Suppliers and packagers for generic pharmaceutical drug: METOLAZONE

METOLAZONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-532-31	100 TABLET in 1 BOTTLE (46708-532-31)	2020-12-02
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-532-91	1000 TABLET in 1 BOTTLE (46708-532-91)	2020-12-02
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-533-31	100 TABLET in 1 BOTTLE (46708-533-31)	2020-12-02
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-533-91	1000 TABLET in 1 BOTTLE (46708-533-91)	2020-12-02
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Alembic Pharmaceuticals Limited	46708-534-31	100 TABLET in 1 BOTTLE (46708-534-31)	2020-12-02

Metolazone Drug Component Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supplier landscape for metolazone, a diuretic medication. Key active pharmaceutical ingredient (API) manufacturers and significant intermediate suppliers have been identified. Market dynamics suggest a consolidated API supply chain with a few dominant manufacturers. Availability of raw materials for metolazone synthesis is a critical factor influencing production capacity and pricing.

What are the primary suppliers of metolazone API?

The global supply of metolazone API is concentrated among a limited number of manufacturers. These companies possess the specialized facilities and regulatory compliance necessary for pharmaceutical-grade API production.

• API Manufacturers:
  • Amneal Pharmaceuticals: A significant player in the generic pharmaceutical market, Amneal manufactures metolazone API. The company operates multiple FDA-inspected facilities in the United States, ensuring compliance with stringent quality standards. [1]
  • Teva Pharmaceuticals: Teva is one of the largest generic drug manufacturers globally. Their production capabilities include metolazone API, serving both their internal finished dosage form manufacturing and the external API market. Teva's global manufacturing footprint includes facilities in North America and Europe. [2]
  • Zydus Lifesciences (formerly Cadila Healthcare): This Indian multinational pharmaceutical company is a producer of various APIs, including metolazone. Zydus operates large-scale manufacturing plants in India, adhering to international regulatory requirements such as US FDA and EMA. [3]
  • Sun Pharmaceutical Industries: Another major Indian pharmaceutical company, Sun Pharma, also supplies metolazone API. Sun Pharma's extensive API manufacturing infrastructure supports its broad product portfolio. [4]

These API manufacturers are subject to regular inspections by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Audits focus on Good Manufacturing Practices (GMP), quality control, and assurance systems to ensure product safety and efficacy.

Which companies supply key intermediates for metolazone synthesis?

The synthesis of metolazone involves several chemical intermediates. The supply chain for these intermediates is crucial for uninterrupted API production. While specific, publicly disclosed intermediate suppliers can be proprietary, the general chemical manufacturing sectors that produce these materials are identifiable.

Metolazone's chemical structure, 7-chloro-2,3,4,5-tetrahydro-3-(2-methylpropyl)-2-oxo-1H-1,2,4-benzothiadiazine-1,1-dioxide, indicates a multi-step synthesis. Key precursor chemicals likely include substituted anilines, isobutylene derivatives, and sulfonyl chlorides.

• General Intermediate Categories and Potential Suppliers:
  • Substituted Anilines: Compounds like 4-amino-2-chlorobenzenesulfonamide are foundational. Manufacturers in the fine chemicals sector, particularly those specializing in aromatic amines and sulfonamides, are primary sources. Companies in China and India, known for their chemical synthesis capabilities, are significant global suppliers in this segment.
  • Alkylating Agents (e.g., Isobutylene derivatives): Reagents to introduce the isobutyl group. Petrochemical companies and specialized organic synthesis firms provide these types of compounds.
  • Chlorinating Agents and Oxidizing Agents: Used in various stages of the synthesis. Industrial chemical producers supply these bulk and specialty chemicals.

The availability and pricing of these intermediates can be influenced by broader chemical market trends, raw material costs (e.g., crude oil derivatives), and geopolitical factors impacting global trade. Supply disruptions in these upstream segments can directly affect metolazone API production timelines and costs.

What is the regulatory landscape for metolazone API suppliers?

Metolazone API suppliers must adhere to strict regulatory frameworks to ensure product quality and patient safety. Compliance is a prerequisite for market access in major pharmaceutical markets.

• Key Regulatory Bodies and Requirements:
  • U.S. Food and Drug Administration (FDA): Requires all API manufacturers supplying the U.S. market to register their facilities and comply with current Good Manufacturing Practices (cGMP). The FDA conducts pre-approval inspections and routine surveillance audits. [5]
  • European Medicines Agency (EMA) and National Competent Authorities (NCAs) in EU Member States: Mandate compliance with EU GMP guidelines. Certificates of Suitability to the European Pharmacopoeia (CEP) are often required for APIs used in medicines marketed in Europe, demonstrating compliance with European Pharmacopoeia monographs. [6]
  • Other National Regulatory Agencies: Agencies in Japan (PMDA), Canada (Health Canada), Australia (TGA), and other countries have their own specific requirements, often aligned with international standards.
  • Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory authorities. These confidential documents contain detailed information about the API manufacturing process, facilities, quality controls, and stability data. While not publicly disclosed, they are reviewed by regulatory agencies during the approval process of finished drug products.

Suppliers must maintain robust quality management systems, including process validation, change control, deviation management, and rigorous testing of raw materials, intermediates, and the final API. Any significant change in the manufacturing process, raw material source, or facility requires notification and potential re-validation, impacting the supply chain's agility.

How is the metolazone API market structured?

The metolazone API market is characterized by a balance of established generic manufacturers and the potential for new entrants if market conditions are favorable. The market size is primarily driven by the demand for generic metolazone finished dosage forms.

• Market Dynamics:
  • Generic Competition: Metolazone is available as a generic medication, leading to price sensitivity in the API market. API suppliers compete on cost, quality, reliability, and regulatory compliance.
  • Consolidation: The pharmaceutical industry has seen consolidation among both finished dosage form manufacturers and API suppliers. This can lead to fewer, larger players dominating specific API markets.
  • Geographic Concentration: A significant portion of global API manufacturing, including intermediates and finished APIs, is concentrated in India and China due to cost advantages and established chemical manufacturing infrastructure. However, North American and European manufacturers also play a role, particularly for specialized or high-quality APIs.
  • Contract Manufacturing Organizations (CMOs): While the primary API suppliers listed are integrated manufacturers, CMOs can also play a role in metolazone API synthesis, offering specialized chemical synthesis services.

The demand for metolazone is relatively stable, primarily linked to its therapeutic use in treating hypertension and edema. Market growth is generally tied to overall growth in the cardiovascular drug segment and generic drug market penetration.

What are the supply chain risks for metolazone?

Supply chain risks for metolazone API can impact pricing, availability, and lead times. These risks are multifaceted, ranging from regulatory challenges to geopolitical instability.

• Key Supply Chain Risks:
  • Raw Material Shortages or Price Volatility: Dependence on a limited number of suppliers for critical chemical intermediates or raw materials can lead to shortages or significant price fluctuations, directly impacting API production costs and schedules.
  • Geopolitical Instability and Trade Restrictions: Political events, trade wars, or tariffs in key manufacturing regions (e.g., China, India) can disrupt the flow of APIs and intermediates.
  • Regulatory Non-Compliance and Plant Shutdowns: Failure to meet cGMP standards or unexpected plant shutdowns due to accidents, environmental issues, or quality failures by an API manufacturer can immediately reduce global supply.
  • Quality Control Issues and Recalls: API quality issues can lead to batch rejections, recalls of finished products, and significant reputational damage, impacting a supplier's market standing and potentially leading to regulatory sanctions.
  • Logistical Challenges: Shipping disruptions, port congestion, or increased freight costs can delay deliveries of APIs and intermediates, affecting inventory management and production planning.
  • Intellectual Property and Patent Landscape: While metolazone is an older drug with expired primary patents, any new process patents or formulation patents could introduce complexities for generic manufacturers and their API suppliers.

Mitigation strategies for these risks include diversifying supplier bases for critical raw materials and intermediates, maintaining strategic inventory levels, conducting thorough supplier audits, and staying abreast of geopolitical and regulatory developments.

Key Takeaways

• The global supply of metolazone API is concentrated among a few key manufacturers, including Amneal Pharmaceuticals, Teva Pharmaceuticals, Zydus Lifesciences, and Sun Pharmaceutical Industries.
• The synthesis of metolazone relies on a supply chain of various chemical intermediates, with significant manufacturing capabilities located in China and India for these precursors.
• All metolazone API suppliers must comply with stringent regulatory requirements from bodies such as the FDA and EMA, including adherence to cGMP standards.
• The metolazone API market is characterized by generic competition, a degree of market consolidation, and a reliance on established manufacturing hubs in Asia.
• Supply chain risks include raw material availability, geopolitical factors, regulatory compliance failures, quality control issues, and logistical challenges.

Frequently Asked Questions

1. Are there any novel or emerging suppliers of metolazone API? Currently, the metolazone API market appears dominated by established generic manufacturers. Significant emerging suppliers are not publicly evident, indicating a mature market segment.

2. What are the typical lead times for ordering metolazone API from manufacturers? Lead times can vary based on manufacturer capacity, existing order volumes, and raw material availability, but typically range from 8 to 16 weeks.

3. What is the impact of excipient suppliers on the metolazone finished dosage form? While this analysis focuses on API suppliers, excipient suppliers are critical for finished dosage forms. Their reliability and quality are essential for tablet formulation, dissolution profiles, and overall drug product stability.

4. How do regulatory changes, such as new impurity guidelines, affect metolazone API suppliers? Suppliers must adapt to evolving regulatory standards for impurities (e.g., nitrosamines). This may require process modifications, re-validation, and enhanced analytical testing, potentially increasing production costs and timelines.

5. What is the typical minimum order quantity (MOQ) for metolazone API? MOQs for metolazone API can range from tens of kilograms to several hundred kilograms, depending on the manufacturer and their production batch sizes.

Citations

[1] Amneal Pharmaceuticals. (n.d.). API Manufacturing. Retrieved from https://www.amneal.com/api-manufacturing/ [2] Teva Pharmaceuticals. (n.d.). Our Products & Services. Retrieved from https://www.tevapharm.com/our-business/ [3] Zydus Lifesciences. (n.d.). API Business. Retrieved from https://www.zyduslife.com/business-segments/api/ [4] Sun Pharmaceutical Industries Ltd. (n.d.). API. Retrieved from https://www.sunpharma.com/business/api [5] U.S. Food and Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) for Drugs. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-and-manufacturing/current-good-manufacturing-practice-cgmp-drugs [6] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/quality-regulation/good-manufacturing-practice-gmp