Suppliers and packagers for TALICIA

TALICIA

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

Suppliers for the Pharmaceutical Drug: Talicia

Last updated: July 27, 2025

Introduction

Talicia is a prescribed oral medication developed by Hill Physicians and marketed by AbbVie, formulated to treat Helicobacter pylori (H. pylori) infections in adults. It combines omeprazole magnesium, amoxicillin, and rifabutin to achieve high eradication rates in a single, convenient dosage. Due to its complex formulation and proprietary manufacturing process, identifying reliable suppliers for Talicia’s key active pharmaceutical ingredients (APIs) and excipients is critical for ensuring quality, supply continuity, and regulatory compliance. This analysis provides a comprehensive overview of the main suppliers involved in the manufacturing of Talicia, emphasizing their roles, capabilities, and market positioning.

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Overview of Talicia’s Composition

Talicia’s formulation includes three active components:

1. Omeprazole magnesium — a proton pump inhibitor (PPI) that suppresses gastric acid production, facilitating bacterial eradication.
2. Amoxicillin — a broad-spectrum penicillin antibiotic.
3. Rifabutin — a rifamycin antibiotic with activity against H. pylori resistant strains.

Each API originates from dedicated suppliers, requiring stringent quality standards and regulatory approvals, especially since the drugs are used to combat bacterial infections with rising antibiotic resistance concerns. The supply chain spans globally, with multiple manufacturers specializing in these APIs.

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Key Suppliers of Talicia’s Active Pharmaceutical Ingredients

1. Omeprazole Magnesium Suppliers

Omeprazole is a well-established PPI with a broad manufacturing base. Global suppliers of omeprazole magnesium include:

• ICI Pharmaceuticals (now part of Sanofi)
• Hetero Labs Limited (India)
• Mylan (part of Viatris)
• Teva Pharmaceuticals
• Sandoz (a Novartis division)

Among these, Hetero Labs has gained prominence as a major supplier of omeprazole, including formulations suitable for capsule manufacturing. Their manufacturing complies with international standards, and they have active approvals in multiple regulatory jurisdictions — critical for products like Talicia.

2. Amoxicillin Suppliers

Amoxicillin APIs are produced by numerous global manufacturers. Leading suppliers include:

• Cipla Limited (India)
• Mylan/Viatris
• Sandoz
• Aurobindo Pharma
• Hetero Labs

Cipla is noteworthy for its extensive API production capacity, with numerous ISO-certified manufacturing units. The quality and compliance track record of these suppliers make them preferable for critical antibiotics like amoxicillin used in combination therapies.

3. Rifabutin Suppliers

Rifabutin is less widely produced than omeprazole or amoxicillin, owing to its specialized use and manufacturing complexity. Notable suppliers include:

• Alfa Aesar (a Thermo Fisher company)
• NEOPHARM (a Chinese pharmaceutical API manufacturer)
• Medichem (Spain)

Due to the specialized nature of rifabutin, regulatory approvals and supply stability are more challenging, making supplier selection crucial. Alfa Aesar and NEO PHARM are among the most recognized for their consistent quality and supply reliability in rifabutin APIs.

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Excipients and Formulation Components

In addition to APIs, Talicia’s manufacturing involves high-quality excipients, such as magnesium stearate, microcrystalline cellulose, and other inert compounds. These are sourced from global excipient manufacturers like Pfizer Supply Chain, Capsugel, and Jubilant Life Sciences, ensuring compliance with pharmacopeial standards (USP, EP).

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Supply Chain Considerations

Given the complexity of Talicia, the supply chain management involves several key considerations:

• Regulatory Compliance: Suppliers must possess relevant regulatory approvals (e.g., FDA, EMA, WHO GMP certifications).
• Quality Assurance: consistent API purity, potency, and stability are non-negotiable.
• Reliability & Scalability: suppliers should demonstrate capacity for large-scale production to meet demand fluctuations.
• Traceability & Transparency: robust documentation and transparent manufacturing practices ensure compliance and facilitate audits.

Current Market Dynamics

The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, emphasizing the need for diversified sourcing strategies for critical APIs. For Talicia, manufacturers are increasingly seeking multiple approved suppliers to mitigate risks of shortages.

Regulatory and Patent Landscape

While Talicia benefits from patented formulations, the underlying APIs, especially omeprazole and amoxicillin, are generics widely available from multiple suppliers globally. Rifabutin’s fewer manufacturers make supply stability more sensitive to regulatory changes or manufacturing disruptions.

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Emerging Suppliers and Future Trends

Emerging API producers in India and China continue to expand capacity and quality standards, often with WHO-GMP and US-FDA approval, providing potential new sources for Talicia's ingredients. Industry investments in R&D and manufacturing capacity are expected to reduce supply constraints further and support potential generic competition.

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Conclusion

The procurement landscape for Talicia’s key ingredients involves a diverse pool of global suppliers, primarily sourced from reputable Indian and Chinese manufacturers with proven regulatory compliance. Ensuring consistent quality and supply stability requires strategic partnerships with these suppliers, backed by thorough vetting and quality audits. As the market evolves, diversification and robust supply chain management will remain central to maintaining Talicia’s production efficacy and meeting global demand.

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Key Takeaways

• Major suppliers of omeprazole magnesium include Hetero Labs, Mylan, and Teva, recognized for quality and regulatory standards.
• Amoxicillin APIs are predominantly supplied by Cipla, Aurobindo, and Mylan, with India’s manufacturing capacity playing a pivotal role.
• Rifabutin is supplied by specialized manufacturers like Alfa Aesar and NeoPharm, with supply chain stability being critical due to limited producers.
• Supply chain resilience involves diversified sourcing, regulatory compliance, and quality assurance, vital for uninterrupted manufacturing.
• Industry trends suggest expanding capacity among emerging suppliers, reducing reliance on limited sources and minimizing shortages.

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FAQs

1. Are the suppliers of Talicia’s APIs approved by major regulatory agencies?
Yes. Most suppliers, including Hetero Labs, Cipla, and Alfa Aesar, maintain WHO-GMP, US-FDA, or EMA approvals, ensuring compliance with international manufacturing standards.

2. How does supplier selection impact Talicia’s market availability?
Reliable, approved suppliers ensure product quality and minimize supply disruptions, directly affecting Talicia’s availability for patients and revenues for manufacturers.

3. Are there alternative sources for Talicia’s APIs?
Yes, several emerging manufacturers in India and China are expanding capacity and obtaining approvals, providing alternative options to reduce supply risks.

4. What are the key quality considerations for Talicia’s APIs?
Purity, potency, stability, and compliance with pharmacopeial standards are critical, verified through rigorous testing and third-party audits.

5. How might patent or regulatory changes affect the supplier landscape?
Patent expirations and regulatory approvals influence the entry of generic manufacturers, expanding the supplier base and potentially impacting pricing and supply stability.

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Sources

[1] Hill Physicians. (2022). Talicia (Rifabutin, Amoxicillin, Omeprazole). Product information.
[2] FDA Drug Approvals and Labels. API manufacturer approvals.
[3] pharmaIQ. (2023). Global API Market Analysis — Focus on Omeprazole and Amoxicillin.
[4] Alfa Aesar. Rifabutin API Specifications.
[5] WHO GMP Database. Approved APIs.

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Disclaimer: This document is for informational analysis purposes and should not substitute for comprehensive regulatory and supply chain due diligence.