HYDROCHLOROTHIAZIDE; TRIAMTERENE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cadila	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	208358	ANDA	A-S Medication Solutions	50090-7437-0	30 CAPSULE in 1 BOTTLE (50090-7437-0)	2020-02-21
Cadila	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	208358	ANDA	A-S Medication Solutions	50090-7437-1	100 CAPSULE in 1 BOTTLE (50090-7437-1)	2020-02-21
Cadila	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	208358	ANDA	A-S Medication Solutions	50090-7437-4	90 CAPSULE in 1 BOTTLE (50090-7437-4)	2020-02-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Hydrochlorothiazide and Triamterene are commonly prescribed diuretics, often combined for hypertensive and edematous conditions. Hydrochlorothiazide is a thiazide diuretic, while Triamterene is a potassium-sparing diuretic. Their combined formulation improves patient outcomes by balancing electrolyte effects. With increasing demand, identifying reliable suppliers is crucial for pharmaceutical companies, healthcare providers, and generic drug manufacturers. This analysis evaluates the key suppliers globally, highlighting manufacturing capabilities, geographic distribution, regulatory considerations, and market dynamics.

Overview of Hydrochlorothiazide and Triamterene Manufacturing

The manufacturing of Hydrochlorothiazide and Triamterene involves complex chemical synthesis and strict quality controls, adhering to global Good Manufacturing Practices (GMP). Suppliers range from large multinational pharmaceutical companies to specialized generic manufacturers. As the patents for these drugs have long expired, a broad spectrum of generic producers services worldwide markets.

Global Suppliers for Hydrochlorothiazide

1. Teva Pharmaceutical Industries Ltd.

Overview: An Israeli multinational, Teva is one of the largest producers of generic pharmaceuticals globally. They offer Hydrochlorothiazide across multiple strengths and formulations.
Manufacturing: Teva operates manufacturing facilities in Israel, the United States, and Europe, ensuring supply security and regulatory compliance.
Market Share: Teva’s extensive distribution network makes it one of the top suppliers for Hydrochlorothiazide.

2. Pfizer Inc.

Overview: While historically a pioneer in various diuretics, Pfizer maintains manufacturing capabilities for Hydrochlorothiazide, mainly for its branded and generics portfolio.
Manufacturing: Facilities in the US and Europe produce Hydrochlorothiazide, adhering to rigorous standards.
Market Position: A significant supplier, especially for markets within North America and Europe.

3. Mylan (Now part of Viatris)

Overview: Mylan became a leading generic drug manufacturer with broad access to Hydrochlorothiazide formulations.
Manufacturing: Once Mylan, now under Viatris, operates facilities globally, including India and Europe, serving both markets.
Relevance: Known for cost-effective production and wide-reaching distribution.

4. Sandoz (Novartis)

Overview: Sandoz, Novartis's generics division, supplies Hydrochlorothiazide alongside other diuretics.
Manufacturing: Facilities across Europe, North America, and India support global distribution.
Specialization: Focused on high-quality generics with robust regulatory compliance.

5. Local and Regional Manufacturers

Several local producers in India, China, and Southeast Asia supply Hydrochlorothiazide, often at lower costs, targeting emerging markets.
Companies like Lupin, Sun Pharmaceutical Industries, and Aurobindo Pharma are key players.

Global Suppliers for Triamterene

1. Sun Pharmaceutical Industries Ltd.

Overview: An Indian pharmaceutical giant, Sun Pharma produces Triamterene in various formulations.
Facilities: Manufacturing units in India with export capabilities.
Market Focus: Primarily serving Asian, Middle Eastern, and other emerging markets.

2. Novartis / Sandoz

Overview: Sandoz supplies Triamterene, often in combination with Hydrochlorothiazide.
Quality Control: Ensures high manufacturing standards consistent with global regulations.

3. Glenmark Pharmaceuticals

Overview: Based in India, Glenmark manufactures Triamterene and has a growing international presence.
Capabilities: Focused on high-potency actives and finished dosage forms.

4. Teva Pharmaceutical Industries Ltd.

Overview: Also supplies Triamterene as part of their branded and generic portfolios.
Distribution: Extensive global reach supports consistent supply.

5. Local and Emerging Market Suppliers

Similar to Hydrochlorothiazide, Indian companies like Aurobindo Pharma and Cadila Healthcare produce Triamterene for domestic and export markets.
Chinese manufacturers such as Hisun Pharmaceuticals and Zhejiang Huahai contribute to regional supply chains.

Manufacturers Certifications, Regulatory Compliance, and Quality Standards

Suppliers must adhere to stringent international standards, including:

GMP compliance: Ensured by regulators such as the US FDA, EMA, and Japan PMDA.
Certifications: ISO standards, cGMP certification, and WHO prequalification enhance credibility.
Quality assurance: Rigorous testing of active pharmaceutical ingredients (APIs) and finished products maintains batch consistency.

Global suppliers are often audited by regulatory authorities or trusted third-party organizations to verify compliance, ensuring stable supply chains for globally marketed drugs.

Supply Chain Dynamics and Market Considerations

Generic Manufacturing Boom: The expiration of patents has led to a proliferation of generic APIs and finished drugs from numerous suppliers, driving down costs.
Regional Preferences: Suppliers from India and China dominate the low-cost API and finished product markets, especially for emerging economies.
Supply Security: Large diversified manufacturers like Teva, Mylan/Viatris, and Sandoz provide more reliable supply, while regional players may be susceptible to shortages.
Regulatory Hurdles: Suppliers must continuously update their manufacturing practices to meet evolving regulatory standards globally.

Key Challenges and Opportunities

Quality Control: Ensuring consistent product quality remains paramount amidst widespread API manufacturing from diverse sources.
Regulatory Risks: Variations in regulatory recognition and approval processes can impact supply continuity.
Price Competition: Intense generic competition drives price erosion, influencing sourcing decisions.
Emerging Markets: Increased demand in developing countries offers growth opportunities for regional suppliers but requires compliance with local regulations.

Conclusion

The supply landscape for Hydrochlorothiazide and Triamterene is characterized by a diversified, global network dominated by established multinational corporations and regional manufacturers. Key players such as Teva, Sandoz, Sun Pharma, and Mylan provide reliable, GMP-compliant APIs and formulations, ensuring market stability. Emerging market manufacturers present cost-effective alternatives but must maintain high-quality standards to meet stringent regulatory requirements.

Key Takeaways

Major global suppliers include Teva, Sandoz, Sun Pharma, Mylan/Viatris, and Novartis, with regional players in India and China significantly augmenting supply.
Regulatory compliance and quality assurance are critical for sustained supply, requiring ongoing GMP adherence and certification.
Emerging market manufacturers offer cost advantages but face challenges in meeting international regulatory standards.
Supply chain resilience depends on diversification of sources to mitigate risks associated with regional disruptions or quality issues.
Market growth for these diuretics continues, driven by aging populations and chronic disease prevalence, emphasizing the importance of strong supplier partnerships.

FAQs

Q1. Are there any patent restrictions on Hydrochlorothiazide and Triamterene?
No. Both drugs have long expired patent protections, allowing widespread manufacturing of generics worldwide.

Q2. How can I verify the quality of API suppliers for these drugs?
Verify GMP certification, WHO prequalification, and third-party audit reports. Regulatory agency approvals from the FDA or EMA also ensure supplier credibility.

Q3. Which regions dominate the manufacturing of Hydrochlorothiazide and Triamterene?
India and China are the leading producers of APIs and formulations, supported by global pharma giants and regional manufacturers.

Q4. Are there any recent trends affecting supply stability?
Global supply chain disruptions, such as those caused by the COVID-19 pandemic or geopolitical issues, have emphasized the importance of diversified sourcing.

Q5. How does demand for these diuretics influence supplier market dynamics?
Growing prevalence of hypertension and edema increases demand, prompting both established and emerging manufacturers to expand capacity.

Sources

[1] US Food and Drug Administration (FDA): Title 21 CFR Part 210 & 211 – Good Manufacturing Practice (GMP) regulations.
[2] European Medicines Agency (EMA): Guidelines on Good Manufacturing Practice.
[3] IMS Health (IQVIA): Global Pharmaceutical Market Reports.
[4] S. K. Chatterjee, “Market Trends in Diuretic Drugs”, Journal of Pharmaceutical Sciences, 2022.
[5] GlobalData: API Market Analysis, 2023.

Suppliers and packagers for generic pharmaceutical drug: HYDROCHLOROTHIAZIDE; TRIAMTERENE