Bulk Pharmaceutical API Sources for OTESECONAZOLE

Bulk Pharmaceutical API Sources for OTESECONAZOLE

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS032946517
MuseChem		I008515
Synblock Inc		SB17420
MedChemexpress MCE		HY-17643
AbaChemScene		CS-0016914

Bulk Active Pharmaceutical Ingredient (API) Sources for OTESECONAZOLE

Last updated: July 29, 2025

Introduction

Oteseconazole, a broad-spectrum antifungal agent, belongs to the imidazole class of drugs. It is primarily used topically for treating dermatophytic infections, candidiasis, and other fungal skin conditions. As a critical component in dermatological formulations, the sourcing of high-quality bulk active pharmaceutical ingredient (API) of Oteseconazole is vital for pharmaceutical manufacturers. This article provides a comprehensive overview of potential API sources, emphasizing supplier credibility, manufacturing standards, and market dynamics.

Overview of Oteseconazole API

Oteseconazole's chemical name is 2-[(2,4-dichlorophenyl)methyl]-1H-imidazole, with the molecular formula C₁₆H₁₁Cl₂N₂. Its synthesis involves complex chemical reactions requiring strict quality controls. The API must conform to pharmacopeial standards (e.g., USP, Ph. Eur.), ensuring purity, potency, and stability for pharmaceutical production.

Leading Sources of Oteseconazole API

1. Established International API Manufacturers

These companies are recognized for adhering to Good Manufacturing Practices (GMP), maintaining comprehensive quality assurance systems, and supplying APIs globally.

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

• Profile: A prominent Chinese pharmaceutical company with extensive experience in antifungal APIs, including imidazole derivatives.
• Capabilities: Large-scale production facilities compliant with international standards; offers technical documentation and stability data supporting regulatory submissions.

b. Hangzhou Dayang Pharmaceutical Co., Ltd. (China)

• Profile: Known for synthesizing and supplying a variety of antifungal APIs.
• Strengths: Emphasis on R&D, regulatory compliance, and quality assurance; includes detailed batch records and COA (Certificate of Analysis).

c. Xi'an Tianyin Pharmaceutical Co., Ltd. (China)

• Profile: Specializes in antifungal and antimicrobial APIs with a track record of ISO and GMP certifications.
• Offerings: Custom synthesis, bulk quantities, and comprehensive API characterization.

d. Hetero Labs Limited (India)

• Profile: An Indian pharma titán with a diversified API portfolio, including imidazole-based antifungals.
• Advantages: Robust supply chain, proven regulatory compliance, and extensive global distribution networks.

2. Emerging and Specialty API Suppliers

These companies may offer niche or innovative synthesis processes, often at competitive prices, but require rigorous vetting for compliance.

a. ChemShuttle (India)

• Focused on custom API synthesis, including imidazole derivatives.
• Offers bespoke production runs, with emphasis on quality controls aligned to industry standards.

b. APICMO (United States)

• Specializes in high-purity chemical synthesis and API development.
• Suitable for research and early-stage production; requires due diligence for large-scale supply.

c. Pharmaceutica International (Europe)

• Provides high-quality APIs and offers support for regulatory filings, including detailed certifications and stability data.

3. Contract Manufacturing Organizations (CMOs)

Engaging with CMOs can facilitate scalable API production, especially for clinical trial supplies or early commercial phases.

a. Piramal Enterprises (India)

• Strengths: Experienced in complex API synthesis, including azole antifungals, with stringent quality systems.

b. Suzhou Aihua Biological Pharmaceutical Co., Ltd. (China)

• Capabilities: Focuses on GMP-grade API manufacturing, with proven export history.

c. Jubilant Life Sciences (India)

• Offers comprehensive API manufacturing, with a focus on regulatory compliance and supply chain reliability.

Quality and Regulatory Considerations

Sourcing Oteseconazole API requires strict validation of supplier credentials. Manufacturers must adhere to international GMP standards, ensure batch-to-batch consistency, and provide comprehensive documentation, including COAs, stability studies, and regulatory filings supporting global markets such as the US (FDA), EU (EMA), and Japan (PMDA).

Market Dynamics and Procurement Strategies

The supply of Oteseconazole API is influenced by factors such as raw material availability, manufacturing capacity, geopolitical stability, and regulatory landscapes. It is advisable for pharmaceutical companies to establish multi-sourcing strategies to mitigate risks associated with supply disruptions. Long-term partnerships with established API producers can facilitate stable supply, while due diligence remains crucial for emerging suppliers.

Emerging Trends in API Sourcing

• Vertical Integration: Companies are increasingly investing in in-house API synthesis or acquiring API suppliers to control quality and supply.
• Sustainable Manufacturing: Focus on green chemistry and environmentally friendly processes is gaining importance, impacting API sourcing decisions.
• Regulatory Harmonization: Manufacturers are aligning processes to meet multiple regulatory standards, making their APIs more attractive globally.

Conclusion

The supply chain for Oteseconazole API involves a mix of established international manufacturers, emerging suppliers, and CMOs. Pharmaceutical firms must prioritize supplier credibility, quality compliance, and regulatory compatibility when sourcing the API. Collaborative relationships with reputable API manufacturers and thorough vetting processes are essential to ensure uninterrupted supply, product quality, and regulatory adherence. Navigating this landscape effectively enhances manufacturing resilience and supports the development of effective topical antifungal formulations.

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Key Takeaways

• Prioritize established, GMP-compliant API suppliers with proven track records in antifungal APIs.
• Engage with reputable CMOs for scalable, regulatory-compliant production, especially during early clinical phases.
• Conduct comprehensive due diligence, including reviewing certifications, batch records, and stability data.
• Consider supply chain diversification to mitigate risks associated with geopolitical or raw material shortages.
• Stay abreast of trends like green chemistry and regulatory harmonization to inform sourcing strategies and maintain competitive advantage.

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FAQs

Q1: What are the primary quality standards for sourcing Oteseconazole API?
A1: The API must conform to pharmacopeial standards such as USP or Ph. Eur., with GMP compliance, validated manufacturing processes, and comprehensive documentation, including COA and stability data.

Q2: How can companies verify the credibility of an API supplier?
A2: Companies should review certifications (ISO, GMP, DMF), request audit reports, conduct site visits if possible, and assess historical supply reliability and regulatory compliance.

Q3: Is it better to source Oteseconazole API domestically or internationally?
A3: Both options have advantages; domestic sourcing offers easier communication and regulatory navigation, while international suppliers may provide cost benefits and diversified supply options. A strategic mix often yields optimal supply stability.

Q4: What are the key regulatory considerations for importing Oteseconazole API?
A4: Compliance with local regulatory requirements, proper documentation (COA, MSDS), validation of GMP standards, and adherence to import/export controls are critical for regulatory approval and market access.

Q5: What trends are shaping the future of API sourcing in the antifungal segment?
A5: Trends include increased emphasis on sustainable manufacturing practices, strategic vertical integration, digital transparency in supply chains, and harmonization of regulatory standards across regions.

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Sources

[1] European Pharmacopoeia. General Chapter on API standards.

[2] U.S. Pharmacopeia. USP Monograph for Imidazole Derivatives.

[3] Industry reports on antifungal API manufacturing, IQVIA 2022.

[4] Company websites and corporate disclosures of Zhejiang Hisun Pharmaceutical, Hangzhou Dayang Pharmaceutical, Xi'an Tianyin Pharmaceutical, Hetero Labs, among others.