Suppliers and packagers for generic pharmaceutical drug: INDAPAMIDE

INDAPAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Elizabeth	INDAPAMIDE	indapamide	TABLET;ORAL	074722	ANDA	Actavis Pharma, Inc.	0228-2571-11	100 TABLET, FILM COATED in 1 BOTTLE (0228-2571-11)	2007-01-02
Actavis Elizabeth	INDAPAMIDE	indapamide	TABLET;ORAL	074722	ANDA	Actavis Pharma, Inc.	0228-2571-96	1000 TABLET, FILM COATED in 1 BOTTLE (0228-2571-96)	2007-01-02
Actavis Elizabeth	INDAPAMIDE	indapamide	TABLET;ORAL	074722	ANDA	Actavis Pharma, Inc.	0228-2597-11	100 TABLET, FILM COATED in 1 BOTTLE (0228-2597-11)	2007-01-02

Suppliers for the Pharmaceutical Drug: Indapamide

Last updated: July 27, 2025

Introduction

Indapamide is a widely prescribed diuretic primarily used to treat hypertension and edema associated with congestive heart failure. As a generic medication, its supply chain encompasses multiple manufacturers—ranging from active pharmaceutical ingredient (API) producers to finished drug formulators and distributors. An understanding of key suppliers involved in the production and distribution of Indapamide is vital for pharmaceutical companies, healthcare providers, and investors seeking supply stability, quality assurance, and competitive pricing. This report provides a comprehensive analysis of primary API suppliers, finished product manufacturers, and distribution channels for Indapamide.

Active Pharmaceutical Ingredient (API) Suppliers

Major API Manufacturers

The core of Indapamide production hinges on reliable API suppliers. Several global API manufacturers are recognized for their manufacturing quality, regulatory compliance, and supply capacity.

1. Jinan Haibo Pharmaceutical Co., Ltd. (China)
   Jinan Haibo is among leading Chinese API producers specializing in cardiovascular drug ingredients, including Indapamide. The company emphasizes compliance with Good Manufacturing Practices (GMP) and has received certifications from major regulatory agencies, such as the China Food and Drug Administration (CFDA).

2. Hangzhou Sunflower Pharmaceutical Co., Ltd. (China)
   Recognized for robust API production, Sunflower Pharmaceutical supplies Indapamide to both domestic and international markets, leveraging advanced synthesis processes and quality controls aligned with global standards.

3. Hefei Ruilian Pharmaceutical Co., Ltd. (China)
   Hefei Ruilian offers high-purity Indapamide APIs and has obtained registration approvals from European and Asian regulatory bodies, positioning itself as a key supplier in Asia.

4. Aurobindo Pharma Limited (India)
   Aurobindo is a major global API manufacturer with diverse cardiovascular API portfolio. Their manufacturing facilities in India are GMP-certified, producing high-quality APIs including Indapamide for export markets.

5. Mankato Communications and Chemicals Ltd. (India)
   As a mid-sized API producer, Mankato supplies Indapamide to generic pharmaceutical companies worldwide, emphasizing cost-effective manufacturing processes.

Regulatory Considerations

API suppliers must adhere to international GMP standards and possess certifications like ISO, WHO-GMP, or EMA approvals. For example, Chinese manufacturers such as Jinan Haibo possess multiple certifications, increasingly recognized globally, which facilitates export and regulatory approval in Western markets.

Supply Chain Dynamics

The API market for Indapamide is competitive, with Chinese and Indian manufacturers dominating due to cost advantages and expanding global capacity. However, regulatory scrutiny has increased, especially regarding quality assurance and traceability, influencing buyer supplier choices and encouraging some companies to diversify APIs sources.

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Finished Dosage Form Manufacturers

Global Pharmaceutical Companies Producing Indapamide Tablets

Once APIs are acquired, they are formulated into final dosage forms by pharmaceutical companies. Several manufacturers are notable:

1. Teva Pharmaceutical Industries Ltd.
   As a leader in the generics market, Teva produces and markets Indapamide tablets across numerous countries. Their extensive manufacturing facilities in Israel and India facilitate broad distribution.

2. Sandoz (Novartis Group)
   Sandoz manufactures high-quality generic cardiovascular products, including Indapamide, leveraging its global network of manufacturing sites aligned with stringent regulatory standards.

3. Mylan (Now part of Viatris)
   Mylan has a significant portfolio of generic medicines, with Indapamide being included in several markets due to their efficient supply chain and manufacturing capabilities.

4. Reddy's Laboratories (India)
   Indian generic firm Reddy’s supplies Indapamide tablets regionally and globally, emphasizing affordability and regulatory compliance, particularly in emerging markets.

5. Otsuka Pharmaceutical (Japan)
   While primarily known for proprietary drugs, Otsuka manufactures stock and branded generics, including Indapamide, especially for its domestic Japanese market.

Market Considerations

The presence of multiple manufacturers ensures supply resilience, but competition and regulatory approvals affect pricing and market penetration. The trend toward quality manufacturing and product standardization influences procurement decisions, especially within regions emphasizing regulatory compliance such as the EU and US.

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Distribution and Supply Chain Channels

Bulk Distribution and Wholesalers

Large pharmaceutical distributors, such as McKesson, Cardinal Health, and local regional wholesalers, procure Indapamide in bulk quantities from API producers and finished product manufacturers. These entities serve pharmacies, hospitals, and clinics.

Generic Drug Market and Local Suppliers

In emerging markets such as India, China, and parts of Southeast Asia, local distributors and in-house pharmaceutical manufacturers dominate the supply landscape, often relying on Chinese API producers. Regulatory harmonization efforts and quality assurance initiatives are facilitating more integration into Western supply chains.

Import/Export Dynamics

Global trade policies, tariffs, and quality standards influence supplier choices for pharmaceutical companies. Chinese API exports, for example, are subject to increased scrutiny from regulatory agencies such as the FDA and EMA, impacting supply chain configurations. Certification of API origin and GMP compliance becomes crucial for multinational procurement.

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Key Challenges in Sourcing Indapamide

• Regulatory Compliance: Suppliers must meet strict regulatory standards, including GMP and ISO certifications, to access various markets.

• Quality Assurance: Variability in API quality from emerging manufacturers underscores the importance of rigorous validation and batch testing.

• Supply Stability: Dependence on Chinese and Indian suppliers exposes the market to geopolitical and logistical risks, emphasizing the need for diversification.

• Cost Considerations: Cost effectiveness remains pivotal; Indian and Chinese manufacturers often offer competitive pricing, but compliance considerations may influence supplier selection.

• Traceability and Transparency: Increasing regulatory emphasis on traceability requires comprehensive documentation and certification from suppliers across the supply chain.

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Conclusion

The supply chain for Indapamide encompasses a range of suppliers, from Chinese API manufacturers like Jinan Haibo and Hefei Ruilian to Indian API producers such as Aurobindo Pharma. Finished product manufacturing is dominated by global generic giants including Teva, Sandoz, and Mylan. Ensuring consistent quality, regulatory compliance, and supply stability hinges on strategic supplier diversification and rigorous quality assurance. With rising regulatory scrutiny, transparency, and oversight will become increasingly vital for pharmaceutical companies sourcing Indapamide.

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Key Takeaways

• Diversify API sourcing: Relying solely on Chinese API manufacturers presents geopolitical and regulatory risks; incorporating Indian or other GMP-certified suppliers mitigates supply disruptions.

• Prioritize regulatory compliance: GMP certifications, ISO standards, and traceability are critical when selecting suppliers for quality assurance and market access.

• Monitor geopolitical influences: Trade tensions and export restrictions can impact the availability of APIs, underscoring the need for supply chain resilience.

• Evaluate total cost of procurement: Balance cost considerations with quality standards and regulatory requirements to optimize sourcing strategies.

• Strengthen supply chain transparency: Enhancing documentation and certification processes improves compliance and fosters trust among regulatory agencies.

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FAQs

1. Who are the leading API suppliers for Indapamide?
Chinese companies such as Jinan Haibo Pharmaceutical and Hefei Ruilian are prominent API suppliers, while Indian firms like Aurobindo Pharma also serve as significant sources.

2. What regulatory standards should API suppliers for Indapamide meet?
Suppliers should comply with GMP (Good Manufacturing Practices), ISO certifications, and hold approvals such as WHO-GMP, EMA, or FDA where applicable.

3. Are there regional differences in Indapamide supply chains?
Yes. Chinese API manufacturers mainly serve Asian markets, while Indian and Western manufacturers focus on global regulatory-compliant supplies for Europe, the US, and other regions.

4. How does regulatory scrutiny impact Indapamide supply?
Stringent quality standards and increased inspections compel suppliers to adhere strictly to compliance protocols, potentially affecting lead times and availability.

5. What strategies can companies adopt to ensure stable Indapamide supply?
Diversifying suppliers, establishing long-term contracts, conducting rigorous supplier audits, and maintaining strategic inventory reserves are crucial strategies.

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Sources

[1] Pharmaceutical Technology. "Global API Market Analysis." 2022.
[2] U.S. Food and Drug Administration. "API Supplier Validation Guidance." 2021.
[3] WHO. "Good Manufacturing Practices for Pharmaceuticals." 2019.
[4] European Medicines Agency. "Regulatory Requirements for API Manufacturing." 2022.
[5] Industry Reports. "Global Cardiovascular Drug Market," 2023.