Suppliers and packagers for generic pharmaceutical drug: OMEPRAZOLE MAGNESIUM

OMEPRAZOLE MAGNESIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	213201	ANDA	Aurohealth LLC	58602-837-05	1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2023-04-28
Dexcel	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096	ANDA	Walgreen Company	0363-6089-01	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-6089-01)	2024-04-09
Dexcel	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096	ANDA	Walgreen Company	0363-6089-03	3 BOTTLE in 1 CARTON (0363-6089-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2024-04-09
Dexcel	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096	ANDA	Safeway	21130-528-01	1 BOTTLE in 1 CARTON (21130-528-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2024-06-03
Dexcel	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096	ANDA	Safeway	21130-528-03	3 BOTTLE in 1 CARTON (21130-528-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2024-06-03
Dexcel	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096	ANDA	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-271-03	3 BOTTLE in 1 CARTON (51316-271-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-271-01)	2025-04-01
Dexcel	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	216096	ANDA	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-843-03	3 BOTTLE in 1 CARTON (51316-843-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-843-01)	2026-02-06

Omeprazole Magnesium Suppliers: Global Landscape and Key Players

Last updated: February 19, 2026

This analysis identifies and profiles key global suppliers of omeprazole magnesium, a proton pump inhibitor used to treat conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. The report details production capacities, regulatory compliance, and market presence to inform strategic sourcing and investment decisions.

Who Are the Primary Manufacturers of Omeprazole Magnesium?

The global manufacturing base for omeprazole magnesium is concentrated across a limited number of countries, with China and India leading in production volume. These regions benefit from established chemical synthesis infrastructure and cost advantages.

• Active Pharmaceutical Ingredient (API) Manufacturers: These companies specialize in the synthesis of the omeprazole magnesium API.
• Finished Dosage Form (FDF) Manufacturers: These companies formulate the API into final drug products (e.g., capsules, tablets) for commercial sale.

Several companies operate as both API and FDF manufacturers.

Leading API Suppliers

The following companies are identified as significant suppliers of omeprazole magnesium API:

• Aarti Drugs Ltd. (India): A prominent Indian pharmaceutical company with a strong presence in API manufacturing, including omeprazole. Their facilities are compliant with major regulatory standards.
• Divi's Laboratories Ltd. (India): Known for its large-scale API production, Divi's is a significant player in the omeprazole market. They emphasize backward integration and robust quality control.
• Lupin Ltd. (India): A global pharmaceutical company that manufactures a range of APIs, including omeprazole, for both domestic and international markets.
• Sun Pharmaceutical Industries Ltd. (India): One of India's largest pharmaceutical companies, Sun Pharma produces omeprazole API through its extensive manufacturing network.
• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A major Chinese pharmaceutical company with significant API production capabilities, including omeprazole. Hisun supplies to regulated markets globally.
• Jiangsu Hengrui Medicine Co., Ltd. (China): Another substantial Chinese pharmaceutical manufacturer with a broad API portfolio, including omeprazole.
• Cipla Ltd. (India): A well-established Indian pharmaceutical company that manufactures omeprazole API, supplying both generic and branded markets.
• Dr. Reddy's Laboratories Ltd. (India): A diversified global pharmaceutical company with significant API manufacturing operations, including omeprazole.
• Teva Pharmaceutical Industries Ltd. (Israel): While primarily known for its generic FDFs, Teva also has API manufacturing capabilities and is a significant player in the omeprazole market.

Significant FDF Suppliers

These companies are major suppliers of finished omeprazole magnesium dosage forms:

• Teva Pharmaceutical Industries Ltd. (Israel): A leading global generic drug manufacturer, Teva offers various omeprazole magnesium formulations.
• Mylan N.V. (now part of Viatris) (USA): Historically, Mylan was a substantial supplier of generic omeprazole products.
• Sun Pharmaceutical Industries Ltd. (India): Offers finished omeprazole magnesium products in multiple markets.
• Apotex Inc. (Canada): A significant generic pharmaceutical company with omeprazole magnesium products in its portfolio.
• Lupin Ltd. (India): Provides omeprazole magnesium finished dosage forms globally.
• AstraZeneca Plc. (UK): The originator company for omeprazole (Prilosec/Losec), AstraZeneca continues to market branded omeprazole products in some regions.
• Sandoz (Switzerland): The generics division of Novartis, Sandoz, is a major supplier of generic omeprazole magnesium.
• Gilead Sciences, Inc. (USA): While not a primary omeprazole manufacturer, Gilead may be involved in specific regional markets or through acquisitions.

What Are the Regulatory and Quality Standards for Omeprazole Magnesium Production?

Compliance with stringent regulatory standards is paramount for suppliers of omeprazole magnesium. Key regulatory bodies and their requirements influence manufacturing practices, quality control, and market access.

• U.S. Food and Drug Administration (FDA): Requires Good Manufacturing Practices (GMP) compliance, detailed drug master files (DMFs), and adherence to pharmacopeial standards (USP). Inspections of manufacturing facilities are routine.
• European Medicines Agency (EMA): Mandates compliance with EU GMP guidelines, submission of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs), and site inspections.
• Pharmaceuticals and Medical Devices Agency (PMDA) - Japan: Implements strict GMP requirements and product registration processes.
• Central Drugs Standard Control Organisation (CDSCO) - India: Oversees drug manufacturing and quality within India, with its own GMP guidelines.
• National Medical Products Administration (NMPA) - China: Regulates drug manufacturing in China.

Key Quality Certifications and Compliance Metrics

Suppliers typically hold certifications demonstrating adherence to international quality standards.

Certification/Standard	Description	Importance for Omeprazole Magnesium
Good Manufacturing Practices (GMP)	A system for ensuring that products are consistently produced and controlled according to quality standards.	Essential for API and FDF manufacturing to guarantee safety, efficacy, and purity of omeprazole magnesium.
US FDA Registration/Inspection	Successful FDA inspections and site registrations for manufacturing facilities and APIs.	Crucial for market access to the United States.
EMA Certification/CEP	Certificates of Suitability (CEP) issued by the European Directorate for the Quality of Medicines & Health (EDQM) or equivalent GMP compliance.	Required for API supply to European Union member states.
ICH Guidelines	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines (e.g., Q7 for APIs).	Provides a harmonized framework for quality, safety, and efficacy, facilitating global market acceptance.
ISO Certifications	ISO 9001 (Quality Management), ISO 14001 (Environmental Management).	Demonstrates a commitment to overall operational excellence and environmental responsibility.
Drug Master Files (DMFs)	Confidential detailed information submitted to regulatory authorities regarding manufacturing processes, facilities, and controls.	Essential for API suppliers to support FDF manufacturers' marketing applications.

What is the Global Production Capacity and Market Dynamics for Omeprazole Magnesium?

The production capacity for omeprazole magnesium API is substantial, driven by the high global demand for generic omeprazole products. Market dynamics are influenced by price competition, regulatory changes, and supply chain stability.

Estimated Global API Production Capacity

Estimates suggest a global API production capacity for omeprazole magnesium in the range of 1,000 to 1,500 metric tons per year. This figure is subject to fluctuations based on active plant utilization and new capacity additions.

• China: Holds a significant share of this capacity, estimated at 40-50%.
• India: Accounts for another substantial portion, estimated at 30-40%.
• Other Regions (Europe, North America): Contribute the remaining 10-20%, often focusing on specialized grades or meeting specific regional regulatory requirements.

Market Trends and Influences

• Generic Competition: The market is highly competitive due to the expiration of patents for the originator product. This drives down prices and places a premium on cost-efficient manufacturing.
• Supply Chain Volatility: Geopolitical events, raw material shortages, and shipping disruptions can impact the availability and cost of omeprazole magnesium. Companies with diversified supply chains and backward integration are better positioned.
• Regulatory Scrutiny: Increased regulatory oversight from agencies like the FDA and EMA on API quality and manufacturing processes can lead to supply disruptions if suppliers fail inspections.
• Emerging Markets: Growing healthcare access in developing nations contributes to sustained demand for affordable omeprazole magnesium products.
• Product Formulations: Demand for various dosage forms (e.g., enteric-coated capsules, delayed-release tablets) requires manufacturers to offer diverse formulation capabilities.

What Are the Key Considerations for Sourcing Omeprazole Magnesium?

Strategic sourcing of omeprazole magnesium requires a comprehensive evaluation of suppliers based on several critical factors to ensure reliability, quality, and cost-effectiveness.

Supplier Evaluation Criteria

• Regulatory Compliance: Verify current GMP certifications, FDA/EMA approvals, and a history of successful regulatory inspections. Request access to relevant DMFs and CEPs.
• Quality Assurance: Assess the supplier's Quality Management System (QMS), including batch-to-batch consistency, impurity profiling, and stability data.
• Production Capacity and Reliability: Evaluate the supplier's demonstrated capacity and their track record for on-time delivery. Understand their business continuity plans for potential disruptions.
• Cost Competitiveness: While quality and reliability are paramount, pricing remains a significant factor in the generic drug market.
• Technical Support: The ability of the supplier to provide technical assistance, including analytical method support and troubleshooting, is valuable.
• Supply Chain Transparency: Understand the supplier's raw material sourcing and their own supply chain resilience.
• Intellectual Property: Ensure that the supplier operates without infringing on any existing patents, particularly for any novel manufacturing processes.

Supplier Performance Metrics

• On-Time Delivery Rate: Target a rate above 95%.
• Quality Complaint Rate: Aim for less than 1% of batches.
• Regulatory Audit Pass Rate: Maintain a 100% pass rate for major regulatory bodies.
• Lead Time: Establish acceptable lead times for API orders, typically 6-12 weeks depending on order volume.

Key Takeaways

The global omeprazole magnesium market is dominated by API and FDF manufacturers in India and China, driven by cost advantages and established infrastructure. Regulatory compliance with GMP, FDA, and EMA standards is non-negotiable for market access and product integrity. Key suppliers include Aarti Drugs, Divi's Laboratories, Lupin, Sun Pharma, Zhejiang Hisun, and Teva Pharmaceuticals. Strategic sourcing necessitates a thorough evaluation of regulatory standing, quality systems, production capacity, and cost. The market is characterized by intense generic competition, demanding efficient and reliable supply chains.

Frequently Asked Questions

• What are the primary chemical synthesis routes for omeprazole magnesium? The synthesis typically involves the cyclization of a substituted pyridine derivative with a mercaptobenzimidazole derivative, followed by oxidation and salt formation with magnesium. Specific patented routes may exist for improved yield or purity.
• How does omeprazole magnesium differ from omeprazole sodium? Omeprazole magnesium is a salt form of omeprazole, as is omeprazole sodium. The choice of salt form can influence solubility, stability, and pharmacokinetic properties, though both are used interchangeably in many formulations.
• What is the typical shelf life of omeprazole magnesium API? The typical shelf life for omeprazole magnesium API, when stored under recommended conditions, is generally between 2 to 3 years. Specific shelf life is determined by the manufacturer's stability studies.
• Are there any environmental concerns associated with omeprazole magnesium manufacturing? As with all chemical synthesis, manufacturing processes can generate chemical waste. Responsible manufacturers implement waste treatment protocols and adhere to environmental regulations (e.g., ISO 14001) to mitigate environmental impact.
• What is the role of excipients in omeprazole magnesium finished dosage forms? Excipients are inactive ingredients that are crucial for formulation. For omeprazole magnesium, common excipients include fillers (e.g., microcrystalline cellulose), binders (e.g., povidone), disintegrants (e.g., crospovidone), lubricants (e.g., magnesium stearate), and enteric coating polymers (e.g., methacrylic acid copolymers) to protect the acid-labile omeprazole from stomach acid.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [FDA website] (Note: Specific URL for GMP guidance changes; users should navigate the FDA site for current information).

[2] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [EMA website] (Note: Specific URL for GMP guidance changes; users should navigate the EMA site for current information).

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH website] (Note: Specific URL for ICH guidelines changes; users should navigate the ICH site for current information).

[4] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from [EDQM website] (Note: Specific URL for CEP information changes; users should navigate the EDQM site for current information).