DOXAZOSIN MESYLATE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269	NDA	Viatris Specialty LLC	58151-078-93	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-078-93)	2024-04-23
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269	NDA	Viatris Specialty LLC	58151-079-93	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)	2024-01-04
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668	NDA	ROERIG	0049-2410-10	100 TABLET in 1 BOTTLE (0049-2410-10)	2021-10-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies and analyzes key suppliers of doxazosin mesylate, a widely prescribed alpha-blocker used to treat hypertension and benign prostatic hyperplasia (BPH). The analysis focuses on manufacturing capabilities, regulatory compliance, and market presence to inform strategic sourcing and investment decisions.

What is Doxazosin Mesylate and What Are Its Primary Applications?

Doxazosin mesylate is an alpha-1 adrenergic receptor antagonist. It functions by relaxing blood vessels, which lowers blood pressure, and by relaxing muscles in the prostate and bladder neck, improving urine flow. The drug is available in both immediate-release and extended-release formulations.

Primary applications include:

Hypertension: Treatment of high blood pressure.
Benign Prostatic Hyperplasia (BPH): Alleviation of urinary symptoms associated with an enlarged prostate.

Who Are the Leading Manufacturers and Suppliers of Doxazosin Mesylate?

The global supply chain for doxazosin mesylate involves several key manufacturers and suppliers, primarily located in India and China, alongside established players in Europe and North America. These entities range from large multinational pharmaceutical corporations to specialized contract manufacturing organizations (CMOs) and active pharmaceutical ingredient (API) producers.

Major API Manufacturers

Company Name	Country of Origin	Key Products/Services	Notes
Aurobindo Pharma	India	Doxazosin Mesylate API, Finished Dosage Forms	Significant global presence, strong regulatory track record.
Dr. Reddy's Laboratories	India	Doxazosin Mesylate API, Branded and Generic Formulations	Established API producer with integrated manufacturing capabilities.
Lupin Limited	India	Doxazosin Mesylate API, Generic Formulations	Focus on APIs and finished generics, broad international market reach.
Sun Pharmaceutical Industries	India	Doxazosin Mesylate API, Diverse Generic Portfolio	One of the largest generic pharmaceutical companies globally.
Torrent Pharmaceuticals	India	Doxazosin Mesylate API, Various therapeutic areas	Vertically integrated operations, strong focus on regulated markets.
Teva Pharmaceutical Industries	Israel	Doxazosin Mesylate API, Extensive Generic Product Line	Major global generic drug manufacturer with significant API production.
Zydus Lifesciences (formerly Cadila Healthcare)	India	Doxazosin Mesylate API, Broad API and Formulation Offerings	Strong R&D capabilities, diversified product portfolio.
IOL Chemicals and Pharmaceuticals Ltd.	India	Doxazosin Mesylate API	Specializes in bulk drug manufacturing, including APIs for cardiovascular and CNS segments.
Divi's Laboratories	India	Doxazosin Mesylate API	Leading custom synthesis and manufacturing company, known for high-volume API production.
Amneal Pharmaceuticals	United States	Doxazosin Mesylate API, Finished Dosage Forms	Growing US-based player with increasing manufacturing capacity.
Piramal Pharma Solutions	India	Contract Development and Manufacturing (CDMO) services for APIs, including Doxazosin Mesylate	Offers custom synthesis and manufacturing for pharmaceutical clients.

Key Finished Dosage Form Manufacturers and Marketers

While API manufacturers form the base of the supply chain, many also produce finished dosage forms (FDFs) or partner with FDF manufacturers. Companies like Pfizer (originator brand, Cardura), Teva, Aurobindo, Dr. Reddy's, and Sun Pharma market doxazosin mesylate formulations globally.

What Are the Regulatory Requirements for Doxazosin Mesylate Production?

Doxazosin mesylate production is subject to stringent regulatory oversight by global health authorities to ensure product quality, safety, and efficacy. Key requirements include adherence to Good Manufacturing Practices (GMP).

Key Regulatory Standards and Bodies

Current Good Manufacturing Practices (cGMP): Mandated by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national regulatory bodies. cGMP covers all aspects of manufacturing, including personnel, facilities, equipment, raw materials, production processes, and quality control.
Drug Master Files (DMFs): Manufacturers of APIs typically file DMFs with regulatory agencies like the FDA. These confidential documents contain detailed information about the manufacturing process, facilities, and controls for an API. Other companies can reference a DMF in their drug product applications.
Inspections: Regulatory bodies conduct routine inspections of manufacturing facilities to ensure compliance with cGMP. For doxazosin mesylate, successful inspections by agencies such as the FDA, EMA, PMDA (Japan), and Health Canada are critical for market access in these regions.
ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides globally recognized guidelines on quality, safety, efficacy, and multidisciplinary topics relevant to drug manufacturing and registration.

Specific Country Regulatory Considerations

United States (FDA): Requires DMF submission and successful facility inspections for APIs. Generic drug applications (ANDAs) must demonstrate bioequivalence to the reference listed drug.
European Union (EMA): Requires Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) or equivalent documentation, alongside GMP compliance.
India (CDSCO): The Central Drugs Standard Control Organisation oversees drug manufacturing and approval. Indian manufacturers supplying globally must also meet the requirements of importing countries.

What is the Market Landscape and Competitive Environment for Doxazosin Mesylate?

The doxazosin mesylate market is largely driven by generic competition following patent expirations. The demand is influenced by the prevalence of hypertension and BPH, particularly in aging populations.

Market Dynamics

Generic Dominance: The market is saturated with generic versions of doxazosin mesylate, leading to significant price competition.
Volume-Driven: Success in this market relies heavily on high-volume production and cost-efficiency.
Geographic Distribution: Demand is highest in developed markets (North America, Europe) and is growing in emerging economies.
Extended-Release Formulations: Extended-release versions offer therapeutic advantages and can command slightly higher prices or market share, but also face generic competition.

Competitive Factors

Cost of Production: Raw material costs, manufacturing efficiency, and labor costs are critical differentiators.
Regulatory Compliance: A strong regulatory history and ability to pass inspections are paramount for market access.
Supply Chain Reliability: Consistent and dependable supply is essential for pharmaceutical formulators.
Product Quality: High-purity API and adherence to pharmacopoeial standards (e.g., USP, EP) are non-negotiable.

What Are the Key Manufacturing and Quality Control Considerations?

Producing high-quality doxazosin mesylate API requires robust manufacturing processes and rigorous quality control measures.

Manufacturing Process Overview

The synthesis of doxazosin mesylate typically involves multiple chemical steps, starting from basic chemical precursors. Key intermediates are then reacted to form the doxazosin base, which is subsequently converted to its mesylate salt. Each step requires precise control of reaction conditions, solvents, and purification methods to achieve the desired purity and yield.

Critical Quality Attributes (CQAs)

Assay: The concentration of doxazosin mesylate in the API, typically specified as 98.0% to 102.0% on a dried basis.
Related Substances/Impurities: Strict limits are placed on known and unknown impurities, degradation products, and residual solvents. These are monitored using techniques like High-Performance Liquid Chromatography (HPLC).
Particle Size Distribution: Important for formulation development, especially for solid oral dosage forms, affecting dissolution rates and bioavailability.
Polymorphism: Doxazosin mesylate can exist in different crystalline forms (polymorphs), which can impact its physical properties, stability, and bioavailability. Manufacturers must control polymorphic form.
Water Content: Controlled to ensure stability and prevent degradation.
Heavy Metals: Limits are enforced to ensure safety.

Quality Control Testing

Identification: Spectroscopic methods (e.g., IR, NMR) and chemical tests confirm the identity of the substance.
Assay and Purity: HPLC is the primary method for quantifying the API and detecting impurities.
Dissolution Testing: For finished dosage forms, this measures the rate at which the drug dissolves.
Stability Studies: Conducted under various temperature and humidity conditions to determine shelf-life and storage requirements.
Microbiological Limits: For APIs intended for sterile formulations, testing for microbial contamination is crucial.

What Are the Future Trends and Potential Challenges?

The doxazosin mesylate market, while mature, continues to evolve with potential shifts in manufacturing, regulatory landscapes, and therapeutic approaches.

Emerging Trends

Increased Focus on Supply Chain Resilience: Geopolitical events and global health crises have highlighted the need for diversified and secure API sourcing. This may lead to a greater emphasis on dual sourcing and near-shoring or re-shoring of manufacturing.
Advanced Manufacturing Technologies: Implementation of continuous manufacturing and process analytical technology (PAT) could improve efficiency, reduce costs, and enhance quality control in API production.
Sustainability: Growing pressure for environmentally friendly manufacturing processes, including solvent recovery and waste reduction.

Potential Challenges

Intensifying Price Pressure: Continued generic competition is likely to drive prices down, challenging manufacturers' margins.
Regulatory Scrutiny: Evolving regulatory requirements and increased inspection frequency by major health authorities could pose compliance challenges for some suppliers.
Raw Material Volatility: Fluctuations in the cost and availability of key starting materials can impact production economics.
Development of New Therapies: The introduction of novel treatments for hypertension and BPH could, over the long term, reduce the demand for established drugs like doxazosin mesylate.

Key Takeaways

Doxazosin mesylate is a well-established generic pharmaceutical with a competitive global supply market dominated by Indian and Chinese API manufacturers.
Regulatory compliance, particularly adherence to cGMP and successful FDA/EMA inspections, is critical for market access in developed regions.
Key suppliers include Aurobindo Pharma, Dr. Reddy's Laboratories, Lupin, Sun Pharma, and Teva, among others.
Manufacturing success hinges on cost-efficiency, consistent quality, and supply chain reliability.
Future market dynamics will be shaped by supply chain resilience initiatives, advanced manufacturing adoption, and sustained price competition.

Frequently Asked Questions

How is doxazosin mesylate typically synthesized?

Doxazosin mesylate is synthesized through a multi-step chemical process involving the reaction of specific precursors to form the doxazosin base, which is then converted to its mesylate salt. The exact pathway and intermediates are proprietary to individual manufacturers.

Which pharmacopoeial standards must doxazosin mesylate API meet?

Doxazosin mesylate API must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), as applicable to the target market.

What is the significance of a Drug Master File (DMF) for doxazosin mesylate suppliers?

A DMF provides regulatory agencies like the FDA with confidential, detailed information about the manufacturing process, facilities, and controls for an API. It allows drug product manufacturers to reference this information in their own regulatory applications without disclosing proprietary details.

How does particle size distribution affect doxazosin mesylate formulations?

Particle size distribution influences critical aspects of drug formulation, including flow properties, compressibility (for tablets), dissolution rate, and ultimately, the bioavailability of the drug product.

What are the primary impurities monitored in doxazosin mesylate API?

Key impurities monitored include process-related impurities, degradation products, and residual solvents. Strict limits are set for these based on toxicological data and regulatory guidelines to ensure patient safety.

How can a company assess the reliability of a doxazosin mesylate supplier?

Assessment involves reviewing the supplier's regulatory history (FDA/EMA inspection outcomes), financial stability, capacity, quality management systems, and conducting audits of their manufacturing facilities. Sample testing of API batches is also crucial.

What are the implications of patent expiration for doxazosin mesylate?

Patent expiration allows for the introduction of generic versions of doxazosin mesylate, leading to increased competition, price reductions, and a shift in market dynamics towards volume-based production.

How does the extended-release formulation of doxazosin differ in manufacturing and regulation?

Extended-release formulations require specialized manufacturing techniques to control drug release over time. Regulatory review focuses on demonstrating bioequivalence and the consistency of the release profile, which can involve more complex dissolution testing and stability studies.

What is the typical shelf life for doxazosin mesylate API?

The shelf life for doxazosin mesylate API is determined through comprehensive stability studies and is typically between two to five years when stored under specified conditions.

Are there any significant geographical concentrations of doxazosin mesylate API manufacturing?

Yes, a significant concentration of doxazosin mesylate API manufacturing is located in India and China, due to cost advantages and established chemical manufacturing infrastructure.

Sources

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP). Retrieved from [FDA Website] [2] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from [EMA Website] [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH Website] [4] Company websites and publicly available investor relations information for Aurobindo Pharma, Dr. Reddy's Laboratories, Lupin Limited, Sun Pharmaceutical Industries, Torrent Pharmaceuticals, Teva Pharmaceutical Industries, Zydus Lifesciences, IOL Chemicals and Pharmaceuticals Ltd., Divi's Laboratories, Amneal Pharmaceuticals, and Piramal Pharma Solutions. [5] Pharmacopoeial standards (USP, EP, JP) for Doxazosin Mesylate.

Suppliers and packagers for generic pharmaceutical drug: DOXAZOSIN MESYLATE