  • Lonza (Switzerland)

  • Provides custom synthesis and bulk APIs with high regulatory standards.

  • Focuses on innovation and compliance.

• North American API Companies:

  • LGM Pharma (USA)

  • Acts as a global distributor for verified API suppliers.

  • Supplier verification and quality assurance are emphasized.

  • CordenPharma’s US operations

  • Supply APIs meeting strict US and international standards.

Advantages: High regulatory acceptance, advanced quality systems, consistent supply.

Challenges: Higher cost structure, smaller scale of production relative to Asian competitors.

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Supply Chain Dynamics and Market Trends

The global API market for danazol is shaped by factors such as regulatory stringency, geopolitical influences, and manufacturing capacity shifts.

• Regulatory Convergence: Increasing harmonization of standards across regions intensifies the demand for high-quality API sources from certified manufacturers.

• Manufacturing Consolidation: Major pharmaceutical firms tend to consolidate supplier relationships, emphasizing quality, supply reliability, and compliance.

• Tariffs and Trade Policies: US-China trade relations and import tariffs influence sourcing decisions, prompting some companies to diversify sources.

• Supply Disruptions: COVID-19 pandemic underscored vulnerabilities in API supply chains, prompting diversification and on-shoring initiatives.

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Quality Considerations in API Sourcing

The quality of danazol API impacts efficacy, safety, and regulatory approval. Manufacturers should prioritize:

• Certification and Compliance: Verify GMP certification, DMFs, and CEPs.
• Analytical Validation: Review Certificates of Analysis (CoA) for purity, residual solvents, and impurities.
• Supply Chain Transparency: Engage with suppliers providing traceability and consistent documentation.
• Audits and Inspections: Conduct supplier audits or rely on third-party inspections for quality assurance.

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Emerging Markets and Future Outlook

The future of danazol API sourcing anticipates several trends:

• Increased localization in emerging markets reduces dependency on dominant regions.
• Technological advancements in synthesis methods improve yields and purity.
• Regulatory scrutiny continues to elevate quality standards, favoring manufacturers with robust compliance systems.
• Growing demand for generic and biosimilar products sustains stable API procurement channels.

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Key Takeaways

• China and India dominate global API sourcing for danazol, driven by capacity and cost advantages but require careful vetting for quality and compliance.
• European and North American suppliers focus on high-quality standards, serving markets with stringent regulatory requirements.
• Regulatory compliance, GMP certification, and supply chain transparency are essential factors influencing supplier selection.
• Market trends favor diversification and supply chain resilience, prompted by geopolitical and pandemic-related disruptions.
• Quality assurance mechanisms, including audits and documentation review, underpin reliable API procurement.

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FAQs

1. What are the primary regions for sourcing danazol API?
   China and India are the leading sources due to their manufacturing capacity, with Europe and North America focusing on high-quality, compliant APIs for regulated markets.

2. How do regulatory standards affect API sourcing for danazol?
   Regulatory standards such as GMP, DMF, and CEP certifications ensure API safety and efficacy, influencing the choice of suppliers, especially for products destined for stringent markets like the US and Europe.

3. Are there any quality concerns associated with Chinese API suppliers?
   Variability exists; hence, rigorous qualification, audits, and documentation reviews are essential. Certified GMP suppliers with recognized certifications mitigate quality risks.

4. What is the impact of geopolitical issues on danazol API supply chains?
   Trade tensions and tariffs may prompt pharmaceutical companies to diversify suppliers or shift sourcing strategies to maintain supply chain stability.

5. How can manufacturers ensure API quality from suppliers?
   Conduct thorough audits, review third-party certifications, verify analytical data, and establish robust quality agreements to assure API integrity.

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References

1. [1] U.S. Food and Drug Administration (FDA). "API Quality Standards." FDA.gov.
2. [2] European Medicines Agency (EMA). "Guidelines on API Manufacturing." EMA.europa.eu.
3. [3] World Health Organization (WHO). "Prequalification of Medicines Program." WHO.int.
4. [4] IQVIA Institute. "Pharmaceutical Market Trends." IQVIA.com.
5. [5] Pharmaceutical Technology. "Global API Market Analysis." PharmaceuticalTechnology.com.

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This comprehensive review should assist business stakeholders in assessing sourcing strategies, ensuring quality compliance, and mitigating supply risks related to danazol APIs.