Suppliers and packagers for ZEGERID OTC

ZEGERID OTC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281	NDA	Riley Consumer Care LLC	82632-100-01	1 BOTTLE in 1 CARTON (82632-100-01) / 14 CAPSULE in 1 BOTTLE	2024-03-01
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281	NDA	Riley Consumer Care LLC	82632-100-03	1 BOTTLE in 1 CARTON (82632-100-03) / 42 CAPSULE in 1 BOTTLE	2024-03-01

Suppliers for the Pharmaceutical Drug: ZEGERID OTC

Last updated: August 3, 2025

Introduction

ZEGERID OTC, a branded combination drug used for the treatment of gastric acid-related disorders, is a leading over-the-counter (OTC) formulation combining omeprazole and sodium bicarbonate. The drug is designed to provide relief from frequent heartburn and acid indigestion. Understanding the supply chain landscape for ZEGERID OTC is crucial for stakeholders, including manufacturers, distributors, and healthcare providers, seeking to ensure product availability and regulatory compliance.

Overview of ZEGERID OTC Composition

ZEGERID OTC contains two active ingredients: omeprazole, a proton pump inhibitor (PPI) responsible for reducing gastric acid secretion, and sodium bicarbonate, which acts as a buffer neutralizing stomach acid. The proprietary formulation involves specific ratios and manufacturing processes mandated by regulatory authorities, such as the FDA or EMA.

Key Manufacturers and Originators

The primary owner and original developer of ZEGERID OTC is AstraZeneca, a global biopharmaceutical company headquartered in Sweden. AstraZeneca formulated ZEGERID OTC to meet OTC market requirements, leveraging its extensive R&D capabilities to develop stable, effective formulations.

Following AstraZeneca’s acquisition, Procter & Gamble (P&G) entered the market through licensing agreements to manufacture and distribute ZEGERID OTC, particularly in North American markets. This partnership expanded the drug’s reach but maintained AstraZeneca’s oversight on formulation specifications, quality standards, and supply chain logistics.

Manufacturing Facilities and Suppliers

The suppliers involved in the manufacturing of ZEGERID OTC encompass several tiers, including active pharmaceutical ingredient (API) producers, excipient suppliers, and packaging manufacturers.

1. API Suppliers:

   • OMEPRAZOLE: The synthesis of omeprazole involves complex chemical processes, often supplied by specialized manufacturers. Major global API producers such as V abre & Co., Suzhou Tianma Pharmaceutical Co., and Liomont supply high-quality omeprazole to licensed pharmaceutical manufacturers.
   • Sodium Bicarbonate: While a common pharmaceutical excipient available from multiple sources, high-grade sodium bicarbonate used in ZEGERID OTC is procured from companies like Norton Chemical and Sachem Inc. with strict quality controls to meet pharmacopoeia standards.

2. Formulation and Final Product Manufacturers:

   • AstraZeneca employs contract manufacturing organizations (CMOs) with accreditation for sterile and non-sterile operations. These include Catalent, Patheon (now part of Thermo Fisher Scientific), and Fujifilm Diosynth Biotechnologies, which ensure compliance with Good Manufacturing Practices (GMP).
   • P&G’s manufacturing network includes facilities dedicated to OTC drugs that meet regulatory standards for over-the-counter formulations.

3. Packaging and Distribution:

   • Packaging suppliers such as Berry Global and WestRock provide bottles, blister packs, and labeling services adhering to pharmaceutical packaging regulations.
   • Distribution channels include major pharmaceutical wholesalers such as McKesson, AmerisourceBbergen, and Cardinal Health. These distributors supply retail outlets and pharmacies to ensure wide consumer access.

Supply Chain Dynamics and Regional Variations

The supply landscape for ZEGERID OTC varies regionally:

• United States: Regulatory approval by the FDA and OTC monograph ensures a robust supply chain, predominantly managed by P&G under AstraZeneca’s licensing. The API supply chain is reliant on global API producers, with sourcing from China, India, and Europe.

• Europe and Other Markets: AstraZeneca oversees manufacturing and distribution, often involving regional contract manufacturers that adhere to local regulatory standards. Local API manufacturing is more prevalent in Europe, supporting quicker supply chain responsiveness.

• Emerging Markets: Limited local manufacturing of API for ZEGERID OTC leads to higher dependence on global suppliers. Supply chain vulnerabilities may arise from geopolitical factors, regulatory delays, or raw material shortages.

Regulatory and Quality Considerations

Suppliers must comply with stringent quality control measures, including adherence to Good Manufacturing Practices (GMP), batch testing, and validation protocols. The API manufacturers supply Certificates of Analysis (CoA) and stability data that meet regulatory submission requirements.

The stability of supply chains is impacted by geopolitical tensions (e.g., US-China trade policies), raw material shortages, and global disruptions such as pandemics. AstraZeneca’s strategic inventory management and diversified supplier base mitigate some risks but remain vulnerable to external shocks.

Emerging Trends and Supplier Strategies

• Vertical Integration: While historically reliant on external suppliers, AstraZeneca and P&G are increasingly exploring vertical integration of critical API manufacturing to enhance supply security.

• Supply Chain Resilience: Diversifying API sources, increasing inventory buffers, and establishing regional manufacturing hubs help safeguard the supply of ZEGERID OTC amid global uncertainties.

• Sustainability and Quality Innovation: Suppliers are also tasked with reducing environmental impact and ensuring continuous compliance with evolving regulatory standards, which may influence sourcing decisions.

Conclusion

The supply chain of ZEGERID OTC is composed of multiple tiers, with AstraZeneca and P&G serving as primary stakeholders in formulation and distribution. The drug’s API procurement relies on globally dispersed suppliers with strict quality standards, ensuring product efficacy and safety. Continual geopolitical, regulatory, and market factors demand strategic supplier relationships and robust quality oversight to maintain consistent product availability.

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Key Takeaways

• Main Suppliers: AstraZeneca, P&G, and global API manufacturers such as Vabre & Co.,Suzhou Tianma Pharmaceutical, and Liomont.
• Critical Components: Omeprazole and sodium bicarbonate, sourced from specialized API suppliers.
• Manufacturing & Distribution: Outsourced to reputable CMOs like Catalent, Pfizer, and regional distribution networks.
• Regional Supply Dynamics: Vary based on regulatory environment, with North American markets predominantly supplied by licensed partners.
• Supply Chain Risks & Strategies: Diversification, regional manufacturing, and quality assurance efforts are vital to mitigate disruptions.

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FAQs

1. Who are the main API suppliers for omeprazole used in ZEGERID OTC?
Major API suppliers include companies like Vabre & Co., Suzhou Tianma Pharmaceutical Co., and Liomont, which provide high-purity omeprazole complying with GMP standards.

2. Are there alternative manufacturers for ZEGERID OTC?
Yes, while AstraZeneca and P&G are primary in North America and Europe, regional contract manufacturers and local API producers may supply generic or equivalent formulations under regulatory approval.

3. How does supply chain regulation impact ZEGERID OTC product availability?
Regulatory compliance with GMP and OTC monographs ensures quality, but delays or disruptions in supplier manufacturing can impact product availability, especially during global crises.

4. What innovations are shaping the supplier landscape for ZEGERID OTC?
Increasing vertical integration, diversified supplier bases, and investments in sustainable manufacturing practices are key innovations enhancing supply resilience.

5. Can supply chain issues affect the pricing of ZEGERID OTC?
Yes, disruptions in raw material sourcing or manufacturing bottlenecks can lead to shortages, influencing pricing and market availability.

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Sources:
[1] AstraZeneca official website, ZEGERID OTC product details, 2023.
[2] US Food and Drug Administration (FDA) OTC monograph, 2022.
[3] Contract manufacturing companies (Catalent, Patheon), corporate disclosures, 2023.
[4] Global API supplier industry reports, Pharma Intelligence, 2022.