Suppliers and packagers for ALDACTAZIDE

ALDACTAZIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-188-02	100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)	2021-11-29

Supplier Landscape for ALDACTAZIDE: An In-Depth Patent and Market Analysis

Last updated: July 28, 2025

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Introduction

ALDACTAZIDE, a combination antihypertensive medication containing hydralazine and hydrochlorothiazide, remains integral in managing hypertension and edema. As market dynamics evolve, understanding its supplier ecosystem is crucial for manufacturers, healthcare providers, and investors aiming for strategic procurement, intellectual property navigation, and competitive positioning. This analysis delineates the current supplier landscape, patent considerations, manufacturing trends, and market opportunities surrounding ALDACTAZIDE.

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Product Overview and Therapeutic Significance

ALDACTAZIDE combines hydralazine, a direct-acting vasodilator, with hydrochlorothiazide, a thiazide diuretic, to achieve enhanced blood pressure control. Originally developed in the 1960s, its patent protections have long expired, leading to a proliferation of generic manufacturers. Nonetheless, its enduring clinical relevance sustains a diverse supplier base that competes on price, quality, and regulatory compliance.

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Patent and Intellectual Property Landscape

The original patents for ALDACTAZIDE and its individual components expired decades ago, with key innovations secured in the 20th century. The compound's primary patents no longer constrain manufacturing, opening the market to numerous generic producers. However, secondary patents related to specific formulations, delivery methods, or combination techniques could still pose barriers under certain jurisdictions, notably in regions with robust patent enforcement.

Implication: The absence of fundamental patents facilitates market entry but necessitates vigilance over secondary patents that may influence supplier selection.

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Current Suppliers and Market Participants

Generic Pharmaceutical Manufacturers

The generic landscape for ALDACTAZIDE is extensive, with numerous companies supplying both the combination drug and its active pharmaceutical ingredients (APIs). Major players include:

• Sandoz (Novartis): A global leader in generic medications, Sandoz supplies ALDACTAZIDE in multiple markets, leveraging its extensive API synthesis and manufacturing capabilities.

• Mylan (now part of Viatris): Historically a significant supplier, Mylan offers competitive pricing and scale, with manufacturing facilities adhering to WHO and FDA standards.

• Teva Pharmaceuticals: Known for its broad generic portfolio, Teva supplies ALDACTAZIDE, with manufacturing plants in Europe and North America ensuring supply continuity.

• India-based Manufacturers: Companies such as Sun Pharmaceutical Industries, Lupin, and Cadila Healthcare produce both the combination drug and APIs, often at lower cost, serving emerging markets and generic distribution channels globally.

• Chinese Manufacturers: Several Chinese firms manufacture APIs and finished dosage forms, focusing on cost-effective supply while meeting international regulatory standards.

Active Pharmaceutical Ingredient (API) Suppliers

APIs for hydralazine and hydrochlorothiazide are critical components, usually sourced from specialized intermediates producers:

• Aurobindo Pharma: Supplies high-quality APIs with global certifications, often supplying to major branded and generic companies.

• Hindustan Organic Chemicals: An Indian state-owned enterprise providing APIs compliant with international standards.

• Certis Pharmaceuticals: Supplies hydralazine APIs, with emphasis on purity and consistent manufacturing quality.

Formulation and Contract Manufacturing Organizations (CMOs)

Many suppliers leverage CMOs for finished product manufacturing, including facilities compliant with Good Manufacturing Practices (GMP):

• Patheon (Thermo Fisher Scientific): Offers contract manufacturing solutions, inclusive of finished dosage forms.

• Famar HealthCare Services: Provides formulation, packing, and distribution services, ensuring tailored supply chains.

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Market Entry Strategies and Barriers

Given the expiration of core patents, market entry primarily hinges on regulatory approvals and manufacturing capabilities rather than patent litigation. However, company-specific barriers include:

• Regulatory Compliance: Meeting FDA, EMA, PIC/S, and equivalent standards for APIs and finished products.

• Quality Assurance: Maintaining USP, EP, or JP quality standards to compete globally.

• Supply Chain Management: Ensuring reliable sources of high-quality APIs and maintaining consistent production schedules.

Regulatory Considerations and Global Trade

Different regulatory environments influence supplier viability:

• United States: FDA-registered facilities are preferred to meet stringent quality standards, with the Drug Establishment Registration mandatory.

• European Union: Enforcement of EMA regulations and compliance with the EU GMP directives.

• Emerging Markets: Stringent regulatory pathways vary, often permitting sourcing from certified Indian or Chinese manufacturers.

Emerging Trends and Opportunities

• Vertical Integration: Leading manufacturers increasingly control both API production and finished drug formulations to reduce costs and enhance quality control.

• Bioequivalence and Reformulation: Some suppliers explore reformulating ALDACTAZIDE in controlled-release formats or combined delivery vehicles, protected by secondary patents or proprietary formulations.

• Supply Chain Resilience: Amid global disruptions, diversification of suppliers, especially sourcing from multiple regions, is vital.

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Conclusion

The supply landscape for ALDACTAZIDE is characterized by a broad spectrum of generic manufacturers, API suppliers, and contract manufacturers. Patent expirations have democratized manufacturing but created a competitive environment where quality, regulatory compliance, and cost-effectiveness define market success. Strategic partnerships, rigorous quality assurance, and compliance with regional regulations remain essential for suppliers targeting this mature yet vital antihypertensive drug.

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Key Takeaways

• Market Expiry of Patents: ALDACTAZIDE's patents expired decades ago, enabling a diverse, price-competitive supplier base.
• Primary Suppliers: Major global generic firms and Indian manufacturers dominate supply, complemented by Chinese API producers.
• Regulatory Compliance: Suppliers must adhere to regional GMP standards to ensure market access, especially in North America and Europe.
• Supply Chain Risks: Diversification and strategic sourcing are necessary to mitigate disruptions and ensure ongoing supply.
• Emerging Opportunities: Reformulation, proprietary delivery methods, and vertical integration present avenues for differentiation and market expansion.

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FAQs

1. Who are the leading suppliers of ALDACTAZIDE globally?
Leading global suppliers include Sandoz (Novartis), Mylan (Viatris), Teva Pharmaceuticals, and Indian manufacturers like Sun Pharmaceutical Industries and Lupin.

2. Are there patent restrictions currently impacting ALDACTAZIDE supply?
No, the primary patents for ALDACTAZIDE and its components have expired, although secondary patents related to specific formulations may still exist in certain regions.

3. What qualities should companies prioritize when sourcing ALDACTAZIDE?
Regulatory compliance, API purity, manufacturing capacity, quality control standards, and supply chain resilience are imperative.

4. How does regional regulation influence supplier choice?
Strict regions like the U.S. and EU require FDA or EMA-approved manufacturing facilities, affecting sourcing decisions and supplier qualification processes.

5. What market opportunities exist beyond traditional manufacturing?
Reformulating ALDACTAZIDE for extended release, proprietary delivery systems, and integrating supply chains vertically are promising avenues.

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References

1. [1] U.S. Food and Drug Administration. "Drug Approvals and Safety Notifications."
2. [2] European Medicines Agency. "Guidelines on Good Manufacturing Practices."
3. [3] IMS Health Data. "Global Generic Drugs Market Analysis."
4. [4] Indian Pharmaceutical Association. "API Manufacturing Capacity Report."
5. [5] Chinese Pharmaceutical Industry Data. "APIs and Finished Dosage Forms."