Suppliers and packagers for 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

Suppliers for the Pharmaceutical Drug: METOLAZONE

Last updated: July 27, 2025

Introduction

Metolazone is a potent thiazide-like diuretic primarily prescribed for managing hypertension and edema associated with congestive heart failure or renal disease. As a critical component in cardiovascular therapy, ensuring a reliable supply chain for Metolazone is vital for healthcare providers, pharmaceutical manufacturers, and patients. This comprehensive analysis examines the key suppliers involved in manufacturing and distributing Metolazone, their production capacities, regulatory landscapes, and strategic implications for stakeholders.

Overview of Metolazone Production and Market Dynamics

Metolazone’s synthetic complexity and manufacturing processes influence its supply chain robustness. The global market for diuretics is competitive, with multiple pharmaceutical companies engaged in producing both branded and generic formulations. The primary regions producing Metolazone include North America, Europe, and parts of Asia, where research, manufacturing expertise, and regulatory approvals converge.

According to recent industry reports, the global demand for Metolazone remains steady, driven by the ongoing prevalence of hypertension and renal conditions [1]. Despite its widespread use, procurement challenges, supply shortages, and regulatory hurdles can impact raw material sourcing, manufacturing, and distribution.

Key Suppliers and Manufacturers

1. Major Pharmaceutical Companies

Several pharmaceutical companies dominate the manufacturing landscape of Metolazone, often through generic drug producers, which have expanded rapidly following patent expirations.

• Teva Pharmaceutical Industries Ltd.
  As a leading global generic drug manufacturer, Teva supplies Metolazone under various brand names and as a generic product. Their extensive manufacturing base in Israel and the United States makes them a key player with significant capacity to meet global demand [2].

• Mitsubishi Tanabe Pharma Corporation
  This Japanese pharmaceutical company has historically produced Metolazone for the Asian markets, leveraging its robust R&D and manufacturing infrastructure. Their products often adhere to high regulatory standards in Japan and neighboring countries [3].

• Sandoz (Novartis)
  As a division of Novartis, Sandoz produces generic medications including Metolazone, distributing across Europe and North America. Their global distribution network enhances supply stability for this diuretic [4].

• Aurobindo Pharma
  An established Indian manufacturer, Aurobindo has increased its capacity for producing diuretics, including Metolazone, catering to both local and export markets. Their cost-effective manufacturing has made them a significant supplier, especially in emerging markets [5].

2. Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

The manufacturing of Metolazone hinges on the availability of high-purity APIs. The primary raw materials are synthesized through advanced chemical processes involving chlorination and benzene derivatives.

• Chinese API Manufacturers
  China remains a dominant supplier of raw chemicals used in APIs globally. Companies like Zhejiang Huahai Pharmaceutical and Shanghai ChemPartner produce intermediates vital to Metolazone synthesis. Their large-scale operations and cost advantages underpin global supply chains [6].

• Indian API Producers
  Firms such as Hikal Ltd. and Natco Pharma manufacture key intermediates and APIs, offering quality and reliable delivery to global markets [7].

3. Contract Manufacturing Organizations (CMOs)

Numerous CMOs undertake formulation and finishing processes for generic Metolazone, offering flexibility and capacity expansion.

• Generics-focused CMOs
  Companies like ACG Worldwide (India) and Alchemie (India) specialize in sterile and solid-dose formulations, providing essential manufacturing support as demand fluctuates [8].

Regulatory Considerations and Market Access

Suppliers for Metolazone must navigate diverse regulatory environments. The US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national agencies impose rigorous standards on APIs and finished formulations. This complexity affects supplier certification, quality assurance, and ongoing compliance.

Manufacturers often seek regulatory approvals in multiple jurisdictions to access global markets. As a result, suppliers investing in good manufacturing practice (GMP) certifications and certifications like ISO 9001 are favored partners.

Supply Chain Challenges and Strategic Implications

• Raw Material Constraints
  Disruptions in Chinese or Indian API production due to COVID-19, geopolitical issues, or regulatory crackdowns can lead to shortages [9].

• Quality Assurance
  Ensuring consistent API quality is crucial. Suppliers with proven compliance histories and rigorous quality control processes are preferred for risk mitigation.

• Price Fluctuations
  Cost pressures from raw materials and manufacturing capacities influence the pricing of Metolazone and determine supplier competitiveness.

• Geopolitical Risks
  Trade tensions, export restrictions, and tariffs can limit supply availability in certain regions, prompting diversification strategies among purchasers.

Conclusion

The supply of Metolazone hinges on a diverse network of global manufacturers and raw material suppliers. Major pharmaceutical companies such as Teva, Sandoz, and Mitsubishi Tanabe Pharma play pivotal roles in the final formulation supply chain, while Chinese and Indian API producers form the backbone of raw material sourcing. Navigating regulatory frameworks, ensuring quality, and managing geopolitical risks remain essential for maintaining supply stability.

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Key Takeaways

• Diverse Supply Network: The global landscape of Metolazone involves prominent pharmaceutical manufacturers and a robust API supply chain primarily from China and India.
• Regulatory Vigilance: Suppliers adhering to strict GMP and regulatory standards are preferable, ensuring product quality and market access.
• Supply Chain Risks: Raw material shortages, geopolitical tensions, and quality issues can disrupt supplies; sourcing diversification mitigates these risks.
• Market Dynamics: The generic market's competitiveness influences pricing, supply availability, and strategic supplier relationships.
• Strategic Partnership: Long-term relationships with regulated, quality-focused suppliers support consistent supply and regulatory compliance.

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FAQs

1. Who are the leading global suppliers of Metolazone?
Major suppliers include Teva Pharmaceutical Industries, Sandoz (Novartis), Mitsubishi Tanabe Pharma, and Aurobindo Pharma, with raw materials sourced predominantly from Chinese and Indian API manufacturers.

2. How does regulatory compliance impact Metolazone supply?
Regulatory standards ensure product quality and safety, affecting manufacturing licenses, export eligibility, and market access. Non-compliance can lead to supply disruptions and market restrictions.

3. What are the common raw materials used in Metolazone synthesis?
Key intermediates involve chlorinated benzene derivatives, which are sourced mainly from Chinese and Indian API producers, adhering to high purity standards.

4. What challenges threaten the stability of Metolazone supplies?
Supply disruptions can stem from raw material shortages, regulatory changes, geopolitical tensions, and manufacturing capacity limitations.

5. How can stakeholders mitigate supply chain risks for Metolazone?
Diversification of suppliers across regions, maintaining quality certifications, monitoring geopolitical developments, and building strategic inventory buffers are effective strategies.

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Sources

1. GlobalData. Pharmaceutical Market Outlook. 2023.
2. Teva Pharmaceuticals Annual Report. 2022.
3. Mitsubishi Tanabe Pharma. Corporate Overview. 2022.
4. Novartis Sandoz Division. Product Portfolio. 2022.
5. Aurobindo Pharma Annual Report. 2022.
6. Chinese API Producer Profiles. Chemical Weekly. 2022.
7. Indian API Manufacturing Sector Report. Pharmaceutical Commerce. 2022.
8. Contract Manufacturing Industry Insights. CPhI Reports. 2022.
9. WHO Report on API Supply Chain Risks. 2022.

Note: The data and insights presented in this article are based on publicly available industry reports, regulatory filings, and market analyses as of early 2023.