Suppliers and packagers for generic pharmaceutical drug: azithromycin

azithromycin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666	ANDA	Amneal Pharmaceuticals LLC	65162-708-83	1 BOTTLE in 1 CARTON (65162-708-83) / 15 mL in 1 BOTTLE	2018-07-23
Amneal	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666	ANDA	Amneal Pharmaceuticals LLC	65162-758-83	1 BOTTLE in 1 CARTON (65162-758-83) / 15 mL in 1 BOTTLE	2018-07-23
Amneal	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666	ANDA	Amneal Pharmaceuticals LLC	65162-759-39	1 BOTTLE in 1 CARTON (65162-759-39) / 22.5 mL in 1 BOTTLE	2018-07-23
Amneal	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666	ANDA	Amneal Pharmaceuticals LLC	65162-760-84	1 BOTTLE in 1 CARTON (65162-760-84) / 30 mL in 1 BOTTLE	2018-07-23

Suppliers for the Pharmaceutical Drug: Azithromycin

Last updated: July 27, 2025

Introduction

Azithromycin, a macrolide antibiotic first introduced in the late 1980s, has become a cornerstone treatment for bacterial infections such as respiratory tract infections, skin infections, and certain sexually transmitted diseases. Its broad-spectrum efficacy, favorable pharmacokinetics, and safety profile have maintained its high demand globally. Consequently, sourcing reliable suppliers is pivotal for pharmaceutical manufacturers, healthcare providers, and distributors aiming to ensure uninterrupted supply chains. This article provides a comprehensive overview of key suppliers for azithromycin, detailing major manufacturers, their manufacturing capabilities, and factors influencing procurement choices.

Global Manufacturing Landscape of Azithromycin

The production of azithromycin involves sophisticated chemical synthesis and sterile manufacturing processes, often undertaken by large pharmaceutical firms or specialized contract manufacturers. Leading firms in the azithromycin supply chain are primarily situated in regions with robust pharmaceutical sectors such as India, China, Europe, and North America.

Major Manufacturers of Azithromycin

1. Pfizer Inc.

As the originator of azithromycin under the brand name Zithromax (or Zitromax outside North America), Pfizer remains a key player in manufacturing and distributing azithromycin globally. Pfizer owns the original patents and extensive global manufacturing infrastructure, including raw material sourcing, API production, and finished dosage form assembly. Pfizer's manufacturing facilities are compliant with international standards like FDA, EMA, and WHO cGMP guidelines, ensuring reliable quality.

2. Teva Pharmaceutical Industries Ltd.

Teva, one of the world’s largest generic pharmaceutical manufacturers, produces azithromycin API and finished products, primarily targeting markets outside North America. The company's extensive global supply chain leverages large-scale manufacturing facilities in Israel, India, and Europe. Teva's products undergo rigorous validation to meet international quality standards.

3. Sandoz (Novartis AG)

Sandoz, the generics division of Novartis, supplies azithromycin API and finished formulations in various markets, including Europe, Latin America, and Asia. Their manufacturing facilities are certified by multiple regulatory agencies, and they emphasize sustainable production and supply continuity.

4. Lumicera (part of Lupin Limited)

Lupin Limited, an Indian pharmaceutical company, is a significant producer of azithromycin API and formulations. Their robust manufacturing capabilities are situated in India, leveraging low-cost, high-volume operations compliant with global quality standards. Lupin supplies both generic azithromycin and complex formulation variants.

5. Aspen Pharmacare

Based in South Africa, Aspen supplies azithromycin to African markets and some parts of South America. Their production facilities operate under strict quality controls, often targeting emerging markets where the demand for affordable antibiotics is high.

Contract Manufacturing Organizations (CMOs)

Beyond direct manufacturers, numerous CMOs offer custom synthesis, API manufacturing, and formulation services for azithromycin. These companies often serve as supply chain partners, enabling flexibility and scalability for pharmaceutical firms. Notable CMOs include Catalent, Boehringer Ingelheim, and Sai Life Sciences.

Key Factors Affecting Supplier Selection

1. Regulatory Compliance and Quality Assurance

Regulatory approvals (FDA, EMA, WHO GMP) are non-negotiable. Suppliers with proven compliance ensure product safety and efficacy, critical for avoiding delays or rejections during registration processes.

2. Production Capacity & Lead Times

High-volume demand necessitates suppliers with scalable production capabilities. Lead times, from API synthesis to delivery, influence inventory planning and responsiveness to market shifts.

3. Geographical Considerations

Proximity to markets reduces logistics costs and supply chain disruptions. Suppliers in emerging markets like India and China are often preferred for cost advantages, whereas developed markets may prioritize established regulatory compliance and quality controls.

4. Cost & Pricing

Price competitiveness influences procurement strategy, especially for large-volume purchases. However, cost considerations must be balanced against quality and supply reliability.

5. Intellectual Property & Patent Status

Although azithromycin patents have largely expired worldwide, certain formulations or combinations might still be patent-protected in specific jurisdictions, affecting supplier eligibility.

Emerging Trends Impacting Azithromycin Suppliers

1. Supply Chain Diversification

Global disruptions, as seen during the COVID-19 pandemic, highlight the importance of diversified sourcing strategies. Companies increasingly engage multiple suppliers to mitigate risks.

2. Quality Automation & Digitalization

Enhanced quality control through automation and digital traceability boosts confidence in sourcing from international suppliers.

3. Focus on Sustainability

Environmental considerations lead suppliers to adopt greener manufacturing processes, influencing procurement preferences.

4. Price Pressures & Market Competition

The entry of generic manufacturers has intensified price competition, impacting profit margins and supply dynamics.

Regulatory & Ethical Considerations

All suppliers targeting global markets must adhere to stringent regulatory standards and ethical manufacturing practices. Ensuring suppliers meet WHO prequalification, EMA, or FDA standards is vital, especially when supplying to low- and middle-income countries.

Conclusion

The global azithromycin supply chain is characterized by a mix of established pharmaceutical corporations, regional manufacturers, and contract manufacturers operating across diverse geographies. Pfizer remains a dominant force due to its patent ownership and manufacturing infrastructure, though Indian firms such as Lupin and global players like Teva are major contenders in generics markets. For stakeholders, prioritizing suppliers with proven regulatory compliance, scalable capacity, cost competitiveness, and supply reliability is essential in maintaining a resilient procurement strategy amid market and geopolitical uncertainties.

Key Takeaways

• Pfizer continues to be a primary supplier through its original formulations, with significant manufacturing capacity worldwide.
• Indian companies like Lupin, and Chinese manufacturers, are vital for generic azithromycin supply at competitive prices.
• Regulatory compliance, particularly WHO GMP certification, is critical when selecting suppliers for global distribution.
• Supply chain diversification reduces risks associated with geopolitical or manufacturing disruptions.
• Emerging trends such as digital quality assurance and sustainable manufacturing are influencing supplier selection criteria.

FAQs

1. Are there supply restrictions for azithromycin due to patent issues?
Most azithromycin patents have expired globally, enabling generic manufacturing, though certain formulations or brand-specific patents may still restrict competition in specific regions.

2. Which regions are the largest producers of azithromycin?
India, China, and Israel are the leading regions for API production, while Europe and North America primarily manufacture finished formulations.

3. How does quality certification affect supplier selection?
Suppliers compliant with WHO GMP, FDA, or EMA standards ensure regulatory approval readiness and reduce quality-related risks.

4. Can contract manufacturers supply azithromycin reliably?
Yes, provided they have validated quality systems, sufficient capacity, and proven regulatory compliance. Such partnerships offer flexibility and risk mitigation.

5. What are the procurement considerations during supply disruptions?
Diversifying suppliers, maintaining safety stock, and fostering strong supplier relationships are key strategies to mitigate impact during interruptions.

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Sources:

[1] Pfizer Inc., “Zithromax (azithromycin) Drug Data,” Pfizer, 2022.
[2] Teva Pharmaceutical Industries Ltd., “Product Portfolio & Manufacturing Capabilities,” Teva, 2023.
[3] Sandoz, “Generics & Biosimilars,” Novartis, 2022.
[4] Lupin Limited, “Global API Manufacturing,” Lupin, 2023.
[5] World Health Organization, “Prequalification of Medicines Program,” WHO, 2022.