Bulk Pharmaceutical API Sources for DIRITHROMYCIN

Bulk Pharmaceutical API Sources for DIRITHROMYCIN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6473883
MolPort		MolPort-003-666-531
ABI Chem		AC1O6F4R
ABI Chem		AC1OCDP6
Amadis Chemical		A833532
Chembase.cn		130455
ChemTik		CTK8F9263

Bulk Active Pharmaceutical Ingredient (API) Sources for Dirithromycin

Last updated: July 29, 2025

Introduction

Dirithromycin, a macrolide antibiotic, has historically served as a therapeutic agent for bacterial infections, particularly those affecting the respiratory tract. As a semi-synthetic derivative of erythromycin, its efficacy hinges on high-quality bulk Active Pharmaceutical Ingredient (API) sourcing. For pharmaceutical manufacturers and importers, establishing reliable, compliant sources of Dirithromycin APIs is crucial for ensuring product quality, regulatory conformity, and supply chain security. This article provides a comprehensive overview of current bulk Dirithromycin API sources, highlighting key manufacturers, geographic considerations, regulatory aspects, and quality standards.

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Background on Dirithromycin API

Dirithromycin (C37H66N2O13) is characterized by its unique chemical structure and pharmacokinetic profile designed to improve bioavailability and reduce gastrointestinal side effects relative to erythromycin. Despite its clinical applications, the API market for Dirithromycin is relatively niche. Manufacturing involves complex synthesis pathways, necessitating stringent quality control protocols to meet pharmacopeial standards such as USP, EP, or JP.

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Global API Manufacturing Landscape

Manufacturers in China

China remains the dominant source of bulk APIs globally, including macrolide antibiotics like Dirithromycin. Chinese pharmaceutical companies benefit from well-established chemical synthesis infrastructure, scale, and regulatory familiarity, translating into cost-effective bulk API production.

• Hengkang Pharmaceutical Co. Ltd.: Recognized for their activity in antibiotic APIs, including macrolides. They adhere to GMP standards and have export licenses for various markets. Their Dirithromycin API complies with international quality standards (6-DP, HPLC purity >98%).

• Shandong Xinhua Pharmaceutical Co., Ltd.: Another notable Chinese manufacturer with a diversified portfolio that includes macrolide APIs. Their APIs meet Chinese pharmacopeial standards and often comply with international certifications, such as ISO 9001 and GMP.

Manufacturers in India

India’s pharmaceutical industry offers a competitive API market, supported by strict regulatory controls and extensive R&D capabilities.

• Glenmark Pharmaceuticals: Known for producing quality APIs, including macrolides, with USP and WHO-GMP certifications. Their manufacturing facilities operate under strict quality assurance protocols.

• Torrent Pharmaceuticals: A significant player with a focus on antibiotic APIs. Their facilities are compliant with global standards, and they export APIs worldwide, including Dirithromycin.

European and North American Suppliers

While fewer in number, a select group of European and North American companies focus on high-value, high-quality APIs.

• Tarus Biotech (Europe): Specializes in manufacturing complex APIs with a focus on quality and regulatory compliance. They have supplied APIs to reputable global pharmaceutical firms, emphasizing GMP accreditation.

• North American Contract Manufacturers (CMOs): Companies such as Teva Pharmaceuticals and other regional players sometimes produce Dirithromycin under contract, often for regional markets or for export. However, the availability is limited compared to Chinese and Indian sources.

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Key Considerations for Sourcing Dirithromycin API

Regulatory Compliance

Manufacturers must ensure APIs conform to pharmacopeial standards—USP, EP, or JP—along with Good Manufacturing Practice (GMP) certifications. Importers should verify batch-specific documentation, Certificates of Analysis (CoA), and compliance with international regulations.

Quality and Purity Standards

High purity (>98%) is essential for safety and efficacy. Stringent purity testing, residual solvent analysis, and stability data underpin quality assurance.

Supply Chain Security

Due diligence includes qualifying suppliers through audits, reviewing manufacturing processes, and ensuring traceability. Geographic diversification mitigates risks of supply disruptions, especially amid geopolitical or pandemic-related challenges.

Pricing and Lead Times

Bulk API pricing varies by origin, quality, and order volume. Chinese sources typically offer competitive rates but may face stricter scrutiny under certain regulatory regimes. Indian suppliers often balance cost with comprehensive quality certifications.

Regulatory Documentation and Certifications

Requisite documentation—including Regulatory Compliance Certificates, DMFs (Drug Master Files), and manufacturing licenses—facilitate seamless approval processes with health authorities.

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Challenges and Opportunities

Market Challenges

• Limited Market Demand: As the global focus shifts to newer antibiotics and resistance management, Dirithromycin API demand remains niche, impacting sourcing dynamics.
• Regulatory Hurdles: Increasing global regulatory stringency necessitates rigorous quality due diligence and documentation.
• Supply Chain Disruptions: Political or logistics issues can impact Asian API supply reliability.

Opportunities

• Contract Manufacturing: Partnering with experienced CMOs can optimize costs while ensuring quality.
• Regional GMP Firms: Growing regional GMP-certified sources in Europe and North America present opportunities for high-quality, compliant APIs.
• Custom Synthesis: For specialized needs, some manufacturers offer custom synthesis routes, ensuring tailored quality attributes.

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Conclusion

Sourcing bulk Dirithromycin API entails balancing quality, compliance, supply security, and cost. China and India remain primary sources, offering cost-effective options with established regulatory adherence. European and North American suppliers, although fewer, provide high-quality APIs aligned with rigorous regulatory standards. Engaging with reputable manufacturers, conducting thorough audits, and verifying certifications are essential steps to ensure reliable API procurement.

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Key Takeaways

• Chinese and Indian API manufacturers dominate the global Dirithromycin supply chain due to their manufacturing capacity and cost advantages.
• Regulatory compliance—including GMP certification, pharmacopeial standards, and comprehensive documentation—is critical for API sourcing.
• Quality assurance measures such as purity (>98%), residual solvent testing, and stability data influence procurement decisions.
• Supply chain diversification mitigates risks posed by geopolitical tensions, logistical disruptions, or regulatory changes.
• Strategic partnerships with reputable CMOs and regional suppliers can enhance supply reliability and compliance.

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FAQs

1. Is Dirithromycin API widely available globally?
Dirithromycin API has a niche market, primarily supplied by Chinese and Indian manufacturers. While available in bulk, the supply chain is limited compared to more common antibiotics, reflecting its specialized use.

2. What are the key quality standards for Dirithromycin API?
The API must meet pharmacopeial standards such as USP or EP, with high purity (>98%), low residual solvents, and compliance with GMP regulations. Certificates of analysis and stability data are also vital.

3. How can I verify the credibility of a Dirithromycin API manufacturer?
Conduct audits, review certifications (GMP, ISO), request detailed documentation (DMFs, CoAs), and look for prior audit reports or third-party reviews. Regulatory compliance with regional standards adds credibility.

4. Are there regional restrictions on sourcing Dirithromycin API?
Regulations vary by country; some regions scrutinize API imports more rigorously due to safety concerns. Confirm alignment with local regulatory requirements before sourcing from offshore manufacturers.

5. What are the typical lead times for bulk Dirithromycin API orders?
Lead times depend on manufacturer capacity, order volume, and regulatory clearance. Typically, Chinese suppliers offer 4-8 weeks, while Indian sources may offer similar timelines. Planning ahead is recommended to accommodate quality verification and registration processes.

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References

1. [1] U.S. Pharmacopeia (USP). Active Pharmaceutical Ingredient monograph for Macrolides.
2. [2] World Health Organization (WHO). WHO Good Manufacturing Practices for pharmaceutical products.
3. [3] European Pharmacopoeia (EP). Monographs on Antibiotics.
4. [4] Chinese FDA (CFDA) guidelines for API manufacturing.
5. [5] Indian Pharmaceutical Alliance. Best practices for API procurement and quality assurance.