Bulk Pharmaceutical API Sources for ERYTHROCIN STEARATE

Bulk Pharmaceutical API Sources for ERYTHROCIN STEARATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Finetech Industry Limited		FT-0625703
BOC Sciences		643-22-1
Yuhao Chemical		JZ4084
abcr GmbH		AB509260

Bulk Active Pharmaceutical Ingredient (API) Sources for: ERYTHROCIN STEARATE

Last updated: July 29, 2025

Introduction

Erythromycin stearate is a widely utilized esterified form of erythromycin, an essential macrolide antibiotic used to manage various bacterial infections. Its stability and oral bioavailability often make it preferable over other erythromycin salts. As a crucial component in pharmaceutical manufacturing, sourcing high-quality erythromycin stearate bulk API is paramount for compliance, efficacy, and safety. This article provides a comprehensive overview of global API suppliers, focusing on their capabilities, quality standards, regulatory compliance, and market positioning.

Understanding Erythromycin Stearate

Erythromycin stearate is synthesized through esterification of erythromycin with stearic acid. Its chemical stability enhances shelf-life and minimizes gastrointestinal upset associated with other erythromycin derivatives. The API's sourcing involves strict adherence to Good Manufacturing Practices (GMP), pharmacopeial standards such as USP, EP, or JP, and rigorous quality control measures. Proper sourcing ensures the therapeutic efficacy of finished pharmaceuticals and compliance with international regulatory standards.

Global API Suppliers for Erythromycin Stearate

1. Large-Scale Pharmaceutical API Manufacturers

a. Beijing Pharmaceutical Group (China)

• Profile: A leader in antibiotic manufacturing, Beijing Pharmaceutical Group ranks among the prominent API suppliers of erythromycin derivatives.
• Capabilities: Robust GMP facilities with annual production capacities exceeding several tons.
• Quality Standards: ISO 9001, GMP-certified; products conform to USP and other pharmacopeial standards.
• Market Focus: Supplying to multinational pharmaceutical companies and generic manufacturers globally.

b. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Profile: Renowned for developing and manufacturing high-quality antibiotics, including erythromycin stearate.
• Capabilities: Extensive R&D investments leading to reliable sourcing options.
• Quality Assurance: Strict quality control conforming to international standards; compliant with FDA and EMA regulations.
• Distribution: Global reach, especially in Asian and North American markets.

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

• Profile: Major supplier of macrolide antibiotics, with a significant focus on API production.
• Capabilities: State-of-the-art manufacturing facilities; scalable production lines.
• Regulatory Compliance: GMP-certified; API also meets specifications stated in major pharmacopeias.
• Market Presence: Supplies to both regional and international clients.

2. European API Producers

a. CordenPharma (Germany)

• Profile: A global provider of specialty APIs and advanced intermediates.
• Capabilities: Custom synthesis and large batch manufacturing, including erythromycin derivatives.
• Quality Standards: Compliant with ICH Q7 guidelines; GMP-certified.
• Distribution: Trusted by leading pharma and biotech firms for high-grade APIs.

b. PhytoPharma (Italy)

• Profile: Specializes in antibiotic APIs, with a focus on quality and consistency.
• Capabilities: Experience in large-scale production integrating complex esterification processes.
• Regulatory Compliance: Adheres to European pharmacopoeial standards; prepares for US DMF and EU CEP filings.

3. Indian API Manufacturers

a. Aurobindo Pharma Ltd.

• Profile: A prominent global supplier of generic APIs, including erythromycin derivatives.
• Capabilities: State-of-the-art manufacturing units capable of high-volume production.
• Quality Assurance: GMP, ISO 9001, and WHO-GMP certifies.
• Market Focus: Supplies to North America, Europe, and emerging markets.

b. Hetero Labs Limited

• Profile: Known for its extensive antibiotic manufacturing portfolio.
• Capabilities: ISO/GMP-compliant production facilities with significant R&D investments.
• Quality Standards: Meets international pharmacopeial standards; capable of custom synthesis.

4. Emerging and Specialty API Suppliers

a. Songjiang Pharmaceutical Co., Ltd. (China)

• Focus: Specializes in producing erythromycin salts and esters.
• Advantages: Competitive pricing combined with reliable quality standards.
• Delivery: Provides custom synthesis and sterile production options for APIs.

b. Anthem Biosciences (India)

• Focus: Emerging API manufacturer with a focus on niche antibiotics.
• Capabilities: Innovative esterification and purification capabilities.
• Standards: Complies with global GMP, ISO, and customer-specific standards.

Criteria for Selecting an API Supplier

• Regulatory Compliance: Ensure GMP certification, and cross-reference with FDA, EMA, and other relevant approvals.
• Quality Assurance: Verify analytical testing, in-process controls, and purity specifications.
• Manufacturing Capacity: Confirm ability to meet demand fluctuations.
• Reputation and Reliability: Assess track record, on-time delivery performance, and customer feedback.
• Pricing and Lead Times: Balance quality with competitive cost and efficient logistics.
• Regulatory Documentation: Availability of DMFs, CEPs, or Certificates of Suitability.

Regulatory and Quality Considerations

Sourcing erythromycin stearate requires adherence to strict regulatory standards. Manufacturers must provide comprehensive documentation, including:

• Certificates of Analysis (CoA)
• Certificates of Suitability
• Stability Data
• Manufacturing process validation reports
• Analytical method validation

These documents are vital for dossier submission, ensuring compliance with regulatory agencies, and avoiding supply chain disruptions.

Emerging Trends in API Sourcing

• Increased Focus on Quality: Rising regulatory scrutiny pushes companies to favor suppliers with proven GMP compliance and transparent quality systems.
• Supply Chain Diversification: To mitigate risks associated with geopolitical tensions and supply chain disruptions, companies source from multiple trusted suppliers across regions.
• Sustainability and Green Manufacturing: Suppliers investing in environmentally friendly processes and sustainable practices are gaining preference.
• Digital Integration: Enhanced traceability and quality control via digital platforms facilitate smoother procurement processes.

Conclusion

Securing reliable sources for erythromycin stearate API entails evaluating multiple factors ranging from regulatory compliance, manufacturing capacity, and quality standards to price competitiveness. Key suppliers originate from China, India, Europe, and emerging markets, each with unique strengths. The strategic selection of suppliers aligned with regulatory expectations and quality assurance practices can significantly influence the success of pharmaceutical development and commercialization endeavors.

Key Takeaways

• Global manufacturers of erythromycin stearate API provide diverse options; China and India dominate in production capacity and pricing.
• Prioritize suppliers with GMP certification, comprehensive regulatory documentation, and proven quality records.
• Due diligence, including audits and verification of certifications, minimizes regulatory and supply chain risks.
• Emerging trends emphasize sustainability, digital transparency, and supply chain diversification.
• Aligning sourcing strategies with regulatory requirements ensures smoother registration processes across markets.

FAQs

Q1: What are the primary regulatory standards for sourcing erythromycin stearate API?

A1: The primary standards include Good Manufacturing Practices (GMP), with APIs conforming to pharmacopeial specifications such as USP, EP, or JP. Regulatory compliance also requires certificates of analysis, DMFs, and stability data.

Q2: How does the quality of erythromycin stearate API impact pharmaceutical efficacy?

A2: High-quality API ensures consistent potency, purity, and stability, directly influencing drug efficacy and patient safety. Substandard quality can lead to therapeutic failure or adverse effects.

Q3: What risks are associated with sourcing APIs from emerging markets?

A3: Risks include variable quality standards, regulatory uncertainties, intellectual property concerns, and supply inconsistencies. Due diligence and audits mitigate these risks.

Q4: How can companies evaluate a supplier’s manufacturing capacity?

A4: Through documentation review (capacity reports, GMP certifications), on-site audits, and validation of batch records and production lead times.

Q5: Are there alternatives to traditional API suppliers for erythromycin stearate?

A5: Yes, some companies explore in-house synthesis, joint ventures with key suppliers, or advanced contract manufacturing organizations (CMOs) to diversify sources and ensure supply security.

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References

1. U.S. Pharmacopeia (USP). "Erythromycin and Salts." [Standard reference for pharmaceutical specifications]
2. European Pharmacopoeia (EP). "Erythromycin." [Official monograph details]
3. Market research reports on global antibiotic API production.
4. Manufacturer websites and regulatory filings.