Bulk Pharmaceutical API Sources for DIURIL

Bulk Pharmaceutical API Sources for DIURIL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C4911_SIGMA
TCI (Tokyo Chemical Industry)		C2259
Molport		MolPort-003-666-143
Molport		MolPort-003-845-912

Bulk Active Pharmaceutical Ingredient (API) Sources for: DIURIL (Chlorothiazide)

Last updated: July 30, 2025

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Introduction

Diuril, the brand name for chlorothiazide, is a thiazide diuretic primarily prescribed for hypertension and edema management. As an essential component of pharmaceutical formulations, high-quality bulk API sourcing is critical for manufacturers aiming to sustain efficacy, safety, and regulatory compliance. This report offers a comprehensive analysis of global sources for chlorothiazide API, emphasizing supplier reliability, regulatory standards, and market dynamics.

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Overview of Chlorothiazide (DIURIL) API

Chlorothiazide is a widely used antihypertensive agent introduced in the 1950s, renowned for its diuretic mechanism via inhibition of sodium reabsorption in the distal tubules of the kidney. The API must meet strict purity criteria, with impurities strictly regulated in line with pharmacopeial standards such as USP, EP, and JP.

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Global API Manufacturing Hubs for Chlorothiazide

1. India: A Leading Source of Chlorothiazide API

India’s pharmaceutical sector dominates the API landscape, accounting for approximately 60% of global generic API supplies. Major Indian API manufacturers possess scaled facilities with consistent compliance to cGMP regulations.

• Key Manufacturers:

  • Lupin Pharmaceuticals: Recognized for robust compliance and extensive export of chlorothiazide API to North America and Europe.
  • Dr. Reddy’s Laboratories: Offers high-purity chlorothiazide, certified by major regulatory agencies.
  • Aurobindo Pharma: Known for cost-effective supply coupled with quality standards aligned to international regulations.

• Regulatory Compliance: Indian producers often obtain approvals from U.S. FDA, EMA, and WHO, bolstering their export credibility. Many facilities are certified under WHO-GMP and ISO standards.

• Supply Stability & Capacity: These manufacturers maintain substantial production capacities, with some exceeding 100 metric tons annually, capable of satisfying global demand.

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2. China: Emerging API Supplier Ecosystem

China’s pharmaceutical API manufacturing sector has expanded rapidly, with several firms focusing on thiazide diuretics like chlorothiazide.

• Major Players:

  • Hubei Wufeng Pharmaceutical Co., Ltd.
  • Shandong Xinhua Pharmaceutical: Noted for competitive pricing and expanding GMP-compliant facilities.
  • Jiangsu Hengrui Medicine: Known for high-quality APIs with potential for strategic partnerships.

• Market Dynamics: Chinese API producers often emphasize affordability and flexible production scales, making them attractive, especially for markets with price sensitivity.

• Regulatory Access: Increasingly, Chinese API manufacturers seek and achieve certifications such as GMP, with some gaining US FDA inspection approval, reducing regulatory barriers for export.

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3. Europe: Niche but Reliable Suppliers

While Europe’s share is smaller compared to India and China, top EU producers focus on premium quality API supply with stringent quality controls.

• Notable Companies:

  • BASF (Germany): Offers high-purity chlorothiazide APIs tailored for high-end markets.
  • Lonza (Switzerland): Known for custom synthesis and stringent quality assurance.

• Market Position: EU suppliers are preferred for markets requiring strict regulatory oversight due to their advanced quality systems, though they often command premium pricing.

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Emerging and Specialized API Suppliers

Small-scale manufacturers and custom synthesis firms are gaining traction, especially in regions like Korea and Southeast Asia, providing niche, high-purity APIs for specialized applications.

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Regulatory Considerations

API integrity is paramount. Suppliers must demonstrate compliance with international standards:

• Good Manufacturing Practices (GMP) Certification: Essential for regulatory approval in major markets.
• ICH Guidelines: Ensures safety, quality, and efficacy.
• Documentation & Batch Traceability: Prefers suppliers with comprehensive supply chain transparency.

An increasing focus on Quality by Design (QbD) and robust impurity profiles underscores the importance of choosing suppliers compliant with the latest standards.

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Market Dynamics and Procurement Strategies

• Price Sensitivity: Indian and Chinese manufacturers offer competitive pricing, though buyers must verify quality certifications.
• Regulatory Status: Suppliers with established regulatory approvals facilitate smoother registration processes.
• Supply Chain Stability: Longer-term contracts with diversified suppliers mitigate risks of shortages.
• Technological Capabilities: Manufacturers employing advanced synthesis methods and analytical testing techniques deliver superior quality APIs aligned with regulatory expectations.

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Recent Industry Trends

• Increased Quality Standards: Suppliers upgrading facilities to meet stricter global standards.
• Supply Chain Diversification: Companies seek multiple sources to counter geopolitical and pandemic-related disruptions.
• Sustainable Practices: Growing emphasis on environmentally sustainable manufacturing processes.

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Conclusion

The global landscape for chlorothiazide API sourcing is dynamic, with India and China leading the supply chain due to their manufacturing scale and cost advantages. European suppliers remain the choice for clients prioritizing high regulatory confidence and premium quality. An optimal procurement strategy balances cost, quality, regulatory compliance, and supply stability, ensuring consistent access to high-quality DIURIL API.

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Key Takeaways

• India dominates as the primary bulk API supplier for chlorothiazide, offering quality and cost advantages.
• Chinese manufacturers provide competitive pricing but require rigorous quality verification and regulatory certification checks.
• European suppliers focus on high-end markets due to stringent quality assurances, though at higher costs.
• Regulatory compliance (GMP, ICH, and pharmacopeial standards) is critical for sourcing APIs that meet global pharma requirements.
• Diversifying suppliers and establishing long-term partnerships mitigate supply chain risks amidst geopolitical and logistical uncertainties.

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FAQs

Q1: What are the primary regulatory standards for sourcing chlorothiazide API?
A1: Common standards include USP, EP, JP, and compliance with GMP, ICH guidelines, and certifications from agencies like US FDA, EMA, and WHO.

Q2: How can manufacturers ensure the quality of bulk chlorothiazide API?
A2: Verify supplier certifications, review batch testing reports, conduct audits, and confirm compliance with pharmacopeial specifications for purity, impurity profile, and stability.

Q3: Are there specific challenges when sourcing APIs from China?
A3: Challenges include variability in quality control, potential delays in regulatory approvals, and differing manufacturing standards. Due diligence and supplier audits are essential.

Q4: What factors influence pricing differences across regions?
A4: Factors include manufacturing costs, scale of production, quality certifications, regulatory compliance levels, and logistical expenses.

Q5: What future trends are expected in API sourcing for diuretics like chlorothiazide?
A5: Increasing regulatory stringent standards, adoption of sustainable manufacturing practices, diversification of supply chains, and integration of digital supply chain monitoring are anticipated.

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References

1. U.S. Pharmacopeia (USP). Monograph on Chlorothiazide.
2. European Pharmacopoeia (EP). Monograph on Chlorothiazide.
3. Pharmaceutical Business Intelligence Reports, 2022.
4. GlobalAPI Market Analysis, IQVIA, 2023.
5. World Health Organization (WHO) GMP standards.