Suppliers and packagers for OMEPRAZOLE AND SODIUM BICARBONATE

OMEPRAZOLE AND SODIUM BICARBONATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228	ANDA	Ajanta Pharma USA Inc.	27241-031-03	30 CAPSULE in 1 BOTTLE (27241-031-03)	2016-07-15
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228	ANDA	Ajanta Pharma USA Inc.	27241-032-03	30 CAPSULE in 1 BOTTLE (27241-032-03)	2016-07-15
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228	ANDA	Direct_rx	72189-568-30	30 CAPSULE in 1 BOTTLE (72189-568-30)	2024-08-12
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228	ANDA	PHOENIX RX LLC	85509-1031-1	15 CAPSULE in 1 BOTTLE (85509-1031-1)	2016-07-15
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228	ANDA	PHOENIX RX LLC	85509-1031-3	30 CAPSULE in 1 BOTTLE (85509-1031-3)	2016-07-15
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228	ANDA	PHOENIX RX LLC	85509-1031-6	60 CAPSULE in 1 BOTTLE (85509-1031-6)	2016-07-15

Omeprazole and Sodium Bicarbonate Drug Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the global supply chain for Omeprazole and Sodium Bicarbonate, focusing on key suppliers, manufacturing capabilities, and patent landscape relevant to their production. The analysis identifies critical raw material providers, active pharmaceutical ingredient (API) manufacturers, and finished dosage form producers for these widely used gastrointestinal medications.

What is the Current Global Production Landscape for Omeprazole APIs?

The global production of Omeprazole API is dominated by manufacturers in Asia, primarily China and India, due to cost advantages and established chemical synthesis infrastructure. European and North American manufacturers also exist, often focusing on higher-purity grades or specialized formulations.

Key Omeprazole API Manufacturers by Region:

• China:
  • Hunan Huacheng Biotech, Inc.
  • Zhejiang NHU Co., Ltd.
  • Lupin Ltd. (manufacturing sites in China)
  • Jiangxi Kangsheng Pharmaceutical Co., Ltd.
• India:
  • Divi's Laboratories Limited
  • Dr. Reddy's Laboratories
  • Sun Pharmaceutical Industries Ltd.
  • Aurobindo Pharma
• Europe:
  • Sanofi S.A. (France)
  • Teva Pharmaceutical Industries Ltd. (multiple European sites)
• North America:
  • Mylan N.V. (now part of Viatris, Inc., with US manufacturing)
  • Pfizer Inc. (US manufacturing)

Production capacity varies significantly. Major players like Divi's Laboratories and Zhejiang NHU operate large-scale facilities capable of producing hundreds of metric tons annually. Smaller manufacturers cater to regional markets or specialized product requirements. Lead times for bulk API orders typically range from 4 to 12 weeks, depending on supplier inventory and production schedules. Pricing is competitive, with significant fluctuations influenced by raw material costs and global demand.

Who are the Primary Suppliers of Sodium Bicarbonate for Pharmaceutical Use?

Sodium Bicarbonate, a widely used excipient and active ingredient in certain formulations, is supplied by numerous global chemical manufacturers. Pharmaceutical-grade sodium bicarbonate must meet stringent purity standards (e.g., USP, EP, JP).

Major Pharmaceutical-Grade Sodium Bicarbonate Suppliers:

• North America:
  • Church & Dwight Co., Inc. (Arm & Hammer)
  • Solvay S.A. (US operations)
  • Tate & Lyle
• Europe:
  • Solvay S.A. (global presence, significant European production)
  • Tata Chemicals Europe
  • ICL Group
• Asia:
  • J.M. Huber Corporation (global supplier with Asian presence)
  • Weifang Shengxing Chemical Co., Ltd. (China)

These suppliers have dedicated production lines for pharmaceutical-grade products, ensuring compliance with Good Manufacturing Practices (GMP). Delivery times are generally shorter than for APIs, often within 2 to 6 weeks, due to the commodity nature and widespread production of sodium bicarbonate. Pricing is influenced by energy costs and raw material sourcing (salt, ammonia, carbon dioxide).

What is the Patent Status for Omeprazole and its Key Formulations?

The original patents for Omeprazole (e.g., the proton pump inhibitor mechanism) have long expired. However, patents continue to be filed and granted for new formulations, manufacturing processes, polymorphs, and combination therapies involving Omeprazole.

Key Patent Expiration Dates and Areas of Ongoing Patent Activity:

• Original Composition of Matter Patents: Expired in most major markets by the early to mid-2000s. For instance, US Patent 4,255,431, a foundational patent for Omeprazole, expired in the United States in 2003.
• Formulation Patents: Patents for specific delivery systems (e.g., enteric-coated tablets, delayed-release capsules, orally disintegrating tablets) have extended market exclusivity for certain products. Examples include patents for formulations designed for improved stability, faster onset of action, or enhanced patient compliance.
• Process Patents: Novel or improved methods for synthesizing Omeprazole or its intermediates are continuously patented. These can offer competitive advantages by reducing costs, increasing yields, or improving purity.
• Polymorph Patents: Discovery and patenting of new crystalline forms (polymorphs) of Omeprazole can offer distinct physical properties and may lead to new patent protection.
• Combination Therapy Patents: Patents may cover Omeprazole in combination with other active pharmaceutical ingredients, such as antibiotics for Helicobacter pylori eradication or with antacids.

Notable Patent Examples and Their Implications:

• Esomeprazole Patents: While Esomeprazole (the S-isomer of Omeprazole) is a distinct entity, its development and patenting (e.g., by AstraZeneca) significantly impacted the Omeprazole market. Key patents for Esomeprazole's enantiomerically pure form expired, allowing for generic competition.
• Orally Disintegrating Formulations: Patents covering ODT formulations have provided extended market protection for specific Omeprazole products. For example, patents related to specific binder or disintegrant systems for ODTs.
• Manufacturing Process Improvements: Patents filed by API manufacturers often focus on chiral separation techniques, improved crystallization methods, or impurity reduction. These can be critical for generic manufacturers seeking non-infringing processes.

The landscape is dynamic, with generic manufacturers actively seeking opportunities by challenging existing patents or developing non-infringing manufacturing routes.

How Does the Combined Use of Omeprazole and Sodium Bicarbonate Impact Formulation and Manufacturing?

The combination of Omeprazole and Sodium Bicarbonate presents specific formulation and manufacturing challenges and opportunities. Omeprazole is an acid-labile drug, meaning it degrades in acidic environments. Sodium Bicarbonate is an antacid that neutralizes stomach acid. This necessitates careful formulation to ensure Omeprazole's stability and efficacy.

Formulation Considerations:

• Delayed Release/Enteric Coating: Omeprazole formulations typically require enteric coating or other delayed-release mechanisms to protect the API from premature degradation by stomach acid. This coating dissolves in the higher pH environment of the small intestine, releasing the Omeprazole.
• pH Modulation: When Sodium Bicarbonate is co-formulated or taken concurrently, it raises the stomach's pH. This can potentially affect the dissolution profile of the enteric coating if not properly designed. Manufacturers must ensure the coating remains intact until it reaches the small intestine.
• Excipient Compatibility: Interactions between Omeprazole, Sodium Bicarbonate, and other excipients (binders, fillers, disintegrants) must be thoroughly evaluated to prevent degradation or altered dissolution characteristics.
• Dosage Form: Combinations can be presented as:
  • Fixed-dose combination products: Where both APIs are in a single dosage unit (e.g., a tablet with a delayed-release Omeprazole core and an immediate-release Sodium Bicarbonate outer layer, or granules within a capsule).
  • Co-packaged products: Separate Omeprazole dosage forms and Sodium Bicarbonate (e.g., powder for suspension or chewable tablets) packaged together.
  • Concurrent administration: Patients are instructed to take separate products at specific times.

Manufacturing Considerations:

• Granulation and Coating: For fixed-dose combination tablets or granules, processes like wet granulation, dry granulation, or fluid bed granulation are employed. Precise control over coating parameters (e.g., polymer type, spray rate, temperature) is critical for enteric coating.
• Segregation of APIs: In certain combination designs, physical separation within the dosage unit is necessary to prevent direct interaction between Omeprazole and Sodium Bicarbonate before administration.
• Equipment Cleaning: Thorough cleaning procedures are essential between batches, especially when handling different drug substances, to prevent cross-contamination.
• Stability Testing: Extensive stability studies under various conditions (temperature, humidity) are required to confirm the shelf-life and integrity of the combined product. This includes monitoring API degradation, dissolution rates, and physical characteristics.

Example of a Combined Product Approach:

A common approach for prescription products involves a delayed-release capsule or tablet containing Omeprazole pellets, and separate packets of effervescent granules containing Sodium Bicarbonate and other agents (e.g., flavoring, citric acid) that are dissolved in water for concurrent administration. This allows for optimized formulation of each component.

What are the Regulatory Hurdles for Omeprazole and Sodium Bicarbonate Products?

Regulatory approval for Omeprazole and Sodium Bicarbonate products, whether as single agents or combinations, involves navigating a complex global framework. Key agencies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Key Regulatory Aspects:

• Active Substance Master Files (ASMFs) / Drug Master Files (DMFs): API manufacturers must maintain DMFs that contain detailed information about the manufacturing process, quality control, and stability of their APIs. These are submitted to regulatory agencies for review when a drug product application is filed.
• Good Manufacturing Practices (GMP): All manufacturing facilities for both APIs and finished drug products must adhere to strict GMP guidelines. Regular inspections by regulatory authorities ensure compliance.
• ANDA / NDA / MAA Filings:
  • Abbreviated New Drug Application (ANDA): For generic Omeprazole products, manufacturers must demonstrate bioequivalence to the reference listed drug (RLD).
  • New Drug Application (NDA) / Marketing Authorisation Application (MAA): For novel formulations, combination products, or new indications, extensive clinical trial data demonstrating safety and efficacy is required.
• Impurity Profiling: Rigorous analysis and control of impurities, including process-related impurities and degradation products, are mandatory. Specific limits are set by pharmacopoeias (e.g., USP, EP) and regulatory agencies.
• Pharmacopoeial Compliance: Products must meet the specifications outlined in the relevant pharmacopoeias for identity, purity, assay, and dissolution.
• Labeling and Packaging: Regulations dictate the content of product labeling, including indications, dosage, warnings, and contraindications. Packaging must ensure product stability and prevent adulteration.
• Bioequivalence Studies: For generic Omeprazole, demonstration of bioequivalence to an already approved product is a critical step. Studies measure the rate and extent of drug absorption in healthy volunteers.
• Stability Data: Comprehensive stability data supporting the proposed shelf-life of the drug product under defined storage conditions is essential.

The regulatory process for a generic Omeprazole product is generally streamlined compared to a novel combination. However, for any product involving Sodium Bicarbonate, especially in combination with an acid-labile drug like Omeprazole, demonstrating the stability and consistent performance of the enteric coating or release mechanism under varying physiological pH conditions is paramount.

What is the Market Outlook for Omeprazole and Combined Therapies?

The market for Omeprazole as a standalone generic is mature and highly competitive, with significant price erosion. However, the market for combination therapies, particularly those addressing complex gastrointestinal disorders or improving patient adherence, shows continued growth.

Market Trends and Projections:

• Generic Omeprazole Market: Characterized by high volume, low margins, and intense competition among API and finished dosage form manufacturers. Growth is primarily driven by population growth and increased access in emerging markets.
• Proton Pump Inhibitor (PPI) Market Growth: The broader PPI market, which Omeprazole and Esomeprazole are part of, is expected to continue growing due to the prevalence of GERD, peptic ulcers, and H. pylori infections.
• Combination Therapies: Demand for fixed-dose combinations that simplify treatment regimens for conditions like H. pylori eradication (Omeprazole + Antibiotics) is a key growth driver. These combinations improve patient compliance and potentially therapeutic outcomes.
• New Formulations: Development of improved formulations (e.g., faster-acting, longer-acting, or patient-convenient forms like orally disintegrating tablets) can create niche markets and command premium pricing.
• Regulatory Landscape Impact: Evolving regulatory requirements and the increasing focus on drug quality and impurity control can influence market dynamics, favoring manufacturers with robust quality systems.
• Emerging Markets: Significant growth potential exists in Asia-Pacific, Latin America, and Africa as healthcare access expands and generic drug adoption increases.

Competitive Landscape:

The market for generic Omeprazole API and finished dosage forms is populated by a large number of global players, with Indian and Chinese manufacturers holding a substantial share. Key players in branded and generic markets include AstraZeneca, Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories, and Aurobindo Pharma.

The market for Sodium Bicarbonate is characterized by a fragmented supply chain with large chemical producers serving multiple industries. Pharmaceutical-grade Sodium Bicarbonate suppliers are a subset of these, focusing on high purity and regulatory compliance.

Overall, while the pure generic Omeprazole market faces pricing pressures, the strategic development and marketing of innovative formulations and combination therapies offer opportunities for sustained growth and profitability.

Key Takeaways

• Omeprazole API production is concentrated in China and India, with significant global players in these regions.
• Pharmaceutical-grade Sodium Bicarbonate is supplied by a global network of chemical manufacturers with dedicated GMP-compliant facilities.
• While foundational Omeprazole patents have expired, ongoing patent activity focuses on novel formulations, manufacturing processes, and combination therapies.
• The acid-labile nature of Omeprazole necessitates advanced formulation techniques like enteric coating, which require careful integration with Sodium Bicarbonate's acid-neutralizing properties.
• Regulatory compliance, including GMP adherence and bioequivalence demonstration (for generics), is critical for market entry.
• The generic Omeprazole market is mature and competitive, while combination therapies and novel formulations present growth opportunities.

Frequently Asked Questions

1. What is the typical shelf-life for an Omeprazole delayed-release capsule? The typical shelf-life for an Omeprazole delayed-release capsule is 24 to 36 months when stored at controlled room temperature, according to manufacturer specifications.

2. Can Sodium Bicarbonate be taken at the same time as Omeprazole tablets? While it is generally not recommended to take immediate-release Sodium Bicarbonate simultaneously with standard Omeprazole tablets due to potential degradation of Omeprazole, specific co-formulated products or doctor-recommended staggered administration schedules exist.

3. What are the primary quality control tests for pharmaceutical-grade Sodium Bicarbonate? Primary quality control tests include assay for Sodium Bicarbonate content, identification, limits for heavy metals, arsenic, chloride, sulfate, and loss on drying, as per pharmacopoeial standards like USP or EP.

4. Are there any bioequivalence issues specific to Omeprazole and Sodium Bicarbonate combination products? Bioequivalence for combination products is complex. If it's a fixed-dose combination, bioequivalence must be demonstrated for the combination. If taken concurrently, the effect of Sodium Bicarbonate on Omeprazole's absorption profile needs to be considered in the overall efficacy assessment.

5. Which regulatory agencies have the strictest requirements for impurity levels in Omeprazole API? The U.S. FDA, EMA, and PMDA are generally considered to have the strictest requirements for impurity profiling and control in APIs, often setting lower permissible limits for genotoxic or potentially harmful impurities.

Cited Sources

[1] U.S. Food and Drug Administration. (n.d.). Patent Term Restoration and Exclusivity. Retrieved from [FDA website on patents] [2] European Medicines Agency. (n.d.). Medicines: Legislation. Retrieved from [EMA website on legislation] [3] United States Pharmacopeia. (2023). United States Pharmacopeia National Formulary (USP 46) [Online]. U.S. Pharmacopeial Convention. [4] European Pharmacopoeia. (2023). Ph. Eur. Online. European Directorate for the Quality of Medicines & HealthCare. [5] Various Pharmaceutical Company Product Information Inserts and Public Filings. (Data compiled from publicly available sources, e.g., company websites, regulatory submission databases). [6] Market Research Reports on the Global Pharmaceutical API Market and PPI Market. (Specific reports vary by provider, e.g., Grand View Research, Mordor Intelligence).