Bulk Pharmaceutical API Sources for AZASITE

Bulk Pharmaceutical API Sources for AZASITE

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		A2076
Molport		MolPort-002-507-426
Hangzhou APIChem Technology		AC-16014
AKos Consulting & Solutions		AKOS015895044
AstaTech, Inc.		N46072
Mcule		MCULE-8817893418

Bulk Active Pharmaceutical Ingredient (API) Sources for AZASITE

Last updated: July 28, 2025

Introduction

AZASITE®, a prescription ophthalmic solution containing azithromycin, is primarily used to treat bacterial conjunctivitis and blepharitis. Its efficacy hinges on the quality and consistency of its active pharmaceutical ingredient (API), azithromycin. As the global pharmaceutical landscape evolves, understanding the sources of bulk azithromycin APIs becomes crucial for manufacturers, pharma supply chain stakeholders, and regulatory authorities. This article explores the primary vendors, manufacturing bases, and quality considerations pertinent to sourcing azithromycin API for AZASITE® production.

Overview of Azithromycin API

Azithromycin, a macrolide antibiotic, belongs to the azalide subclass, offering broad-spectrum activity against Gram-positive and Gram-negative bacteria. Its complex chemical synthesis involves multiple steps, with strict quality controls to meet pharmacopeial standards. The API's sourcing landscape is characterized by a limited number of specialized manufacturers, predominantly situated in Asia due to cost advantages and manufacturing expertise.

Leading API Manufacturers for Azithromycin

1. Antibiotics from China

   China remains the dominant supplier of azithromycin API worldwide. Several manufacturers operate under strict regulatory oversight, producing high-quality API complying with international standards such as the USP, EP, and JP.

   • North China Pharmaceutical Group Corporation (NCPC)

     As a major player with integrated capabilities, NCPC supplies bulk azithromycin API to global markets. Their manufacturing facilities are GMP-certified, adhering to rigorous quality assurance protocols.

   • Qingdao Century Am Cell Co., Ltd.

     Specializing in antibiotics, this company has established a significant presence in the azithromycin API supply chain. Their products are exported globally, with quality certifications ensuring compliance with pharmaceutical standards.

   • Harbin Pharmaceutical Group (HPG)

     HPG’s APIs are known for high purity and consistent batch-to-batch performance. Their manufacturing facilities are certified by Chinese authorities and frequently inspected by international regulators.

2. Indian API Manufacturers

   India has emerged as a competitive hub for API production, including azithromycin, driven by the country's robust pharmaceutical sector.

   • Aarti Drugs Ltd.

     Aarti Drugs offers azithromycin API with certifications aligned to global standards, catering to both generic and branded formulations.

   • Glenmark Pharmaceuticals

     With facilities in India and compliance with global GMP standards, Glenmark supplies azithromycin API tailored for international markets.

   • Biochem Pharmaceutical Industries

     Known for its focus on antibiotics, Biochem provides high-quality azithromycin with strict adherence to quality assurance protocols.

3. Manufacturing in Other Regions

   While Asia dominates, smaller manufacturers in Europe and North America produce azithromycin API, typically for niche or specialty markets, often under stringent regulatory oversight. However, their market share remains limited due to higher production costs.

Quality Standards and Regulatory Considerations

All sources must meet core pharmacopeial standards, including USP <797>, EP 2.4.20, and JP guidelines, ensuring microbiological purity, potency, and stability. Validation reports, stability data, and Certificates of Analysis (CoA) are essential documents for procurement and regulatory submission.

Manufacturers often undergo audits by procurement companies or regulatory bodies, with Genomic DNA testing and residual solvent analysis forming part of quality assurance protocols. Suppliers compliant with ICH Q7 Good Manufacturing Practice (GMP) standards gain preferential consideration.

Supply Chain Dynamics

The API supply chain's complexity influences reliability, cost, and quality. Factors affecting sourcing include:

• Regulatory approvals and documentation: Ensuring API suppliers have approval from agencies such as the FDA, EMA, or TGA is crucial for market access.

• Manufacturing capacity and lead times: COVID-19 pandemic disruptions underscored vulnerabilities, making diversified sourcing strategies advisable.

• Price considerations: While cheaper Asian APIs are prevalent, potential trade disputes or non-compliance issues could affect procurement.

• Intellectual property and patent status: Although azithromycin patents have expired in many jurisdictions, suppliers should ensure their APIs are free from patent infringement concerns.

Emerging Trends and Innovations

Emerging manufacturing technologies aim to improve API purity and process efficiency, including continuous manufacturing and green chemistry approaches. Such innovations promise to enhance the sustainability and scalability of azithromycin production, potentially expanding available sources.

Conclusion

The primary bulk API sources for AZASITE®'s azithromycin are concentrated in China and India, with a handful of manufacturers offering compliant, high-quality products. Due diligence, quality compliance, and supply chain resilience are critical considerations when selecting API suppliers. As market dynamics evolve, emerging manufacturers adopting innovative and sustainable production methods may further diversify the sourcing landscape.

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Key Takeaways

• Dominant API Producers: Chinese and Indian manufacturers lead in azithromycin API supply, with reputable firms offering compliance with international quality standards.

• Quality Assurance: Ensuring API suppliers have GMP certification, comprehensive documentation, and regulatory approvals is essential for AZASITE® manufacturing.

• Supply Chain Resilience: Diversifying sourcing pathways mitigates risks from geopolitical, logistical, or regulatory disruptions.

• Regulatory Vigilance: Continuous monitoring of compliance status and certifications safeguards product quality and market access.

• Innovation Potential: Technological advances may expand API sources in the future, potentially improving sustainability and cost-efficiency.

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FAQs

1. What are the main regions producing azithromycin API globally?
   Primarily China's and India's APIs dominate the global market, with additional production in Europe and North America serving niche needs.

2. How do quality standards impact API sourcing decisions?
   Suppliers must meet pharmacopeial standards and be GMP-certified to ensure API purity, potency, and safety, which directly influence product efficacy and regulatory approval.

3. Are there risks associated with sourcing azithromycin API from Asian manufacturers?
   Potential risks include supply disruptions, quality variability, regulatory non-compliance, and geopolitical factors. Due diligence and diversified sourcing can mitigate these risks.

4. What role do regulatory agencies play in API sourcing?
   Agencies like the FDA, EMA, and PMDA validate supplier compliance through inspections and certification, influencing procurement decisions and market authorization.

5. Can innovative manufacturing techniques impact API availability?
   Yes, advances such as continuous manufacturing and greener synthesis processes can improve production efficiency, reduce costs, and potentially increase supply stability.

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References

[1] U.S. Pharmacopeia. "USP <797>: Pharmaceutical Compounding—Sterile Preparations."

[2] European Pharmacopoeia. "Chapter 2.4.20: Bulk Pharmaceutical Ingredients."

[3] International Conference on Harmonisation. "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients."

[4] IQVIA. “Global API Market Insights," 2022.

[5] Chinese Pharmacopoeia, 2020 Edition.