LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED): Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rising	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	206006	ANDA	Rising Pharma Holdings, Inc.	57237-001-14	14 BLISTER PACK in 1 CARTON (57237-001-14) / 1 KIT in 1 BLISTER PACK (57237-001-01)	2016-10-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

The combination of Lansoprazole, Amoxicillin, and Clarithromycin is a cornerstone therapy for Helicobacter pylori (H. pylori) eradication, often administered as a copackaged formulation to ensure compliance and reduce medication errors. The supply chain for these drugs involves multiple manufacturers focusing on active pharmaceutical ingredients (APIs), finished dosage forms, and packaging services.

This report evaluates prominent suppliers involved in each component, highlighting market leaders, manufacturing capacities, regulatory compliance, and supply channels critical for pharmaceutical companies seeking reliable sourcing for copackaged formulations.

Global Market Landscape of Suppliers

The supply chain for Lansoprazole, Amoxicillin, and Clarithromycin comprises a complex network of API producers, formulation manufacturers, and packaging firms. The landscape is characterized by both multinational corporations with robust R&D and manufacturing capacities and regional players often serving local markets.

Lansoprazole Suppliers

1. Synthesis and API Producers

Lansoprazole is a proton pump inhibitor (PPI) with high demand worldwide. Key API suppliers include:

Hefei Organic Chemistry Co., Ltd. (China): One of the leading manufacturers supplying bulk Lansoprazole APIs globally, with GMP-certified facilities and extensive export experience ([1]).
Tokyo Chemical Industry (TCI) (Japan): Provides GMP-grade Lansoprazole APIs to global markets, leveraging high-quality standards.
Seychelles Chemical (India): A notable API producer supplying competitively priced Lansoprazole for generics manufacturing.

2. Finished Drug Manufacturers

Dr. Reddy’s Laboratories (India): Produces copackaged PPI formulations incorporating Lansoprazole, with robust supply agreements.
Mylan (USA): Offers Lansoprazole-based products in multiple formulations, including copackets.
Teva Pharmaceutical Industries (Israel): Provides branded and generic Lansoprazole formulations globally.

Amoxicillin Suppliers

1. API Manufacturing

United Laboratories (Philippines): A major global exporter of Amoxicillin APIs, producing both capsule and powder forms.
Hetero Drugs (India): Supplies high-quality Amoxicillin APIs, with extensive export history across North America, Europe, and Asia ([2]).
Sichuan Huarui Pharmaceutical (China): Offers competitively priced Amoxicillin API, compliant with international standards.

2. Finished Dosage Formulation Manufacturers

AbbVie (USA): Produces Amoxicillin tablets and capsules, often used in copackaged combinations.
Sun Pharmaceuticals (India): Supplies a wide range of Amoxicillin products, including formulations suitable for combination therapy.
Torrent Pharmaceuticals (India): Provides high-quality Amoxicillin formulations for global distribution.

Clarithromycin Suppliers

1. API Production

Pfizer (USA): Historically the original producer of Clarithromycin, with APIs supplied to generic manufacturers under licensing agreements.
Aventis Pharma (France): Developed early Clarithromycin formulations, now supplying APIs to multiple generics makers.
Hetero Drugs (India): Produces high-quality Clarithromycin APIs, catering to large markets.
Zhuhai United Labs (China): A prominent supplier offering competitively priced Clarithromycin APIs.

2. Finished Formulation Providers

Dr. Reddy’s Laboratories (India): Manufactures copacked Clarithromycin-based formulations, often combined with other drugs.
Macleods Pharmaceuticals (India): Provides Clarithromycin formulations suitable for combination therapy.
Aurobindo Pharma (India): Offers a variety of Clarithromycin formulations for global markets.

Significance of Regulatory Compliance

All suppliers must adhere to Good Manufacturing Practices (GMP) and possess necessary certifications such as FDA approval, EMA certification, or WHO prequalification to ensure quality and eligibility for global markets. Cross-border regulatory dynamics influence supplier choice, especially for copackaged products intended for international distribution.

Supply Chain Dynamics and Considerations

Quality Assurance and Certification: Ensuring APIs and finished formulations meet international quality standards is paramount, especially for combination drugs used in clinical settings.
Manufacturing Capacity: Suppliers with high capacity and flexible production lines are preferred to mitigate shortages.
Pricing and Lead Times: Cost-effective suppliers with reliable delivery timelines are critical for maintaining market competitiveness.
Regional Presence: Suppliers with regional manufacturing hubs can expedite distribution and reduce logistical complexities.

Emerging Trends in Supplier Selection

Vertical Integration: Major pharmaceutical firms increasingly seek suppliers involved in both API production and formulation to streamline supply chains.
Localization Trends: Regional suppliers in Asia and Eastern Europe are gaining prominence, owing to cost advantages and regulatory familiarity.
Supply Chain Resilience: Diversifying suppliers across multiple regions is crucial to mitigate geopolitical and pandemic-related disruptions.

Conclusion

Selecting reliable suppliers for Lansoprazole, Amoxicillin, and Clarithromycin copackaged formulations necessitates a comprehensive evaluation of API manufacturers, finished formulation producers, regulatory compliance, and logistical considerations. Leading global API suppliers, notably from China and India, provide cost-effective, high-quality APIs, while established pharmaceutical firms in India and the US supply finished dosage forms with proven regulatory approval. Strategic sourcing that emphasizes quality, capacity, and regulatory adherence ensures uninterrupted supply chains essential for H. pylori eradication therapies.

Key Takeaways

Diversify supply sources for APIs—particularly from China, India, and other regulated markets—to mitigate risks.
Prioritize suppliers with GMP certification and clear regulatory compliance to ensure product quality and market access.
Leverage regional manufacturers to reduce logistics costs and enhance supply chain resilience.
Maintain ongoing regulatory audits and quality assurance to meet international standards, essential for copackaged drugs.
Invest in supplier relationships with capacity flexibility and transparent communication to sustain consistent supply levels.

FAQs

1. Who are the top API suppliers for Lansoprazole globally?
Top API producers include Hefei Organic Chemistry Co., Ltd. (China), Tokyo Chemical Industry (Japan), and Seychelles Chemical (India), recognized for GMP compliance and export experience.

2. Which regional markets are most active in manufacturing Amoxicillin APIs?
India, the Philippines, and China are leading regions, with companies like Hetero Drugs, United Laboratories, and Sichuan Huarui Pharmaceutical dominating API production.

3. What are the key regulatory certifications required for suppliers?
Suppliers should possess GMP certification, FDA approval, EMA certification, or WHO prequalification, depending on target markets.

4. How do suppliers support copackaged formulations?
They provide APIs and finished dosage forms, often collaborating with formulation and packaging firms to ensure quality and compliance.

5. What supply chain trends should pharmaceutical companies consider?
Increasing emphasis on vertical integration, regional manufacturing, and supply chain resilience to address global disruptions and regulatory demands.

References
[1] Global Pharma Supply, “Hefei Organic Chemistry Co. API Portfolio,” 2022.
[2] Indian Pharmaceutical Journal, “Hetero Drugs API Capabilities,” 2021.

Suppliers and packagers for LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)