OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	209281	ANDA	Accord Healthcare Inc.	16729-366-15	90 TABLET, FILM COATED in 1 BOTTLE (16729-366-15)	2020-09-21
Accord Hlthcare	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	209281	ANDA	Accord Healthcare Inc.	16729-367-15	90 TABLET, FILM COATED in 1 BOTTLE (16729-367-15)	2020-09-03
Accord Hlthcare	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	209281	ANDA	Accord Healthcare Inc.	16729-368-15	90 TABLET, FILM COATED in 1 BOTTLE (16729-368-15)	2020-09-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for antihypertensive medications such as Olmesartan Medoxomil and Hydrochlorothiazide is dynamic, involving a complex web of manufacturers, suppliers, and distributors. Both drugs are widely prescribed, often in combination therapies, to manage hypertension and related cardiovascular conditions. Securing reliable suppliers is a critical component for pharmaceutical companies, healthcare providers, and distributors seeking to ensure medication availability, quality, and affordability.

This article offers a comprehensive overview of leading suppliers for Olmesartan Medoxomil and Hydrochlorothiazide, examining manufacturing companies, regional manufacturing footprints, regulatory approvals, and considerations for procurement strategies.

Olmesartan Medoxomil: Overview and Supplier Landscape

Olmesartan Medoxomil is an angiotensin II receptor blocker (ARB) prescribed primarily for hypertension and stroke prevention. Since its introduction, numerous Generic and branded formulations have entered the global market, supported by a diverse supplier base.

Key Manufacturers and Suppliers

Boehringer Ingelheim
- Original innovator of Olmesartan (brand name: Benicar)
- Supplies specified formulations in North America and select regions
- Focuses on maintaining high-quality standards and patent protection until patent expiry (around 2014 in many markets)
Teva Pharmaceutical Industries
- One of the largest generic drug manufacturers globally
- Supplies generic Olmesartan Medoxomil in extensive markets, including North America and Europe
- Recognized for large-scale manufacturing capabilities and extensive distribution channels
Mylan (now part of Viatris)
- A major supplier of generics, including Olmesartan Medoxomil
- Offers competitive pricing and broad regional availability
- Ensures quality compliance through stringent regulatory standards
Sandoz (a Novartis division)
- Provides generic versions across various markets
- Has established robust supply chains in Europe and emerging markets
Hetero Drugs, Dr. Reddy’s Laboratories, and Lupin
- Prominent Indian generic manufacturers supplying Olmesartan Medoxomil globally
- Known for cost-effective manufacturing and adherence to international quality standards, such as WHO-GMP

Regional Manufacturing and Distribution

India and China serve as primary manufacturing hubs for generic Olmesartan Medoxomil, driven by low-cost production costs and large-scale facilities. European and North American markets rely on a combination of local manufacturing and imported generics, often tested and regulated by agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional authorities.

Regulatory and Quality Considerations

Suppliers must meet stringent regulatory approvals. The US, European, and Japanese authorities require rigorous Good Manufacturing Practice (GMP) Compliance, with batch testing and bioequivalence studies. Certificate of Suitability (CEPs) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) also validate quality standards, especially for imports into Europe.

Hydrochlorothiazide: Overview and Supplier Landscape

Hydrochlorothiazide (HCTZ) is a thiazide diuretic used to treat hypertension and edema. It remains one of the most prescribed diuretics worldwide, with a vast supplier network supporting its consistent supply.

Leading Manufacturers and Suppliers

Mitsubishi Tanabe Pharma Corporation
- Provides high-quality HCTZ, mainly for the Asian markets
- Maintains rigorous manufacturing standards and regulatory compliance
Sagent Pharmaceuticals
- Supplies both active pharmaceutical ingredients (APIs) and finished formulations in North America
- Focuses on sterile and non-sterile generics, including HCTZ
Hikma Pharmaceuticals
- Offers consistent supply of Hydrochlorothiazide APIs and formulations globally
- Recognized for quality and regulatory adherence
Sun Pharma
- One of India's largest pharmaceutical companies producing HCTZ APIs and generics for global markets
- Combines affordability with reliable supply chains
Lupin and Aurobindo Pharma
- Key Indian API manufacturers and finished drug suppliers
- Strong manufacturing infrastructure supporting both APIs and finished dosage forms

Regional Manufacturing Dynamics

India accounts for the majority of HCTZ API production, supported by robust manufacturing infrastructure and cost advantages. China also supplies significant quantities of bulk API, often exported globally. Regulatory standards vary, with many suppliers complying with US FDA and EMA GMP guidelines, especially those exporting to regulated markets.

Quality Assurance and Regulatory Entry

Suppliers must provide comprehensive documentation, including ISO certifications, GMP compliance certificates, and stability data. For brands targeting North America and Europe, FDA and EMA approvals are essential. Importers often require Certificates of Analysis (CoA) verifying quality and potency.

Supply Chain Challenges and Opportunities

Market demand for Olmesartan Medoxomil and Hydrochlorothiazide remains steady due to their cost-effectiveness and efficacy. However, supply chain vulnerabilities—such as geopolitical issues, regulatory delays, and raw material shortages—pose risks.

Diversification of supplier sources and regional manufacturing are strategic approaches to mitigate risks. Emphasizing suppliers with established regulatory compliance, high-quality standards, and scalable production capacities ensures a resilient supply chain.

Strategic Sourcing Considerations

Regulatory Compliance: Prioritize suppliers with validated GMP standards and regional regulatory approvals to minimize compliance risks.
Quality Certifications: Verify ISO, WHO-GMP, or FDA certification to ensure consistent quality.
Cost-effectiveness: Balance price competitiveness with manufacturing reliability to optimize procurement budgets.
Supply Chain Flexibility: Develop relationships with multiple suppliers across different regions to prevent shortages.
Traceability: Maintain transparent supply chain traceability from raw material sourcing to final product distribution.

Conclusion

The supply of Olmesartan Medoxomil and Hydrochlorothiazide depends on a global network of reputable manufacturers and suppliers, predominantly based in India, China, and Western markets. Strategic procurement involves thorough evaluation of regulatory statuses, quality certifications, and manufacturing capacity. As the market evolves, companies that diversify their supplier base and prioritize high standards will better navigate supply chain disruptions, ensuring sustained access to these vital medications.

Key Takeaways

Leading suppliers for Olmesartan Medoxomil include Boehringer Ingelheim (innovator), Teva, Mylan, Sandoz, and Indian manufacturers such as Lupin and Dr. Reddy's.
Hydrochlorothiazide is primarily supplied by Indian manufacturers (Sun Pharma, Lupin) and international players (Hikma, Mitsubishi).
Regional manufacturing hubs in India and China dominate production, with stringent regulatory oversight required for exports to regulated markets.
Regulatory adherence—through GMP and certifications—is critical for supplier qualification.
Supply chain resilience involves diversification, compliance verification, and fostering strategic supplier relationships.

FAQs

1. Who are the top global suppliers for Olmesartan Medoxomil?
The leading suppliers include Boehringer Ingelheim (original patent holder), Teva, Mylan (Viatris), Sandoz, and major Indian manufacturers like Lupin and Dr. Reddy’s.

2. Which countries dominate Hydrochlorothiazide production?
India and China are the primary producers of Hydrochlorothiazide API, supporting global demand with large-scale manufacturing facilities.

3. What quality standards should suppliers meet for regulated markets?
Suppliers should demonstrate compliance with GMP (Good Manufacturing Practice), hold certifications from agencies like the FDA, EMA, or WHO-GMP, and provide comprehensive documentation.

4. How can companies mitigate supply chain risks for these drugs?
Diversify suppliers across regions, prioritize quality and compliance, establish inventory buffers, and maintain transparent traceability practices.

5. Are there opportunities for new suppliers in this market?
Yes, particularly in emerging markets, where regulatory pathways are expanding, and the demand for cost-effective generics continues to grow, opening opportunities for qualified manufacturers.

References

[1] European Directorate for the Quality of Medicines & HealthCare (EDQM). Certificate of Suitability for Olmesartan Medoxomil.
[2] US Food and Drug Administration (FDA). Drug Approvals and Certification Reports for Hydrochlorothiazide.
[3] EvaluatePharma. Global Market Trends for Antihypertensive Medications.
[4] Indian Pharmaceutical Alliance. API Manufacturing Capabilities.
[5] World Health Organization (WHO). Good Manufacturing Practices Guidelines for APIs.

This comprehensive overview provides business professionals with the insights needed to streamline procurement strategies for Olmesartan Medoxomil and Hydrochlorothiazide, ensuring supply continuity and regulatory compliance in a competitive pharmaceutical market.

Suppliers and packagers for OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE