Bulk Pharmaceutical API Sources for ERY-TAB

Bulk Pharmaceutical API Sources for ERY-TAB

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		E0774_SIAL
Sigma-Aldrich		E5389_SIGMA
Sigma-Aldrich		E6376_SIAL
Sigma-Aldrich		E7904_SIGMA
TCI (Tokyo Chemical Industry)		E0751
Molport		MolPort-002-507-378
Hangzhou APIChem Technology		AC-12744

Bulk Active Pharmaceutical Ingredient (API) Sources for ERY-TAB

Last updated: July 30, 2025

Introduction

Erythromycin ethylsuccinate, marketed as ERY-TAB, is a broad-spectrum macrolide antibiotic used primarily for respiratory infections, skin infections, and certain sexually transmitted diseases. As a key ingredient in ERY-TAB formulations, the quality, sourcing, and regulation of the Active Pharmaceutical Ingredient (API) are paramount in ensuring drug efficacy, safety, and compliance with pharmaceutical standards. This analysis explores primary sources for bulk ERY-TAB API, examining global suppliers, manufacturing considerations, and regulatory landscapes.

Understanding ERY-TAB and Its API

Erythromycin Ethylsuccinate is a chemically modified form of erythromycin designed for improved stability, bioavailability, and patient tolerability when administered orally as a coated or uncoated tablet. The API, erythromycin ethylsuccinate, is synthesized via complex fermentation and chemical processes, requiring high-quality raw materials and stringent quality control measures.

Global API Suppliers for ERY-TAB

1. Chinese Manufacturers

China remains the predominant global supplier of erythromycin and its derivatives, including ERY-TAB API. Major Chinese pharmaceutical firms have established extensive fermentation and chemical synthesis facilities capable of producing high-purity erythromycin ethylsuccinate at scale.

• Key Players:

  • North China Pharmaceutical Group Corporation (NCPC): A notable producer, NCPC has extensive experience in macrolide manufacturing, adhering to cGMP standards, and exporting globally. (Source: [1])

  • Tianjin Innovax Biotech Co., Ltd.: Specializes in fermentation-derived antibiotics and has capabilities for erythromycin derivatives.

  • Qingdao Guolin Pharmaceutical Co., Ltd.: Offers erythromycin API suitable for ERY-TAB synthesis, with certifications complying with international standards.

• Regulatory Status: Chinese companies increasingly register their APIs with agencies like the Chinese NMPA and seek prequalification from WHO or EMA approval to boost international acceptance.

2. Indian Manufacturers

India boasts a robust pharmaceutical manufacturing sector, producing erythromycin API used predominantly for domestic and export markets. The Indian industry emphasizes cost competitiveness and quality compliance.

• Prominent Suppliers:

  • Micro Labs Ltd.: Produces erythromycin API, with ISO and cGMP certifications supporting exportability.

  • Alkem Laboratories: Registered for erythromycin API supplying formulations including ERY-TAB.

• Market Dynamics: Indian APIs are often cost-effective options, with several manufacturers achieving certifications such as WHO-GMP, USFDA, and EDQM compliance to meet international demand.

3. European and North American Suppliers

While European and North American producers constitute a smaller segment relative to China and India, they supply high-quality erythromycin APIs, often preferred for their stringent regulatory oversight.

• European Suppliers:

  • EVONIK Industries: Offers pharmaceutical-grade erythromycin, focusing on high purity with strict adherence to EU GMP standards.

• North American Suppliers:

  • Pharmaceutical Manufacturing Facilities: Some North American firms produce erythromycin APIs, often targeting niche markets or custom synthesis, although they tend to be more expensive.

• Certification & Compliance: These suppliers generally hold regulatory approvals such as FDA and EMA registrations, important for high-stakes markets requiring stringent validation.

4. Contract Manufacturing Organisations (CMOs)

Several CMOs globally specialize in macrolide APIs, providing custom synthesis and bulk API production for licensors and pharmaceutical companies.

• Notable CMOs:

  • Fujifilm Diosynth Biotechnology: Offers fermentation-based erythromycin API production, maintaining FDA and EMA compliance.

  • Novartis Phase-Appropriate Contracts: Engage in hybrid manufacturing, combining chemical synthesis with fermentation to optimize yield and cost-efficiency.

Manufacturing and Quality Considerations

The API’s efficacy hinges on strict process controls, fermentation parameters, raw material quality, and impurity management. Manufacturers follow high standards, including:

• GMP Compliance: Ensuring consistency and safety for pharmaceutical applications.

• Purity Standards: APIs with ≥99% purity are standard for ERY-TAB, with certified residual solvents, heavy metals, and residual fermentatives within limits.

• Impurity Profile: Minimization of erythromycin degradation products and related impurities is vital, especially to prevent adverse reactions or efficacy reduction.

Regulatory Landscape and Certification

Sourcing API for ERY-TAB demands compliance with regional and international regulations:

• FDA (USA): Requires cGMP certification, Certificate of Analysis (CoA), and in some cases, Drug Master Files (DMFs).

• EMA (Europe): Similar to FDA, EMA emphasizes GMP and batch-specific data.

• WHO Prequalification: Particularly significant for suppliers aiming to provide APIs to developing countries or through WHO procurement channels.

• USP/EP/JP Standards: Many APIs conform to Pharmacopoeial standards, facilitating high-quality sourcing.

Supply Chain and Market Trends

The global market for erythromycin API, including ERY-TAB, is experiencing dynamic shifts driven by:

• Cost pressures: Indian and Chinese suppliers predominantly serve these markets due to competitive pricing.

• Quality assurance: European and North American suppliers cater to markets with higher regulatory scrutiny.

• Supply security: Geopolitical factors, export policies, and trade disputes influence API sourcing strategies.

• Environmental considerations: Manufacturers increasingly adopt greener fermentation and chemical processes to reduce environmental impact.

Challenges and Opportunities

• Regulatory hurdles: Ensuring ongoing compliance and documentation can be complex for emerging suppliers.

• Quality consistency: Maintaining high purity and impurity profiles across batches demands rigorous process control.

• Intellectual property: While erythromycin APIs are off-patent, proprietary process innovations may influence third-party sourcing.

• Supply chain resilience: Diversifying sources mitigates risks associated with geopolitical or pandemic-related disruptions.

Conclusion

The bulk supply of erythromycin ethylsuccinate API for ERY-TAB is predominantly sourced from China and India, supported by high-capacity fermentation and chemical synthesis infrastructure. European and North American suppliers focus on premium quality with strict regulatory adherence. The choice of supplier depends on regulatory requirements, cost considerations, and quality standards—critical factors for pharmaceutical companies aiming to ensure uninterrupted production and compliance.

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Key Takeaways

• Chinese and Indian manufacturers dominate the bulk ERY-TAB API market due to cost efficiency and manufacturing volume.

• European and North American suppliers offer high-purity APIs with advanced regulatory compliance, suitable for stringent markets.

• Maintaining cGMP standards, purity, and impurity profiles is essential for API sourcing, affecting drug efficacy and safety.

• Regulatory certifications such as WHO prequalification, USFDA, EMA, and Pharmacopoeial compliance are critical in selecting reliable suppliers.

• A diversified supply chain enhances resilience against geopolitical, environmental, and market disruptions.

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FAQs

1. What are the main criteria for selecting an API supplier for ERY-TAB?
Supply chain stability, manufacturing quality (GMP compliance), API purity (≥99%), impurity profiles, regulatory certifications, and cost-effectiveness.

2. Are Chinese and Indian erythromycin APIs interchangeable for ERY-TAB manufacturing?
Yes, provided they meet the same quality standards and regulatory requirements; however, validation processes must confirm equivalency.

3. What regulatory considerations are essential for sourcing ERY-TAB API globally?
Compliance with cGMP, submission of Certificates of Analysis, adherence to Pharmacopoeial standards, and registration with agencies like the FDA, EMA, or WHO.

4. How does environmental sustainability influence API sourcing decisions?
Manufacturers adopting greener fermentation and chemical processes are increasingly preferred, aligning with global environmental standards and corporate responsibility.

5. What future trends are expected in the ERY-TAB API supply market?
Increasing automation, stricter regulatory oversight, expansion of sourcing from certified suppliers, and growth of biosynthetic or hybrid manufacturing methods.

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References

1. [1] Chinese pharmaceutical industry reports and market analyses, 2022.