Bulk Pharmaceutical API Sources for DIAMOX

Bulk Pharmaceutical API Sources for DIAMOX

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A6011_SIGMA
Molport		MolPort-001-783-578
Hangzhou APIChem Technology		AC-12779
AKos Consulting & Solutions		AKOS000715163
Amadis Chemical		A832415
TimTec		SBB056640

Bulk Active Pharmaceutical Ingredient (API) Sources for: DIAMOX (Acetazolamide)

Last updated: July 30, 2025

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Introduction

Diamox, the brand name for Acetazolamide, is a carbonic anhydrase inhibitor primarily used to treat glaucoma, altitude sickness, epilepsy, and certain cases of edema. As a critical therapeutic agent, the demand for high-quality Acetazolamide APIs remains robust. The global pharmaceutical supply chain relies on reputable bulk API manufacturers to ensure consistent quality, regulatory compliance, and reliable delivery. This article provides a comprehensive overview of key bulk API sources for Acetazolamide, focusing on established manufacturers, geographic considerations, and sourcing strategies advantageous for pharmaceutical companies.

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Overview of Acetazolamide API Manufacturing

Acetazolamide's synthesis involves multiple chemical steps, including the formation of the sulfonamide core structure, with strict control over process parameters to optimize yield and purity. API manufacturing for Acetazolamide must adhere to Good Manufacturing Practices (GMP), and suppliers should possess regulatory approvals such as FDA, EMA, or other relevant authorities.

The API market for Acetazolamide is segmented among reputable producers, primarily based in Asia, Europe, and North America. These regions host pharmaceutical manufacturers with proven track records, consistent quality assurance, and robust supply chain infrastructures.

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Major Sources of Bulk Acetazolamide API

1. Chinese Manufacturers

China remains the dominant supplier for many bulk APIs, including Acetazolamide. Leading Chinese API producers offer cost-competitive options with extensive manufacturing capacities. Notable Chinese API manufacturers include:

• Hubei Jusheng Technology Co., Ltd.
  Known for producing a wide portfolio of sulfonamide APIs, including Acetazolamide, with GMP-certified facilities and export licenses. The company emphasizes regulatory compliance and reliable batch consistency.

• Shandong Xinhua Pharmaceutical Company Ltd.
  Offers Acetazolamide API with a focus on quality control and competitive pricing. Their manufacturing processes are compliant with international standards, with certifications such as ISO and GMP.

• Shenzhen JJB Pharmaceutical Co., Ltd.
  Specializes in various pharmaceutical intermediates and APIs. They supply bulk Acetazolamide to global pharmaceutical firms and contract manufacturers.

Note: Users should ensure proper due diligence regarding regulatory approvals and quality assurance when sourcing from Chinese suppliers, given regional variability.

2. Indian API Manufacturers

India's pharmaceutical industry is renowned for its robust API manufacturing capabilities, especially in central and southern regions. Prominent Indian suppliers include:

• BASF India Ltd.
  A subsidiary of the global chemical giant, BASF India provides high-quality Acetazolamide API produced under strict GMP conditions, with certifications aligning with international standards.

• Lloyds Pharmaceuticals Pvt. Ltd.
  An established manufacturer with a focus on sulfonamide APIs, offering Acetazolamide batches conforming to pharmacopeia standards (USP, BP, EP).

• Sanan Bio-Pharma Inc.
  Known for innovations in sulfonamides, Sanan supplies acetazolamide as part of their API portfolio, emphasizing high purity and consistency.

Advantages: Indian manufacturers often provide high-quality APIs with reliable regulatory compliance, competitive pricing, and extensive supply chain logistics.

3. European API Manufacturers

While fewer in number, European API suppliers focus on premium quality, stringent regulatory adherence, and specialized formulations. Key players include:

• Unigist Ltd. (France)
  Provides high-purity Acetazolamide API, suitable for neuropharmaceutical and ophthalmic formulations, with detailed documentation and regulatory support.

• TEVA Pharmaceuticals (Israel/Europe)
  A major global generic manufacturer with API manufacturing capabilities, including Acetazolamide, adhering to strict GMP standards, and extensive regulatory approvals.

• Recipharm (Sweden)
  Offers custom synthesis and API manufacturing services, including acetazolamide, with a focus on stability, purity, and batch-to-batch consistency.

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Emerging Suppliers and Contract Manufacturers

In addition to traditional manufacturers, Contract Development and Manufacturing Organizations (CDMOs) globally offer tailored API production capabilities. Notably:

• Samsung BioLogics (South Korea)
  Specializes in high-volume API synthesis with advanced quality control systems, providing scalable supply options.

• Cayman Chemical (USA)
  Offers high-purity Acetazolamide API primarily for research, with some bulk supply capabilities for clinical and limited commercial use.

• Lonza (Switzerland)
  Provides custom API manufacturing with extensive regulatory support, emphasizing complex chemistry and high-quality standards.

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Criteria for Selecting API Suppliers for Acetazolamide

When sourcing Acetazolamide API, pharmaceutical companies should evaluate:

• Regulatory compliance: Ensure suppliers possess GMP certificates, and APIs are compliant with pharmacopeias (USP, BP, EP).

• Quality assurance: Certificates of Analysis (COA), purity levels (>99%), batch consistency, and stability data.

• Manufacturing certifications: ISO, cGMP, and relevant health authority approvals.

• Supply reliability: Production capacity, lead times, and backup sources.

• Pricing and scalability: Competitive costs aligned with quality assurances.

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Cost Considerations and Supply Chain Dynamics

Chinese and Indian suppliers generally offer lower-cost APIs due to regional manufacturing economies. However, North American and European suppliers may command premiums reflecting higher regulatory compliance standards and stricter quality control. Supply chain considerations include geopolitical factors, export restrictions, and logistical costs.

Given the global emphasis on supply chain resilience post-pandemic, diversifying sources and establishing multiple supplier relationships can mitigate risks associated with geopolitical tensions, regulatory changes, or regional disruptions.

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Regulatory and Quality Assurance Implications

Regulatory agencies like the FDA, EMA, and PMDA scrutinize API manufacturing practices. Suppliers with approved manufacturing sites and consistent documentation aid in seamless product registration and importation. Collaboration with international suppliers should involve rigorous validation, clear communication of quality standards, and adherence to evolving regulatory requirements.

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Key Considerations for Business Professionals

• Prioritize suppliers with verified GMP certifications and pharmacopeial compliance.
• Conduct comprehensive due diligence, including site audits and review of quality documentation.
• Establish backup sources to mitigate supply interruptions.
• Consider the geographic chain—regional suppliers may reduce shipping costs and lead times.
• Keep abreast of international trade policies affecting API import/export.

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Key Takeaways

• Diversify sourcing: Relying on multiple suppliers across regions enhances supply chain resilience.
• Prioritize quality: Ensure APIs meet stringent regulatory standards to avoid delays and compliance issues.
• Assess supplier certifications: GMP, ISO, and pharmacopeial validations are critical indicators of manufacturer reliability.
• Monitoring geopolitical developments: Regulatory and trade policies can impact API availability and costs.
• Leverage contract manufacturing: Contract manufacturers with robust quality systems can offer tailored solutions for API procurement.

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FAQs

1. What are the leading countries supplying Acetazolamide bulk APIs?
China and India are the predominant sources due to their extensive manufacturing capacities and cost advantages, while Europe and North America provide high-quality APIs with more stringent regulatory compliance.

2. How can I verify the quality of Acetazolamide API from a supplier?
Request Certificates of Analysis, batch stability data, manufacturing certifications (GMP, ISO), and conduct or review third-party audits when possible to confirm compliance with pharmacopeial standards.

3. Are there any concerns regarding sourcing APIs from Chinese manufacturers?
While cost-effective, some Chinese suppliers may have varying levels of regulatory compliance; hence, thorough due diligence, verification, and quality assurance are crucial.

4. What factors influence the choice of an API supplier for Acetazolamide?
Regulatory approval status, quality certifications, price, supply capacity, delivery lead times, and supplier reliability are primary considerations.

5. How does international trade regulation affect Acetazolamide API sourcing?
Trade restrictions, tariffs, and export controls can impact supply chain logistics, necessitating proactive compliance assessment and diversification of sources.

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References

[1] European Medicines Agency. Acetazolamide Summary of Product Characteristics.
[2] U.S. Pharmacopeia. Acetazolamide Monograph.
[3] Strategic sourcing reports from industry analysts on API manufacturing regions and market trends.
[4] Company websites and public disclosures of Chinese, Indian, and European API manufacturers.