Suppliers and packagers for generic pharmaceutical drug: CLARITHROMYCIN

CLARITHROMYCIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	CLARITHROMYCIN	clarithromycin	FOR SUSPENSION;ORAL	065283	ANDA	Sandoz Inc	0781-6022-46	100 mL in 1 BOTTLE (0781-6022-46)	2007-09-04
Sandoz	CLARITHROMYCIN	clarithromycin	FOR SUSPENSION;ORAL	065283	ANDA	Sandoz Inc	0781-6022-52	50 mL in 1 BOTTLE (0781-6022-52)	2007-09-04
Sandoz	CLARITHROMYCIN	clarithromycin	FOR SUSPENSION;ORAL	065283	ANDA	Sandoz Inc	0781-6023-46	100 mL in 1 BOTTLE (0781-6023-46)	2007-09-04
Sandoz	CLARITHROMYCIN	clarithromycin	FOR SUSPENSION;ORAL	065283	ANDA	Sandoz Inc	0781-6023-52	50 mL in 1 BOTTLE (0781-6023-52)	2007-09-04

Suppliers for the Pharmaceutical Drug: Clarithromycin

Last updated: July 30, 2025

Introduction

Clarithromycin is a macrolide antibiotic widely used to treat respiratory infections, skin infections, Helicobacter pylori-associated ulcers, and other bacterial diseases. As a critical component within the antimicrobial pipeline, clarithromycin's global supply chain features a complex network of manufacturing entities, raw material providers, and distribution channels. Understanding the current supplier landscape is vital for pharmaceutical companies, healthcare providers, and policymakers aiming to ensure reliable access, price stability, and quality assurance.

Global Manufacturing Landscape

Major Producers of Clarithromycin

The production of clarithromycin involves sophisticated synthetic organic chemistry processes, primarily sourced from select, high-capacity pharmaceutical manufacturers. Leading suppliers are predominantly based in countries with robust pharmaceutical sectors such as China, India, and European nations.

1. Chinese Pharmaceutical Giants

Chinese pharmaceutical companies have become dominant producers of generic antibiotics, including clarithromycin. Entities like Shanghai Pharmaceutical and Shenzhen Chipscreen Bioscience are key players, leveraging extensive R&D and manufacturing infrastructure. These companies supply both the domestic market and export large volumes globally, benefiting from lower production costs and government support for API (Active Pharmaceutical Ingredient) manufacturing.

2. Indian API Manufacturers

India's pharmaceutical industry is renowned for its robust generic drug manufacturing capabilities. Companies such as Aurobindo Pharma, Cipla, and Teva Pharmaceuticals India are major suppliers of clarithromycin APIs. These firms are certified by international regulatory agencies like the US FDA and the European Medicines Agency (EMA), ensuring compliance with stringent quality standards.

3. European and North American Suppliers

While less prominent in bulk API manufacturing, European companies such as Sanofi (which historically marketed branded clarithromycin formulations) and North American entities often operate at higher regulatory standards and contribute through licensed manufacturing agreements and contract manufacturing organizations (CMOs). These suppliers tend to focus on finished dosage forms but may also supply APIs under strict quality controls.

Raw Material and API Supply Chain Features

Chemicals and Intermediates Sources

The synthesis of clarithromycin involves several specialized chemical intermediates, often sourced from a select number of chemical suppliers globally. These raw materials include building blocks like erythromycin derivatives, methylating agents, and specific solvents.

Major supplies of chemical intermediates are provided by global chemical companies like BASF, Lanxess, and Dongwoo Fine-Chem, which operate extensive chemical plants with high-quality control standards. The purity and consistency of these intermediates are critical, impacting the overall quality of the final API.

Regulatory and Quality Considerations

Most clarithromycin suppliers are required to comply with international quality standards, including cGMP (current Good Manufacturing Practices), and must pass audits by global regulatory agencies. Popular compliant suppliers include those with approvals from the US FDA or EMA, which facilitate their export and acceptance in global markets.

The supply chain's integrity depends significantly on maintaining strict quality control processes, including robust quality assurance, stability testing, and traceability measures, to prevent contamination or substandard batches entering the market.

Market Dynamics and Supply Risks

The clarithromycin supply chain has experienced volatility in recent years, driven by factors such as:

• Regulatory tightening: Stricter inspection standards affecting manufacturing sites in China and India.
• Environmental and political factors: Trade tensions and export restrictions affecting certain regions.
• Demand fluctuations: The COVID-19 pandemic temporarily disrupted some supply lines, emphasizing the importance of diversified sourcing.

Supply chain vulnerabilities highlight the importance of geographic diversification, robust vendor qualification processes, and strategic stockpiling for pharmaceutical companies.

Future Supply Trends and Key Players

Emerging trends include increased automation in API manufacturing, new entrants from Southeast Asia, and the development of sustainable, environmentally friendly production methods.

Key players vital to the current and future landscape include:

• Shanghai Fosun Pharmaceutical: A prominent supplier involved in API production and formulation.
• Aurobindo Pharma: Leading Indian API supplier with multiple manufacturing sites.
• Teva Pharmaceutical Industries Ltd.: A global generic medicines leader with clarithromycin API manufacturing.

Conclusion

The supply of clarithromycin hinges on a well-distributed network predominantly comprised of Chinese and Indian manufacturers, supported by European and North American enterprises. Ensuring stability in this complex supply chain requires ongoing monitoring of regulatory compliance, geopolitical developments, and manufacturing capacity. As demand persists for this essential antibiotic, stakeholders must prioritize sourcing strategies, quality assurance, and diversification to mitigate risks.

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Key Takeaways

• The primary global suppliers of clarithromycin are based in China, India, and Europe, with a significant share produced in Chinese and Indian facilities.
• Regulatory compliance, particularly adherence to cGMP and certifications from FDA or EMA, is critical for quality assurance.
• Raw material sourcing from chemical giants like BASF influences API quality and availability.
• Market volatility has underscored the importance of supply chain diversification and strategic inventory management.
• Emerging manufacturing technologies and new entrants are poised to influence future supply dynamics.

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FAQs

1. Who are the top international suppliers of clarithromycin API?
Major suppliers include Chinese companies like Shanghai Fosun Pharmaceutical, Indian firms such as Aurobindo Pharma and Cipla, and European companies with regulatory-approved manufacturing facilities like Sanofi.

2. What are the primary raw materials used in clarithromycin synthesis?
They include erythromycin derivatives, methylating agents, and specialized chemical intermediates sourced from chemical companies like BASF and Lanxess.

3. How is quality assurance maintained among clarithromycin suppliers?
Suppliers adhere to cGMP standards, undergo regular audits by regulatory agencies, and maintain traceability and stability testing protocols to ensure product integrity.

4. What are the risks associated with clarithromycin supply chain disruptions?
Risks include regulatory changes, political instability, environmental restrictions, and global health crises like COVID-19, which can lead to shortages or quality issues.

5. Are there new entrants or alternative suppliers emerging in the clarithromycin market?
Yes, emerging manufacturers from Southeast Asia and new technology adopters are gradually increasing market competition and supply resilience.

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References

1. [1] Pharmequip. “Global Clarithromycin API Market Trends.” 2022.
2. [2] U.S. Food and Drug Administration. “API Supplier Inspection Reports.” 2023.
3. [3] Market Research Future. “Pharmaceutical APIs Market Analysis.” 2022.
4. [4] Chemical & Pharmaceutical Industry Reports. “Intermediates and API Raw Material Supply Chains.” 2021.
5. [5] World Health Organization. “Antimicrobial Supply Chain Resilience.” 2022.