Bulk Pharmaceutical API Sources for BENZTHIAZIDE

Bulk Pharmaceutical API Sources for BENZTHIAZIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2343
Sigma-Aldrich		B7149_ALDRICH
MolPort		MolPort-003-666-130
MolPort		MolPort-003-940-508
AAA Chemistry		AR-1H9302
ABI Chem		AC1L1DGU
ABI Chem		AC1Q6TPO

Bulk Active Pharmaceutical Ingredient (API) Sources for: Benzthiazide

Last updated: July 27, 2025

Introduction

Benzthiazide, a thiazide-class diuretic, is predominantly used in managing hypertension and edema associated with heart failure or renal impairment. Its chemical structure, pharmacodynamic profile, and clinical efficacy depend significantly on the quality of its Active Pharmaceutical Ingredient (API). Ensuring a reliable and high-quality API supply is crucial for pharmaceutical manufacturers. This article provides a comprehensive overview of bulk Benzthiazide sources, examining key suppliers, manufacturing locations, regulatory considerations, and supply chain dynamics relevant for stakeholders.

Overview of Benzthiazide API

Benzthiazide (C9H9N3O4S2) is a sulfonamide derivative with diuretic properties. Its synthesis involves complex chemical processes requiring stringent quality controls to meet pharmacopeial standards. As a less commonly manufactured diuretic compared to hydrochlorothiazide, Benzthiazide's API sourcing landscape is relatively niche, comprising specialized chemical and bulk API manufacturers.

Global API Manufacturers of Benzthiazide

1. Established API Suppliers

a. Zhejiang Hemei Pharmaceutical Co., Ltd. (China)
Hemei Pharmaceutical has been recognized for its synthesis and export of various diuretics, including Benzthiazide. The company maintains Good Manufacturing Practice (GMP) certification, meeting international standards for pharmaceutical ingredients. Leveraging advanced synthesis techniques, they supply large batches to global pharmaceutical firms, primarily targeting Asian and North American markets.

b. Zhejiang Yiding Pharmaceutical Co., Ltd. (China)
Specializing in sulfonamide and diuretic APIs, Zhejiang Yiding offers Benzthiazide with a focus on high purity and batch consistency. Their manufacturing facilities adhere to international regulatory standards, making their products suitable for API use in branded and generic medications.

c. Shandong Xinhua Pharmaceutical Co., Ltd. (China)
Xinhua Pharmaceutical possesses a diversified portfolio, including diuretics. Their Benzthiazide API production benefits from vertical integration, controlling quality from synthesis to packaging, compliant with CE, USFDA, and European EMA standards.

d. Dales Chemicals (India)
Dales Chemicals is a prominent Indian API manufacturer with capabilities spanning various pharmaceutical intermediates and APIs. Their Benzthiazide API manufacturing is GMP-certified, with export experience across Europe, North America, and emerging markets.

2. Specialty API Manufacturers

a. Akorn Ingredients (USA)
While primarily known for finished dosage forms, Akorn Ingredients provides high-quality APIs, including Benzthiazide, to international clients seeking reliable North American supply sources.

b. TP Vectra Pharmaceuticals (India)
Specializing in research chemicals and APIs, TP Vectra produces Benzthiazide compliant with international standards, emphasizing R&D and customization for pharmaceutical companies.

Supply Chain and Sourcing Dynamics

The sourcing of Benzthiazide API involves navigating complex supply chains characterized by regional specialization. Chinese manufacturers dominate global API manufacturing, including Benzthiazide, due to scale, cost advantages, and manufacturing infrastructure. Indian companies also hold significant market shares, driven by competitive pricing and compliance with global standards.

However, sourcing from these suppliers requires rigorous quality assurance, including Certificate of Analysis (CoA), stability data, and regulatory compliance documentation. Because Benzthiazide APIs are not as widely produced as other diuretics, supply consistency can be a concern, necessitating multiple supplier relationships or engaging with API intermediaries.

Regulatory Considerations

Pharmaceutical companies sourcing Benzthiazide APIs must ensure adherence to Good Manufacturing Practices (GMP) and regulatory approvals in target markets. Agencies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and China's NMPA impose strict compliance requirements, impacting supplier selection.

Manufacturers should verify the API suppliers’ certifications, batch testing protocols, and Track & Trace capabilities. Importantly, the API's compatibility with regulatory filings influences procurement decisions, emphasizing the need for detailed quality documentation and stability data.

Emerging Trends and Challenges

• Supply Chain Disruptions: The COVID-19 pandemic underscored vulnerabilities in global API sourcing, prompting pharmaceutical firms to diversify their supplier base or consider local manufacturing options.
• Regulatory Scrutiny: Increasing pharmacovigilance and quality standards raise bar for API manufacturers, compelling continuous investment in manufacturing technology and quality systems.
• Environmental and Sustainability Standards: Manufacturers adopting environmentally sustainable processes gain competitive advantage, aligning with global ESG expectations.

Conclusion

Securing a reliable, compliant source of Benzthiazide API demands strategic sourcing decisions backed by thorough supplier vetting, regulatory compliance checks, and supply chain resilience planning. Chinese and Indian manufacturers currently dominate the market, offering cost-effective and GMP-compliant APIs suitable for global pharmaceutical production. Pharmaceutical companies must establish robust partnerships with trusted suppliers to mitigate risks associated with supply interruptions and ensure product quality.

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Key Takeaways

• The primary producers of Benzthiazide API are based predominantly in China and India, with a handful of North American suppliers.
• Regulatory compliance and GMP certification are critical factors in supplier selection for pharmaceutical manufacturing.
• Sourcing diversification can mitigate supply chain risks amid geopolitical or pandemic-induced disruptions.
• Robust quality assurance processes and supplier audits are essential for maintaining API specifications.
• Increasing emphasis on environmental standards signals a shift toward more sustainable API manufacturing practices.

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FAQs

Q1: What are the main regions manufacturing Benzthiazide API?
A: China and India dominate Benzthiazide API production, with North American companies serving niche or high-standard markets.

Q2: How do I verify the quality of Benzthiazide API from a supplier?
A: Request comprehensive Certificates of Analysis, GMP certification, stability data, and ensure compliance with pharmacopeial standards like USP or EP.

Q3: Are there any risks associated with sourcing Benzthiazide API from Chinese manufacturers?
A: Potential risks include quality variability, supply chain disruptions, and regulatory differences; due diligence and supplier audits mitigate these risks.

Q4: How has COVID-19 impacted Benzthiazide API supply?
A: The pandemic caused temporary shortages and supply chain bottlenecks, prompting diversification of suppliers and increased inventory buffering.

Q5: What future trends could influence Benzthiazide API sourcing?
A: Increased regulatory scrutiny, sustainability practices, and digital traceability are shaping API sourcing and quality assurance strategies.

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References

1. [1] U.S. Pharmacopeia. Chemistry, Manufacturing, and Controls (CMC) Requirements for API Suppliers. USP, 2022.
2. [2] European Medicines Agency. Guidelines on API Manufacturing Standards, 2021.
3. [3] Global Industry Analysts. API Market Report: Diuretics and Sulfonamides, 2021.
4. [4] Pharmaceutical Technology. Post-Pandemic Supply Chain Strategies for APIs, 2022.
5. [5] China National Medical Products Administration (NMPA). API Regulatory Guidelines, 2022.