Suppliers and packagers for generic pharmaceutical drug: omeprazole

omeprazole

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	076048	ANDA	Apotex Corp	60505-0065-0	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-0)	2003-11-11
Apotex	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	076048	ANDA	Apotex Corp	60505-0065-1	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-1)	2003-11-11
Apotex	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	076048	ANDA	Apotex Corp	60505-0065-2	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-2)	2003-11-11
Apotex	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	076048	ANDA	Apotex Corp	60505-0145-0	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-0)	2003-11-11
Apotex	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	076048	ANDA	Apotex Corp	60505-0145-2	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-2)	2003-11-11

Suppliers for the Pharmaceutical Drug: Omeprazole

Last updated: July 29, 2025

Introduction

Omeprazole, a widely prescribed proton pump inhibitor (PPI), plays a crucial role in managing conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. As a highly sought-after medication, its supply chain is complex, involving numerous suppliers across the pharmaceutical and active pharmaceutical ingredient (API) markets. Ensuring a reliable supply of omeprazole necessitates a comprehensive understanding of its principal suppliers, manufacturing hubs, regulatory considerations, and market dynamics. This report provides an in-depth analysis of key suppliers supplying omeprazole globally, focusing on manufacturers, API producers, and distribution channels vital for pharmaceutical companies, healthcare providers, and stakeholders involved in drug procurement.

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Manufacturers of Omeprazole

Branded Pharmaceutical Companies

The original formulation of omeprazole was developed by AstraZeneca, which introduced it to the market as Prilosec in 1989. AstraZeneca retains patent rights and is a key supplier of the branded version, although many generic manufacturers have entered the market post-expiration of patent protections.

AstraZeneca: As the pioneer, AstraZeneca remains a significant supplier of omeprazole in markets where brand loyalty prevails or where patent protections are still in force. However, in most countries, AstraZeneca's supply shares have been largely replaced by generic counterparts.

Generic Pharmaceutical Manufacturers

The expiration of AstraZeneca’s patent in the early 2000s unleashed a surge of generic manufacturers globally, significantly expanding supply sources for omeprazole. Key players include:

• Teva Pharmaceutical Industries: A dominant global generic pharmaceutical producer, Teva supplies omeprazole in various formulations and strengths, leveraging its extensive manufacturing capacity (~80+ facilities worldwide) and broad distribution network.

• Sandoz (Novartis): Sandoz, a Sigma-Aldrich division, offers a comprehensive portfolio of generic omeprazole in oral capsule and tablet forms, serving markets across North America and Europe with high compliance standards.

• Mylan (now part of Viatris): Mylan became a prominent supplier of generic omeprazole, providing affordable options extensively across developing and developed markets.

• Dr. Reddy’s Laboratories: An Indian pharmaceutical giant, Dr. Reddy’s produces and supplies omeprazole generics to numerous countries, with a focus on Asian, African, and Latin American markets.

• Aurobindo Pharma: India-based Aurobindo manufactures omeprazole APIs and finished products, emphasizing high-quality production compliant with international regulatory standards.

• Hikma Pharmaceuticals: Operating across multiple regions, Hikma supplies omeprazole in various dosage forms, emphasizing reliable quality and supply chain efficiency.

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Active Pharmaceutical Ingredient (API) Suppliers

The stability and scalability of omeprazole supply heavily depend on API manufacturing. Omeprazole’s complex synthesis involves multiple chemical intermediates, necessitating advanced manufacturing facilities with stringent quality controls.

Leading API suppliers include:

• Suzhou Hande Biologicals (China): A major API manufacturer supplying bulk omeprazole API for global markets, known for cost-effective production and adherence to international Good Manufacturing Practices (GMP).

• Cipla Limited (India): Besides producing finished formulations, Cipla supplies high-quality APIs, including omeprazole, from its certified facilities catering to both domestic and export markets.

• Hetero Labs (India): A notable API producer with capabilities in complex APIs like omeprazole, exporting to several generic drug manufacturers worldwide.

• Shandong Jinhui Group (China): Emerging as a significant API provider, Jinhui specializes in proton pump inhibitors, including omeprazole, with expanded global outreach.

Regulatory Considerations: API suppliers must maintain compliance with the US FDA, EMA, and other national authorities’ standards to ensure market access. Many of these Chinese and Indian API producers have achieved certifications such as cGMP, ISO, and FDA approval, ensuring quality consistency essential for global supply.

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Distribution and Supply Chain Dynamics

The global omeprazole supply chain comprises API producers, formulators, wholesalers, and distributors. The main challenges involve regulatory compliance, quality assurance, cost efficiency, and geopolitical stability.

• Regional Suppliers: U.S. and European markets predominantly depend on established API producers with stringent quality standards, primarily European and North American manufacturers. Conversely, Asian suppliers—particularly Indian and Chinese firms—offer cost-effective APIs meeting international standards, fueling the generic market expansion.

• Supply Vulnerabilities: Recent disruptions due to geopolitical tensions, COVID-19 pandemic impacts on manufacturing, and supply chain bottlenecks have underscored the importance of diversification among suppliers.

• Regulatory Approvals: Suppliers with FDA, EMA, or Health Canada approval tend to dominate high-regulation markets, fostering confidence in supply chain integrity.

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Emerging Trends and Market Outlook

• Vertical Integration: Large pharmaceutical firms increasingly integrate API manufacturing with finished drug production to secure supply chains, reduce costs, and expand control.

• Bioequivalent and Formulation Innovations: Development of novel delivery formulations, such as granules and dispersible tablets, requires new supplier capabilities, opening opportunities for niche API suppliers.

• Regional Expansion: Emerging markets see growth in local API production capabilities, decreasing dependence on imports and aligning with government policies to foster domestic pharmaceutical manufacturing.

• Supply Chain Resilience: The push for diversified sourcing, regional manufacturing hubs, and strategic stockpiles aims to mitigate future supply disruptions.

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Conclusion

The supply landscape for omeprazole exhibits significant diversification with key manufacturers spanning global regions. Major branded suppliers like AstraZeneca have been overtaken in market share by a swelling tide of generic manufacturers, predominantly from India and China. API production remains critical, with several high-capacity producers providing quality raw materials necessary for the continued availability of omeprazole worldwide.

Ensuring a stable supply chain involves careful evaluation of supplier compliance with international standards, strategic diversification, and an understanding of geopolitical factors influencing manufacturing and logistics. As demand persists, both established pharmaceutical companies and emerging players will continue to shape the evolving supply ecosystem for omeprazole.

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Key Takeaways

• Global supplier landscape is dominated by generic manufactures, with Teva, Sandoz, Mylan/Viatris, and Indian API producers leading the market.

• API manufacturing is concentrated in China and India, requiring rigorous quality standards to meet international regulatory needs.

• Supply chain resilience is increasingly critical; diversification strategies and regional manufacturing hubs enhance stability.

• Regulatory compliance influences supplier selection, favoring those with FDA, EMA, and other certifications.

• Market growth driven by demand for affordable alternatives and formulation innovations will sustain competitive dynamics among suppliers.

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FAQs

1. Who are the leading suppliers of omeprazole in the generic market?
Leading generic manufacturers include Teva Pharmaceutical Industries, Sandoz (a Novartis division), Mylan/Viatris, Dr. Reddy’s Laboratories, Aurobindo Pharma, and Hikma Pharmaceuticals.

2. Where is the majority of omeprazole API produced?
Most omeprazole API is produced in China and India, with companies like Suzhou Hande Biologicals, Shandong Jinhui Group, Cipla, and Hetero Labs leading the supply.

3. What regulatory standards must API suppliers meet to export omeprazole?
API suppliers should achieve certifications such as cGMP, ISO, and be approved by regulatory agencies like the FDA or EMA to ensure quality and facilitate international market access.

4. How has the patent expiration affected the omeprazole supply chain?
Patent expiration in the early 2000s led to a surge of generic manufacturers, expanding supply sources, reducing costs, and increasing availability across global markets.

5. What are the future trends impacting omeprazole suppliers?
Emerging trends include vertical integration, formulation innovation, regional manufacturing expansion, and strategies for supply chain resilience against geopolitical and pandemic-related disruptions.

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Sources:

[1] AstraZeneca Official Website. "Prilosec (Omeprazole)." Accessed 2023.
[2] EvaluatePharma. "Global Proton Pump Inhibitors Market Analysis." 2022.
[3] US FDA. "Approved Drug Product Listings." 2023.
[4] IQVIA. "Top Global Pharmaceutical Manufacturers." 2022.
[5] GlobalData. "API Market Insights and Trends." 2023.