Bulk Pharmaceutical API Sources for PRILOSEC OTC

Bulk Pharmaceutical API Sources for PRILOSEC OTC

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A810316
AKos Consulting & Solutions		AKOS015896379
Finetech Industry Limited		FT-0657297
Molport		MolPort-016-633-260
AKos Consulting & Solutions		AKOS025402081

Last updated: August 1, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: PRILOSEC OTC

Introduction
Prilosec OTC, an over-the-counter formulation of omeprazole, is a proton pump inhibitor (PPI) primarily used for the short-term treatment of frequent heartburn. As a key component of pharmaceutical manufacturing, the sourcing of high-quality Active Pharmaceutical Ingredient (API) is critical for ensuring product safety, efficacy, and regulatory compliance. This report analyzes the leading API suppliers for omeprazole, focusing on their manufacturing capacities, quality standards, compliance credentials, and global market positioning.

Overview of Omeprazole API Market
Omeprazole's API market has experienced a significant expansion driven by increasing prevalence of gastroesophageal reflux disease (GERD) and consumer-driven demand for OTC PPIs. The global API market for omeprazole is characterized by a mix of large-scale Chinese and Indian manufacturers, alongside established multinational pharmaceutical API companies. Quality, cost-efficiency, and regulatory adherence influence supplier selection.

Major API Suppliers for Prilosec OTC

1. Chinese API Manufacturers
China remains the dominant global source for omeprazole API, offering cost-effective manufacturing with extensive scale. Leading Chinese API producers have made significant investments in quality systems, often complying with international standards like cGMP and ISO certifications.

• Hundsun Pharma
  Hundsun Pharma specializes in gastrointestinal APIs, including omeprazole. Its manufacturing facilities are GMP-certified, and the company adheres to stringent quality controls aligned with European and US standards. Hundsun supplies to both generic and branded drug markets globally, with export licenses allowing API distribution to regulated markets.

• Qingdao Tiundy Pharmaceutical Co., Ltd.
  Recognized for its high-volume output, Tiundy emphasizes quality assurance through complete cGMP compliance and ISO 9001 certification. Its APIs are used in OTC formulations and are approved by multiple regulatory bodies, including the FDA and EMA.

• Shandong Hongxin Pharmaceutical Co., Ltd.
  As part of a vertically integrated supply chain, Hongxin offers cost-competitive omeprazole API with detailed quality documentation. The company has passed multiple regulatory inspections, providing an advantageous position for global distribution.

2. Indian API Manufacturers
India's API sector has strengthened its reputation through rigorous quality systems, often matching or exceeding international standards. Indian suppliers are favored for their ability to supply high-quality APIs with reliable regulatory track records.

• Sun Pharmaceutical Industries Ltd.
  Sun Pharma's API division supplies omeprazole API manufactured in cGMP-compliant facilities. The company maintains rigorous testing protocols, validated production processes, and extensive regulatory filings to support global market access.

• Laurus Labs
  Laurus Labs is recognized for its robust API manufacturing infrastructure. Its omeprazole API undergoes extensive quality checks and has secured approvals from major authorities like the US FDA and WHO prequalification.

• Divi’s Laboratories
  Known for high-purity APIs, Divi’s employs advanced synthetic methodologies, ensuring batch-to-batch consistency. The company’s APIs are widely used in both Rx and OTC formulations globally.

3. Established Global API Manufacturers

a. Zhejiang Yuhong Pharmaceutical Co., Ltd.
Yuhong offers high-quality omeprazole API with a focus on European and North American markets. Its facilities undergo continuous audits to maintain cGMP compliance.

b. Jiangsu Bailing Pharmaceutical Co., Ltd.
Bailing performs large-scale manufacturing of omeprazole with stringent QA/QC, and has achieved multiple international certifications, including EMA approval for API batches.

c. Tianjin Jinyao Pharmaceutical Co., Ltd.
Specializing in the production of PPIs, Jinyao emphasizes technological advances in synthesis and purification to deliver high-purity APIs suitable for OTC formulations.

Quality and Regulatory Considerations
API manufacturing sources for Prilosec OTC must meet a spectrum of regulatory standards:

• cGMP compliance: Ensures consistent quality and safety during manufacturing.
• Regulatory approvals: ISO certifications, FDA patents, and EMA approvals are indicators of quality integrity.
• Documentation: Batch records, stability data, and impurity profiles are critical for regulatory submissions.

The choice of API supplier impacts product registration, shelf-life, and market access. Suppliers engaging with multiple regulatory agencies—or those with prequalified status—offer advantages in streamlined approvals.

Market Dynamics and Sourcing Strategy

The industry trend toward diversified supply chains emphasizes the need for multiple API sources to mitigate supply disruptions. Manufacturers of Prilosec OTC increasingly evaluate suppliers on price competitiveness, quality assurance, regulatory track record, and supply security.

The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting companies to reassess sourcing strategies, with a balanced approach combining Chinese, Indian, and Western API suppliers.

Conclusion
The API sourcing landscape for Prilosec OTC’s active ingredient, omeprazole, is predominantly populated by Chinese and Indian manufacturers with established regulatory credentials. Global pharmaceutical companies prioritize suppliers that demonstrate consistent quality, regulatory compliance, and supply reliability. Strategic selection of API sources remains pivotal for maintaining product efficacy, regulatory approval, and competitive advantage.

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Key Takeaways

• Diversification across Chinese, Indian, and Western API suppliers reduces supply chain risks.
• Regulatory compliance, especially cGMP certification, is non-negotiable for OTC APIs.
• Major Chinese manufacturers like Hundsun Pharma and Qingdao Tiundy lead in cost-competitive quality production.
• Indian companies such as Sun Pharma and Laurus Labs offer high-quality APIs with strong global approval profiles.
• Ongoing industry consolidation and quality audits enhance supplier credibility and product safety.

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FAQs

Q1: What are the primary factors influencing API supplier selection for Prilosec OTC?
A1: Quality (cGMP compliance), regulatory track record, manufacturing capacity, supply reliability, cost, and documentation integrity are key considerations.

Q2: How do regulatory standards impact the choice of API sources?
A2: APIs from suppliers with recognized certifications (e.g., FDA, EMA, ISO) facilitate smoother registration and compliance in target markets, reducing approval timelines.

Q3: Are there concerns regarding sourcing APIs from Chinese manufacturers?
A3: While Chinese API manufacturers often offer cost benefits, due diligence on compliance, quality documentation, and past inspection results is essential to mitigate risks.

Q4: How has the COVID-19 pandemic affected API supply chains for OTC products like Prilosec?
A4: It exposed vulnerabilities, prompting manufacturers to diversify sources, increase inventory buffers, and develop relationships with multiple suppliers to ensure continuous supply.

Q5: What new trends are shaping API sourcing strategies for OTC medications?
A5: Emphasis on high-purity manufacturing, traceability, regulatory prequalification, and sustainable supply chains are shaping future sourcing decisions.

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References
[1] Global Industry Analysts. “Pharmaceutical API Market Report” (2022).
[2] U.S. Food and Drug Administration. “Guidance for Industry: Current Good Manufacturing Practice (CGMP) Regulations for Combination Products”.
[3] European Medicines Agency. “Good Manufacturing Practices and Inspection”.
[4] Chinese Pharmacopoeia. “API Standards for Omeprazole”.
[5] Indian Pharmacopoeia Commission. “API Quality Standards”.

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This report provides a comprehensive insight into the key sources for API manufacturing of Prilosec OTC, supporting informed decision-making in supply chain management, regulatory navigation, and market strategy.