Suppliers and packagers for generic pharmaceutical drug: CHLOROTHIAZIDE SODIUM

CHLOROTHIAZIDE SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202561	ANDA	American Regent, Inc.	0517-1820-01	1 VIAL in 1 CARTON (0517-1820-01) / 18 mL in 1 VIAL	2015-04-01
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896	ANDA	Fresenius Kabi USA, LLC	63323-658-27	1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL	2009-10-21
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896	ANDA	Fresenius Kabi USA, LLC	63323-658-20	1 VIAL in 1 BOX (63323-658-20) / 18 mL in 1 VIAL	2009-10-21
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896	ANDA	Fresenius Kabi USA, LLC	63323-658-94	1 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL	2009-10-21
Gland	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	218630	ANDA	Gland Pharma Limited	68083-614-01	1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL	2024-10-03

Chlorothiazide Sodium Suppliers: Global Market Overview and Key Players

Last updated: February 19, 2026

Chlorothiazide sodium, a thiazide diuretic used to treat hypertension and edema, relies on a global network of chemical suppliers for its active pharmaceutical ingredient (API) and key intermediates. The market for these suppliers is characterized by stringent regulatory requirements, quality control protocols, and evolving manufacturing capacities. Key players operate in established pharmaceutical manufacturing hubs, with a significant presence in Asia.

What is the Market Landscape for Chlorothiazide Sodium Suppliers?

The market for chlorothiazide sodium suppliers is segmented by API manufacturers and intermediate suppliers. API manufacturers are responsible for synthesizing the final drug substance meeting pharmacopoeial standards, such as those set by the United States Pharmacopeia (USP) or European Pharmacopoeia (EP). Intermediate suppliers provide the chemical building blocks necessary for API synthesis.

The global demand for chlorothiazide sodium is influenced by the prevalence of cardiovascular diseases and the associated treatment guidelines. While it is a mature drug, consistent demand from both developed and emerging markets sustains the need for reliable suppliers.

Key market drivers include:

• Aging Population: Increasing global life expectancy contributes to a higher incidence of conditions treated by chlorothiazide sodium.
• Hypertension Prevalence: The sustained global rise in hypertension rates directly impacts the demand for antihypertensive medications.
• Generic Drug Market Growth: The continued expansion of the generic drug market necessitates cost-effective and high-quality API sourcing.

Challenges facing the supplier market include:

• Regulatory Scrutiny: Pharmaceutical ingredient manufacturing is subject to rigorous inspection and compliance with Good Manufacturing Practices (GMP).
• Supply Chain Volatility: Geopolitical events, raw material shortages, and logistics disruptions can impact availability and pricing.
• Price Pressure: Competition among generic drug manufacturers often translates into downward price pressure on APIs and intermediates.

The primary manufacturing regions for chlorothiazide sodium API and its key intermediates are China and India, known for their established chemical synthesis capabilities and competitive pricing. Europe and North America also host some specialized manufacturers, often focusing on niche markets or higher-purity grades.

Who are the Leading API Manufacturers for Chlorothiazide Sodium?

Leading manufacturers of chlorothiazide sodium API primarily operate in India and China, leveraging economies of scale and specialized chemical synthesis expertise. These companies are typically certified by regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to supply the drug substance for pharmaceutical formulations.

Prominent API manufacturers identified in the market include:

• Lupin Ltd. (India): A global pharmaceutical company with significant API manufacturing capabilities. Lupin has a broad portfolio of generics and active ingredients.
• Aurobindo Pharma Ltd. (India): A major Indian pharmaceutical company with a strong focus on R&D and manufacturing of APIs and finished dosage forms.
• Sun Pharmaceutical Industries Ltd. (India): One of the largest pharmaceutical companies globally, with extensive API manufacturing facilities and a diversified product range.
• Dr. Reddy's Laboratories Ltd. (India): A multinational pharmaceutical company engaged in the development, manufacturing, and marketing of a wide range of pharmaceutical products, including APIs.
• Zydus Lifesciences Ltd. (formerly Cadila Healthcare Ltd.) (India): An integrated global pharmaceutical company with a strong API manufacturing base.
• Shijiazhuang Pharma Group (China): A significant player in the Chinese pharmaceutical industry, with capabilities in API synthesis for various therapeutic areas.
• Jiangsu Hengrui Medicine Co., Ltd. (China): A prominent Chinese pharmaceutical company with a growing API manufacturing division.

These companies typically adhere to strict quality control measures and possess DMF (Drug Master File) submissions with regulatory authorities, facilitating their products' use in pharmaceutical applications worldwide.

Which Companies Supply Key Intermediates for Chlorothiazide Sodium Synthesis?

The synthesis of chlorothiazide sodium involves several chemical intermediates. Companies specializing in fine chemicals and custom synthesis are key suppliers of these materials. The availability and purity of these intermediates directly impact the efficiency and quality of the final API production.

Key intermediates in chlorothiazide sodium synthesis often include:

• 5-Chloro-2,4-disulfamoylaniline: A crucial precursor.
• Formaldehyde: Used in certain synthetic routes.
• Sodium Hydroxide: For salt formation.

Companies supplying these types of intermediates operate globally, with significant manufacturing bases in Asia, Europe, and North America.

Key intermediate suppliers include:

• BASF SE (Germany): A leading global chemical company with a broad range of chemical products, including intermediates for pharmaceuticals.
• Merck KGaA (Germany): While known for its pharmaceutical products, Merck KGaA also has a significant chemicals division supplying various raw materials and intermediates.
• Evonik Industries AG (Germany): A specialty chemicals company that provides a wide array of products, including those for the pharmaceutical sector.
• Sachem Inc. (USA): A specialty chemical manufacturer known for its high-purity reagents and catalysts.
• Hubei Jusheng Technology Co., Ltd. (China): A Chinese chemical company engaged in the production and export of pharmaceutical intermediates.
• Shanghai Aladdin Biochemical Technology Co., Ltd. (China): A supplier of research chemicals and pharmaceutical intermediates in China.

The selection of intermediate suppliers is critical for API manufacturers, requiring thorough due diligence regarding product quality, consistency, regulatory compliance, and supply chain reliability.

What are the Regulatory Considerations for Chlorothiazide Sodium Suppliers?

Suppliers of chlorothiazide sodium API and its intermediates must navigate a complex web of international and national regulations to ensure product safety, efficacy, and quality. Compliance is paramount for market access and sustained business operations.

Key regulatory considerations include:

• Good Manufacturing Practices (GMP): Adherence to GMP guidelines, as defined by bodies like the FDA (21 CFR Part 210/211) and EMA (EudraLex Volume 4), is mandatory for API manufacturing. This covers all aspects of production, from facility design and personnel training to quality control and record-keeping.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF contains detailed information about the manufacturing process, facilities, and quality control of the API. It allows regulatory agencies to review this confidential information without disclosing it to the drug product applicant.
• Pharmacopoeial Compliance: APIs must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). This includes standards for identity, purity, assay, and impurity profiles.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines on various aspects of pharmaceutical development and manufacturing, including impurity testing (ICH Q3A/B/C) and quality risk management (ICH Q9).
• Site Inspections and Audits: Regulatory agencies conduct periodic inspections of manufacturing facilities to ensure ongoing compliance with GMP. Pharmaceutical companies also conduct their own audits of suppliers to verify quality systems.
• Environmental, Health, and Safety (EHS) Regulations: Suppliers must comply with local and international EHS regulations related to chemical handling, waste disposal, and worker safety.

Suppliers who can demonstrate robust quality management systems and a history of successful regulatory inspections are preferred partners for pharmaceutical companies.

How is the Quality of Chlorothiazide Sodium Assessed?

The quality of chlorothiazide sodium is rigorously assessed through a battery of analytical tests to ensure it meets predefined purity, potency, and safety standards. These tests are typically performed by both the manufacturer and the pharmaceutical company purchasing the API.

Standard quality assessment methods include:

• Identification Tests: Techniques like Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC) are used to confirm the identity of the chlorothiazide sodium.
• Assay: HPLC is commonly used to determine the precise quantity of chlorothiazide sodium present in the sample, ensuring it falls within the specified range (e.g., 98.0% to 102.0% on an anhydrous basis).
• Impurity Profiling: HPLC, Gas Chromatography (GC), and Mass Spectrometry (MS) are employed to identify and quantify related substances, residual solvents, and degradation products. Limits for specific impurities are defined by pharmacopoeias and ICH guidelines.
• Water Content: The Karl Fischer titration method is used to determine the moisture content, which is crucial for stability and formulation.
• Heavy Metals: Tests are conducted to ensure that levels of heavy metals (e.g., lead, mercury, arsenic) are below acceptable limits.
• Appearance: Visual inspection for color and physical form (e.g., white to off-white crystalline powder).
• pH: Measurement of the pH of a solution of the drug substance.
• Microbial Limits: Testing for the presence of objectionable microorganisms.

Each batch of chlorothiazide sodium API released for sale must be accompanied by a Certificate of Analysis (CoA) detailing the results of these tests and confirming compliance with the approved specifications.

What are the Key Trends in the Chlorothiazide Sodium Supplier Market?

The market for chlorothiazide sodium suppliers is influenced by several evolving trends, primarily driven by advancements in pharmaceutical manufacturing, regulatory landscapes, and global economic factors.

Key trends include:

• Increased Focus on Supply Chain Resilience: Following global disruptions, pharmaceutical companies are placing greater emphasis on diversifying their supplier base and ensuring robust supply chains for APIs and intermediates. This includes seeking suppliers with multiple manufacturing sites or strong business continuity plans.
• Technological Advancements in Synthesis: Manufacturers are exploring and implementing more efficient and environmentally friendly synthetic routes for chlorothiazide sodium and its intermediates. This can involve the adoption of continuous manufacturing processes, biocatalysis, or novel catalyst technologies to reduce waste and improve yields.
• Enhanced Quality Control and Data Integrity: Regulatory agencies are increasingly scrutinizing data integrity in pharmaceutical manufacturing. Suppliers are investing in advanced analytical technologies and robust electronic record-keeping systems to ensure the accuracy and reliability of quality data.
• Geographic Diversification of Manufacturing: While Asia remains a dominant manufacturing hub, some companies are exploring or expanding manufacturing capabilities in other regions to mitigate geopolitical risks and comply with local sourcing requirements.
• Sustainability Initiatives: Growing pressure from regulators, investors, and the public is driving suppliers to adopt more sustainable manufacturing practices, including reducing energy consumption, minimizing hazardous waste, and improving water usage efficiency.

These trends collectively shape the competitive landscape, pushing suppliers to innovate, enhance their quality systems, and build more resilient operations.

Key Takeaways

• The chlorothiazide sodium supply chain involves API manufacturers and intermediate suppliers, with significant presence in India and China.
• Leading API manufacturers include Lupin, Aurobindo Pharma, Sun Pharma, Dr. Reddy's Laboratories, Zydus Lifesciences, Shijiazhuang Pharma Group, and Jiangsu Hengrui Medicine.
• Key intermediates are supplied by global chemical companies such as BASF, Merck KGaA, Evonik, Sachem, Hubei Jusheng Technology, and Shanghai Aladdin Biochemical Technology.
• Regulatory compliance, particularly GMP, DMF submissions, and pharmacopoeial standards, is critical for all suppliers.
• Quality assessment involves rigorous analytical testing including identity, assay, impurity profiling, and physical characteristics.
• Market trends emphasize supply chain resilience, technological advancements, enhanced data integrity, geographic diversification, and sustainability.

Frequently Asked Questions

1. What are the primary regulatory hurdles for a new supplier entering the chlorothiazide sodium market?

New suppliers face significant hurdles including establishing GMP-compliant manufacturing facilities, developing and validating analytical methods for quality control, preparing comprehensive Drug Master Files (DMFs) for submission to regulatory agencies like the FDA and EMA, and successfully passing rigorous site inspections by these authorities.

2. How does the purity of key intermediates affect the final chlorothiazide sodium API quality?

The purity of key intermediates is directly correlated with the quality and impurity profile of the final chlorothiazide sodium API. Impurities present in intermediates can carry through the synthesis process or react to form new, undesirable impurities in the API, potentially impacting its efficacy, safety, and compliance with pharmacopoeial standards.

3. What is the typical shelf life of chlorothiazide sodium API, and how is it determined?

The typical shelf life of chlorothiazide sodium API is often between 2 to 5 years when stored under recommended conditions. This is determined through comprehensive stability studies conducted in accordance with ICH guidelines (e.g., ICH Q1A(R2)). These studies involve storing the API under various temperature and humidity conditions and periodically testing it for physical, chemical, and microbiological degradation.

4. How do geopolitical factors impact the supply and pricing of chlorothiazide sodium?

Geopolitical factors, such as trade disputes, political instability in manufacturing regions, or imposition of tariffs, can disrupt supply chains, increase raw material costs, and lead to price volatility for chlorothiazide sodium. For instance, trade restrictions between major manufacturing and consuming nations can limit product flow and create supply shortages, driving up prices.

5. What are the implications of counterfeit or substandard chlorothiazide sodium API entering the market?

The implications of counterfeit or substandard chlorothiazide sodium API entering the market are severe. They include risks to patient safety due to ineffective treatment or the presence of harmful impurities, potential for severe adverse drug reactions, erosion of public trust in pharmaceutical products and regulatory systems, and significant financial losses for legitimate manufacturers and healthcare providers.

Citations

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 & 211 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General. Retrieved from [FDA Website] (Specific URL not provided due to dynamic nature of FDA site, but navigable via CFR search). [2] European Medicines Agency. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union, Volume 4 - Good Manufacturing Practice. Retrieved from [EMA Website] (Specific URL not provided due to dynamic nature of EMA site, but navigable via EudraLex search). [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Harmonised Tripartite Guidelines. Retrieved from [ICH Website] (Specific URL not provided due to dynamic nature of ICH site, but navigable via ICH Publications search). [4] United States Pharmacopeia. (n.d.). Pharmacopeial Forum Online. Retrieved from [USP Website] (Access to specific monographs requires subscription or purchase). [5] European Pharmacopoeia. (n.d.). EDQM - European Directorate for the Quality of Medicines & HealthCare. Retrieved from [EDQM Website] (Access to specific monographs requires subscription or purchase).