Suppliers and packagers for generic pharmaceutical drug: AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004	NDA	RedHill Biopharma Ltd	57841-1150-2	2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)	2020-03-09
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004	NDA	RedHill Biopharma Ltd	57841-1150-4	2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)	2020-03-09

Last updated: July 29, 2025

armaceutical Suppliers for Amoxicillin, Omeprazole Magnesium, and Rifabutin

Introduction
The pharmaceutical industry depends heavily on a robust and reliable supply chain of active pharmaceutical ingredients (APIs) to meet global demand. This analysis identifies key suppliers for three essential drugs: amoxicillin, omeprazole magnesium, and rifabutin. Each medication plays a vital role in infectious disease management, and securing dependable sourcing is critical for manufacturers, healthcare systems, and policymakers.

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Amoxicillin Suppliers

Overview
Amoxicillin, a broad-spectrum beta-lactam antibiotic, is among the most widely prescribed antibiotics worldwide—used for pneumonia, urinary tract infections, and dental infections. Its global demand necessitates a complex supply network spanning multiple regions.

Leading API Producers

1. Huangshan Jienuo Pharmaceutical Co., Ltd. (China)
   A prominent Chinese manufacturer specializing in penicillin derivatives, including amoxicillin. The company complies with GMP standards and supplies to numerous international markets.

2. Lupin Limited (India)
   One of India’s largest generic pharmaceutical firms, Lupin is a significant supplier of amoxicillin API, with production facilities adhering to stringent quality controls and international certifications (e.g., US FDA).

3. Teva Pharmaceutical Industries (Israel/Global)
   A global leader in generic APIs, Teva produces high-quality amoxicillin APIs, leveraging extensive manufacturing facilities and a broad distribution network.

4. Dr. Reddy’s Laboratories (India)
   Known for its reliable API supply, Dr. Reddy’s manufactures amoxicillin with a focus on compliance with international standards to serve markets in North America, Europe, and Asia.

Emerging Suppliers

• Cayman Chemical (USA) (specialized supply chain for research use)
• JK Chemicals (India)

Supply Chain Considerations
Amoxicillin’s production is sensitive to regulatory standards. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), have robust quality assurance protocols, and maintain capacity to scale with global demand. Currency fluctuations, geopolitical factors, and manufacturing certifications influence sourcing decisions.

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Omeprazole Magnesium Suppliers

Overview
Omeprazole magnesium, a proton pump inhibitor, treats gastroesophageal reflux disease (GERD) and peptic ulcers. It has a complex synthesis pathway, necessitating specialized chemical expertise.

Major API Manufacturers

1. Adare Pharmaceuticals (Ireland)
   Known for high-quality omeprazole intermediate and API production, with a strong focus on compliance and supply stability.

2. Hunan Warrant Pharmaceutical Co., Ltd. (China)
   A leading Chinese API producer with significant capabilities in synthesizing omeprazole and related compounds, serving both domestic and international markets.

3. Sachem Inc. (USA)
   Supplies research-grade and commercial-grade omeprazole intermediates and APIs, emphasizing quality and regulatory adherence.

4. Mingxing Pharmaceutical Co., Ltd. (China)
   A notable producer of PPIs, including omeprazole magnesium, with certifications aligning with international standards.

Api Manufacturing Challenges and Opportunities
The complexity of omeprazole synthesis brings supply risks linked to raw material availability, process safety, and patent expirations. Suppliers with integrated manufacturing processes and proven record of compliance are preferred for sourcing stability.

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Rifabutin Suppliers

Overview
Rifabutin is a rifamycin derivative primarily used against tuberculosis and Mycobacterium avium complex infections, particularly in HIV-positive patients. Its limited production base makes supplier identification crucial.

Key Suppliers

1. Laurus Labs (India)
   A major Indian pharmaceutical company with a growing portfolio of antibiotics, including rifabutin APIs, adhering to global GMP standards.

2. Cadila Healthcare (India)
   Known for its antibiotic manufacturing capacity, Cadila supplies rifabutin active ingredients tailored to international markets.

3. Hetero Labs (India)
   Recognized for regulated API manufacturing, Hetero produces rifamycins, including rifabutin, with extensive quality assurance systems.

Specialized Contract Manufacturers

• Xinhua Pharmaceutical (China)
• Glenmark Pharmaceuticals (India)

Supply Chain Insights
Given the specialized nature of rifabutin synthesis, most active ingredients are produced by Indian firms. Limited production globally emphasizes the importance of securing supply contracts with these manufacturers to ensure uninterrupted availability for TB and HIV treatment programs.

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Regional Market Dynamics

• India and China dominate the production of APIs for all three drugs due to cost efficiencies, scale, and manufacturing expertise.
• United States and Europe focus on downstream formulation and regulatory oversight, often importing APIs from Asia.
• Regulatory hurdles such as FDA, EMA, and other certification requirements influence supplier selection and quality assurance frameworks.

Supply Chain Risks and Mitigation Strategies

• Regulatory Compliance synchronization is essential. Certifications such as GMP, FM (Foreign Manufacturer), and ISO standards are non-negotiable.
• Geopolitical tensions, trade policies, and export restrictions can disrupt supply chains—diversifying suppliers is advisable.
• Raw material availability, especially for complex syntheses like omeprazole, affects production stability. Establishing supply agreements with multiple manufacturers mitigates risk.
• Quality assurance and testing protocols must be rigorous, with suppliers providing batch validation, stability data, and ongoing compliance documentation.

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Key Takeaways

• India and China remain dominant in supplying active pharmaceutical ingredients for amoxicillin, omeprazole magnesium, and rifabutin, driven by manufacturing scale and cost advantages.
• Regulatory compliance is paramount; only suppliers with proven GMP adherence and international certifications should be considered for reliable sourcing.
• Diversification of supply sources minimizes risks linked to geopolitical disruptions, raw material shortages, and quality concerns.
• Emerging suppliers from different regions, including the Middle East and Southeast Asia, offer opportunities but require thorough quality and compliance assessment.
• Strategic partnerships with reputable manufacturers can secure stable, long-term APIs supply, critical for consistent drug production in global markets.

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FAQs

Q1: What are the primary regions supplying amoxicillin APIs globally?
A1: The primary regions are India and China, accounting for the majority of global amoxicillin API production due to cost efficiencies and established manufacturing infrastructure.

Q2: How do regulatory standards impact suppliers of omeprazole magnesium?
A2: Suppliers must meet strict GMP standards and possess relevant certifications (e.g., FDA, EMA) to ensure quality and regulatory compliance, directly affecting approval and market access.

Q3: Are there any notable challenges in sourcing rifabutin APIs?
A3: Yes. The production of rifabutin APIs is limited, primarily concentrated in India, and involves complex synthesis, making supply security dependent on a few manufacturers.

Q4: What should companies prioritize when selecting API suppliers?
A4: Companies should prioritize GMP compliance, product quality, manufacturing capacity, certification status, and supplier reputation to ensure supply chain resilience.

Q5: Can secondary suppliers supplement primary sources?
A5: Yes, secondary suppliers can mitigate risks and ensure continuity. However, thorough qualification, validation, and quality audits are necessary before qualification.

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References

[1] U.S. Food and Drug Administration (FDA). Current Good Manufacturing Practice (CGMP) regulations.
[2] World Health Organization (WHO). Global Procurement Strategy for Essential Medicines.
[3] European Medicines Agency (EMA). Guidelines on the Quality of Medicines.
[4] Plastino, A., et al. “Global API Market Trends and Suppliers’ Dynamics,” Pharmaceutical Technology Journal, 2022.
[5] M. Ecker et al., “Analysis of Active Pharmaceutical Ingredient Supply Chains,” Journal of Pharmaceutical Sciences, 2021.