Bulk Pharmaceutical API Sources for BIAXIN XL

Bulk Pharmaceutical API Sources for BIAXIN XL

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		C2220
Molport		MolPort-002-507-425
Amadis Chemical		A840042
AKos Consulting & Solutions		AKOS015894242
Mcule		MCULE-7168853332

Bulk Active Pharmaceutical Ingredient (API) Sources for BIAXIN XL

Last updated: July 30, 2025

Introduction

Biaxin XL, an extended-release formulation of clarithromycin, is a macrolide antibiotic indicated for treating respiratory tract infections, skin infections, and certain forms of Helicobacter pylori-related ulcers. As with all pharmaceutical products, the consistent quality and reliable supply chain of its Active Pharmaceutical Ingredient (API), clarithromycin, are vital to manufacturing efficacy and regulatory compliance.

This article provides a comprehensive analysis of primary sources for bulk clarithromycin API suitable for Biaxin XL production. It highlights key suppliers, manufacturing considerations, and industry trends crucial for pharmaceutical companies seeking strategic procurement options.

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Overview of Clarithromycin API Manufacturing

Clarithromycin, a semi-synthetic macrolide antibiotic derived from erythromycin, is synthesized via fermentation followed by chemical modification. The API's manufacturing process demands complex fermentation conditions, rigorous purification, and strict adherence to Good Manufacturing Practice (GMP) standards.

The global API market for clarithromycin is predominantly concentrated among major pharmaceutical manufacturers with established fermentation and synthesis capabilities. Ensuring a stable supply chain involves assessing supplier quality certifications, production capacity, and compliance with international regulatory standards like the U.S. FDA, EMA, and PIC/S.

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Major Suppliers of Clarithromycin API for Biaxin XL

1. Aurobindo Pharma

Overview: India-based Aurobindo Pharma is a significant global player in generic pharmaceuticals, with extensive API manufacturing capabilities, including clarithromycin.

Strengths:

• GMP-certified manufacturing plants approved by international regulators.
• Proven track record in supplying high-quality APIs.
• Cost-effective production with substantial capacity to meet global demands.

Supply Chain Role: Aurobindo supplies clarithromycin API to various multinational pharmaceutical companies for formulations including Biaxin XL.

Certifications: USFDA, EMA, ISO.

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2. Mylan (Viatris)

Overview: As a part of Viatris, Mylan maintains multiple API manufacturing facilities producing clarithromycin.

Strengths:

• Extensive portfolio of antibiotics with high production standards.
• Strong regulatory compliance and quality assurance processes.
• Strategic geographic positioning allowing flexible supply logistics.

Supply Chain Role: Mylan’s clarithromycin API is used both domestically and exported globally.

Certifications: USFDA, EMA, ISO.

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3. Solara Active Pharma Sciences

Overview: Based in India, Solara specializes in antibiotic APIs, including clarithromycin.

Strengths:

• Dedicated R&D for API synthesis and process optimization.
• GMP-compliant facilities with robust quality management systems.
• Focused on export markets with strict regulatory adherence.

Supply Chain Role: Offers bulk clarithromycin API to various generics manufacturers producing Biaxin XL.

Certifications: USFDA, EU-GMP.

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4. Zhejiang Hisun Pharmaceutical Co., Ltd.

Overview: Chinese pharmaceutical firm with significant API manufacturing operations, including clarithromycin.

Strengths:

• Large-scale fermentation and chemical synthesis facilities.
• Competitive pricing due to regional manufacturing efficiencies.
• Growing regulatory acceptance in international markets.

Supply Chain Role: Supplies clarithromycin API to both local and international formulations.

Certifications: CFDA (now NMPA), GMP.

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5. Fermentation and Synthesis Contract Manufacturers

Beyond primary API producers, contract manufacturing organizations (CMOs) like Catalent, Fujifilm Diosynth, and Lonza provide custom API synthesis and fermentation services. These organizations enable pharmaceutical companies to scale manufacturing or develop tailored formulations.

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Emerging Trends in API Sourcing for Clarithromycin

Global Supply Chain Realignment

Recent geopolitical shifts, COVID-19 disruptions, and regulatory tightenings have prompted pharmaceutical firms to diversify their API sources. Dependence on a limited number of suppliers has given way to multi-source procurement strategies, emphasizing regional manufacturing hubs for reduced risk.

Regulatory and Quality Assurance

Manufacturers seeking to supply Biaxin XL internationally must ensure API suppliers possess rigorous regulatory approvals, GMP certifications, and comprehensive quality control documentation. Select suppliers with robust batch consistency and proven compliance histories to mitigate regulatory risks.

Cost and Capacity Considerations

While India and China remain dominant due to cost advantages, emerging players tend to offer competitive pricing while adhering to regulatory standards. Capacity expansion by suppliers like Aurobindo and Zhejiang Hisun indicates an ongoing effort to meet increasing global demand.

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Regulatory and Quality Assurance Implications

API quality directly influences the safety and efficacy of Biaxin XL. Suppliers must furnish certificates of analysis (CoA), stability data, and compliance attestations aligned with pharmacopeial standards (USP, EP, JP). Due diligence, including audits and site inspections, remains essential in selecting reliable API vendors.

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Conclusion

Sourcing clarithromycin API for Biaxin XL involves a strategic evaluation of major global suppliers, manufacturing capabilities, regulatory compliance, and supply chain resilience. Aurobindo Pharma and Mylan stand out as leading providers with established international reputations. Chinese and Indian manufacturers like Zhejiang Hisun and Solara offer cost-effective alternatives, aligning with industry trends toward regional diversification.

Ensuring high-quality, compliant API sourcing will secure continuous production, meet regulatory standards, and optimize cost efficiency for pharmaceutical companies producing Biaxin XL.

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Key Takeaways

• Strategic supplier diversification reduces risk amid global supply chain disruptions.
• Major Indian and Chinese API producers, including Aurobindo and Zhejiang Hisun, dominate the clarithromycin market.
• Regulatory compliance and GMP certification are non-negotiable factors in API sourcing decisions.
• Contract manufacturing organizations offer flexible options for capacity expansion and process customization.
• Staying abreast of regional regulatory changes and industry trends is essential for sourcing stability.

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FAQs

1. What are the primary regions producing clarithromycin API?
India and China are the main regions, with significant manufacturing capacities in both nations, supported by their cost advantages and regulatory harmonization efforts.

2. How can manufacturers ensure API quality compliance?
By selecting suppliers with valid GMP certifications, comprehensive quality documentation, and demonstrated compliance with international pharmacopeias and regulatory agencies.

3. Are regional suppliers suitable for U.S. and European markets?
Yes, provided they meet U.S. FDA, EMA, or equivalent rigorous standards, and possess necessary certifications and documentation.

4. What role do contract manufacturing organizations (CMOs) play?
CMOs offer tailored API synthesis, capacity scalability, and process optimization, aiding companies to meet specific formulation needs or manage supply disruptions.

5. How might geopolitical factors influence API sourcing for clarithromycin?
Trade policies, tariffs, and regional regulations can impact supply chain stability, making diversification and regional sourcing critical to risk mitigation.

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Sources:

1. [1] Market Analysis on Clarithromycin API Global Supply, IMS Health, 2022.
2. [2] GMP Certification Records, USFDA, EMA.
3. [3] Company websites and product catalogs: Aurobindo, Mylan, Solara, Zhejiang Hisun.
4. [4] Industry reports on antibiotic API manufacturing trends, Global Data, 2023.