Suppliers and packagers for ZEGERID

ZEGERID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849	NDA	Santarus, Inc..	68012-102-30	30 CAPSULE in 1 BOTTLE (68012-102-30)	2006-02-27
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849	NDA	Santarus, Inc..	68012-104-05	5 CAPSULE in 1 BOTTLE (68012-104-05)	2006-02-27
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849	NDA	Santarus, Inc..	68012-104-30	30 CAPSULE in 1 BOTTLE (68012-104-30)	2006-02-27
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-102-30	30 CAPSULE in 1 BOTTLE (68682-102-30)	2006-02-27

Suppliers for the Pharmaceutical Drug: ZEGERID

Last updated: August 2, 2025

Introduction
ZEGERID, a gastroesophageal reflux disease (GERD) medication, is a prescription drug combining omeprazole and sodium bicarbonate. It is marketed under the brand name ZEGERID by AstraZeneca, with formulations including capsules and oral suspension. As a proton pump inhibitor (PPI), ZEGERID's efficacy hinges on a consistent supply chain and strategic supplier relationships. This article delves into the key suppliers involved in the manufacturing and distribution of ZEGERID, the strategic considerations behind sourcing, and implications for stakeholders.

Overview of ZEGERID's Formulation and Manufacturing
ZEGERID's primary active ingredients are omeprazole, a PPI that suppresses gastric acid secretion, and sodium bicarbonate, which neutralizes stomach acid and facilitates omeprazole's stability in the gastrointestinal tract. The manufacturing process involves sourcing high-quality active pharmaceutical ingredients (APIs), excipients, and packaging materials. Effective sourcing ensures drug consistency, safety, and supply chain resilience.

Active Pharmaceutical Ingredient (API) Suppliers

Omeprazole
As the cornerstone API, omeprazole sourcing is critical. Large pharmaceutical companies often rely on specialized APIs providers with proven quality assurance and regulatory compliance. Industry leaders such as Dr. Reddy’s Laboratories, Teva Pharmaceuticals, and Mylan have historically supplied omeprazole globally. However, for branded drugs like ZEGERID, AstraZeneca typically contracts with high-quality, cGMP-compliant manufacturers that meet stringent regulatory standards, including those certified by agencies like the FDA, EMA, or equivalent authorities.

Excipients and Other Raw Materials
Sodium bicarbonate, the buffering agent, is sourced from global chemical suppliers like Solvay, Innophos, and Evonik Industries. These companies supply pharmaceutical-grade bicarbonate, complying with pharmacopeial standards. Other excipients, such as capsules or suspension excipients, are sourced from specialized pharmaceutical excipient suppliers that meet regulatory requirements.

Contract Manufacturing Organizations (CMOs)
While AstraZeneca maintains owned manufacturing facilities, it also partners with CMOs globally to scale production efficiently and mitigate supply risks. CMOs specializing in oral solid dose manufacturing or sterile liquid forms handle specific processes. For ZEGERID, CMOs such as Catalent, Patheon (a part of Thermo Fisher Scientific), and Jiangsu Hengrui Medicine Co. may be involved, particularly for overseas or high-volume manufacturing. These partnerships enable AstraZeneca to optimize capacity, ensure quality, and sustain supply chains amid global disruptions.

Packaging and Distribution Suppliers
Besides active ingredients, packaging materials, including blisters, bottles, labels, and carton boxes, originate from specialized suppliers like Amcor and Constantia Flexibles. Packaging suppliers are selected based on quality standards, regulatory compliance, and ability to meet global distribution demands.

Distribution channels involve logistics providers such as DHL, FedEx, and pharmaceutical-specific carriers that ensure cold chain and temperature-sensitive logistics, particularly for formulations requiring refrigeration or specific environmental controls.

Strategic Sourcing Considerations

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP), International Organization for Standardization (ISO) standards, and pharmacopeial specifications. Regulatory agencies rigorously audit suppliers, influencing AstraZeneca’s selection.

• Supply Chain Resilience: Diversifying suppliers for APIs, excipients, and packaging mitigates risks associated with geopolitical instability, natural disasters, or pandemics. Recent disruptions in the COVID-19 pandemic highlighted the importance of robust, multi-sourced supply chains.

• Quality Assurance: Stringent quality control and testing at every supply chain node prevent contamination, ensure potency, and uphold regulatory approval status.

• Cost and Lead Time: Balancing quality with cost efficiency is crucial. Long-term partnerships with reliable suppliers can improve lead times and supply predictability.

Implications for Stakeholders

Pharmaceutical Companies
Reliance on a diversified supplier base reduces potential shortages, facilitating consistent drug availability. Regulatory compliance and quality assurance are non-negotiable, dictating supplier criteria.

Healthcare Providers and Patients
Secure and uninterrupted supply chains mitigate risks of drug shortages, ensuring patient adherence and treatment efficacy.

Regulators and Policymakers
Monitoring the integrity of supply chains through audits and certifications enhances drug safety and supply security.

Future Trends in ZEGERID Suppliers

• Local Manufacturing Initiatives
  Governments and pharmaceutical firms are encouraging local API manufacturing to reduce dependency on imports, especially in regions like North America and Europe. Such strategies could reshape the supplier landscape for drugs like ZEGERID.

• Advanced Manufacturing Technologies
  Implementation of continuous manufacturing and digital quality controls improve agility and reliability of supply.

• Sustainability and Ethical Sourcing
  Increasing focus on environmentally sustainable practices influences supplier selection, emphasizing eco-friendly raw material sourcing and waste management.

Conclusion
The supply chain for ZEGERID exemplifies the complexity inherent in sourcing high-quality APIs, excipients, and packaging materials while maintaining regulatory compliance and ensuring resilience. AstraZeneca’s strategic partnerships with diversified, compliant suppliers underpin the drug’s market availability and reputation. Stakeholders should monitor evolving supplier landscapes, emerging regional manufacturing initiatives, and technological advancements that could influence future supply dynamics.

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Key Takeaways

• Diverse and compliant API suppliers are critical for maintaining ZEGERID’s consistent quality and supply.
• Major chemical and pharmaceutical companies like Solvay and Evonik supply key excipients such as sodium bicarbonate.
• Contract manufacturing organizations play a vital role in scaling production and mitigating risks.
• Regulatory compliance, quality assurance, and supply chain resilience are central considerations in supplier selection.
• Emerging regional manufacturing initiatives and technological innovations will influence future supply chain dynamics for ZEGERID.

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FAQs

1. Who are the primary suppliers of omeprazole for ZEGERID?
   Major suppliers include validated API manufacturers such as Dr. Reddy's Laboratories, Teva, and regional producers certified for GMP compliance, with AstraZeneca typically sourcing from high-quality, globally certified providers.

2. How does AstraZeneca ensure the quality of its ZEGERID supply chain?
   Through regulatory audits, strict supplier qualification processes, ongoing quality control testing, and compliance with international standards such as GMP and ISO.

3. Are there regional differences in ZEGERID suppliers?
   Yes, regional manufacturing and sourcing strategies are influenced by local regulations, availability of raw materials, and geopolitical considerations, leading to regional supplier diversification.

4. What role do Contract Manufacturing Organizations play in ZEGERID production?
   CMOs assist with manufacturing scale-up, capacity flexibility, and supply continuity, often operating under strict quality controls and regulatory oversight.

5. What trends could impact ZEGERID's future supplier landscape?
   Emerging regional manufacturing initiatives, technological advancements like continuous manufacturing, and increased focus on sustainability are reshaping supplier strategies globally.

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Sources
[1] AstraZeneca Corporate Website. "ZEGERID Overview."
[2] FDA Pharmaceutical Quality System Guidelines.
[3] Solvay Official Website. "Pharmaceutical-grade Sodium Bicarbonate."
[4] Contract Manufacturing Organization Profiles. Pharmacotech.com.