Bulk Pharmaceutical API Sources for ZAROXOLYN

Bulk Pharmaceutical API Sources for ZAROXOLYN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M1195_SIGMA
Molport		MolPort-003-666-780
Amadis Chemical		A812099
BioChemPartner		BCPP000166
BioChemPartner		BCP9000920
AKos Consulting & Solutions		AKOS015897109

Bulk Active Pharmaceutical Ingredient (API) Sources for ZAROXOLYN (Methazolamide)

Last updated: July 28, 2025

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Introduction

ZAROXOLYN, known generically as methazolamide, is a carbonic anhydrase inhibitor primarily used for managing glaucoma and intracranial hypertension. As a therapeutic agent, its manufacturing integrity hinges on reliable sources of high-quality bulk APIs. This article explores the landscape of API sourcing for methazolamide, highlighting key suppliers, sourcing considerations, regulatory implications, and market trends to inform stakeholders involved in the procurement, manufacturing, or regulation of ZAROXOLYN.

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Overview of Methazolamide as an API

Methazolamide, chemically characterized as N-(4-methyl-1,3-thiazol-2-yl)acetamide, functions by reducing aqueous humor production, thereby alleviating intraocular pressure. The global demand for ZAROXOLYN remains moderate, but supply chain stability is crucial due to the drug’s niche yet vital therapeutic role.

Sourcing a reliable API is a critical challenge, especially given the necessity of stringent quality standards sustained by regulatory authorities such as the US FDA, EMA, and WHO. The variability in manufacturing standards between regions influences sourcing decisions, impacting quality, cost, and supply security.

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Global API Manufacturing landscape for Methazolamide

Domestic and International API Manufacturers

The bulk API market for methazolamide is predominantly served by companies based in Asia, particularly China and India. Both countries host a number of API manufacturers with established facilities compliant with Good Manufacturing Practices (GMP).

• China: China’s API industry is a major contributor to global supply, with several prominent manufacturers producing methazolamide API under GMP accreditation. Companies such as Zhejiang Huahai Pharmaceutical and North China Pharmaceutical Group Corporation have capabilities in synthesizing small-molecule APIs like methazolamide. Their production facilities typically adhere to WTO-GMP standards, ensuring compatibility with international regulatory pathways.

• India: Indian pharmaceutical firms such as Aarti Drugs and Mangalore-based Granules India are known for manufacturing a variety of small-molecule APIs, including methazolamide. These firms often benefit from cost advantages, extensive R&D capabilities, and certifications from regulatory bodies such as the US FDA and Europe’s EMA.

• Other regions: While less prominent, manufacturers in Eastern Europe and Southeast Asia also supply APIs, often catering to regional markets or export segments.

API Contract Manufacturing Organizations (CMOs) and Private Label Suppliers

Many pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) to produce methazolamide API, especially when scaling production or meeting regulatory demands. These CMOs provide tailored manufacturing, quality assurance, and regulatory compliance support, making them valuable partners, especially for novel or complex formulations.

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Primary Sourcing Considerations

Quality Assurance and Regulatory Compliance

Quality certification such as EMA GMP, US FDA approval, and WHO prequalification influences supplier selection. Suppliers must demonstrate consistent batch quality, robust analytical controls, and validated manufacturing processes.

Cost and Pricing

Cost factors in raw materials, labor, manufacturing scale, and regional economic variables influence API procurement. While Chinese and Indian suppliers often offer competitive pricing, premium costs are associated with higher-grade, GMP-certified sources.

Supply Chain Security

Due to geopolitical tensions, trade restrictions, and COVID-19 disruptions, diversifying supply sources and maintaining inventory buffers are vital. Dual sourcing from certified suppliers mitigates risks of shortages or quality lapses.

Environmental and Ethical Standards

Sourcing suppliers compliant with environmental regulations and responsible manufacturing practices is increasingly critical for corporate social responsibility and regulatory compliance.

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Major API Suppliers for ZAROXOLYN

Supplier Name	Location	Certification	Notable Attributes
Zhejiang Huahai Pharmaceutical	China	GMP, FDA	Large-scale production, established reputation
North China Pharmaceutical Group	China	GMP	Extensive API portfolio, reliable quality
Aarti Drugs	India	GMP, US FDA	Cost-effective, compliance credentials
Granules India	India	GMP	Flexible manufacturing capabilities
Zhuhai Bailing Pharmaceutical	China	GMP	Niche API manufacturing, chemical expertise

Note: This list is illustrative; comprehensive supplier listings should be verified through industry databases and supplier audits.

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Regulatory and Quality Implications

Given the critical use of ZAROXOLYN, APIs intended for pharmaceutical use must meet strict regulatory standards. The FDA’s Drug Master Files (DMFs) and Certificates of Suitability (CEPs) issued by the EMA serve as assurance frameworks for quality and regulatory confidence.

Manufacturers and procurers should prioritize suppliers with validated processes, comprehensive analytical data, and proven compliance history, reducing regulatory hurdles and ensuring product safety.

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Market Trends and Future Outlook

• Increasing transparency and traceability: Regulatory agencies emphasize supply chain transparency, influencing sourcing strategies to favor suppliers with robust documentation and traceability.

• Shift toward regional sourcing: To mitigate geopolitical risks, companies are increasingly exploring regional API sources, including Southeast Asia and South America.

• R&D-driven technological advancements: Innovations such as continuous manufacturing and process intensification promise higher yields, lower costs, and improved environmental sustainability.

• Sustainability and green chemistry: Suppliers adopting environmentally friendly practices are gaining favor, aligning with global sustainability goals.

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Conclusion

Reliable sourcing of methazolamide API is fundamental to the consistent manufacturing of ZAROXOLYN. Asia, particularly China and India, remains the primary hub, with numerous GMP-certified suppliers offering competitive options. Rigorous qualification processes, regulatory compliance, and risk mitigation strategies are essential to secure a stable API supply chain.

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Key Takeaways

• Asia dominates global API production, with China and India leading suppliers of methazolamide.
• Ensuring suppliers hold GMP or equivalent certifications is paramount for regulatory approval and product safety.
• Diversifying sources and maintaining strategic inventory buffers reduce supply chain risks amidst geopolitical and pandemic-related disruptions.
• Advances in manufacturing technology and sustainability initiatives are shaping the future of API sourcing.
• Collaborative engagement with reputable CMOs and continuous quality audits enhance supply chain integrity.

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FAQs

1. What are the primary regulatory requirements for sourcing methazolamide API?
Manufacturers must ensure API suppliers adhere to GMP standards recognized by authorities like the FDA and EMA. Certifications, batch documentation, analytical validation, and compliance with chemical safety regulations are critical.

2. How does geopolitical policy influence API sourcing for ZAROXOLYN?
Trade restrictions, tariffs, and political tensions can impact supply availability and cost, prompting companies to diversify sourcing regions and forge strategic partnerships in politically stable and compliant jurisdictions.

3. What are the key factors to evaluate when selecting an API supplier?
Quality certifications (GMP, FDA), compliance history, manufacturing capacity, analytical validation, cost, supply stability, environmental practices, and ability to meet regulatory requirements.

4. How are supply chain disruptions affecting the API market for ZAROXOLYN?
Disruptions from COVID-19 and geopolitical issues have led to shortages, delays, and cost increases, emphasizing the importance of supplier diversification and inventory management.

5. What future trends will impact API sourcing for methazolamide?
The shift toward greener manufacturing, increased regulatory oversight, technological innovation, and regional diversification are shaping the evolving landscape of API procurement.

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Sources

1. U.S. Food and Drug Administration. Drug Master Files (DMFs). https://www.fda.gov/drugs/drug-approvals-and-databases/drug-master-files
2. World Health Organization. WHO Prequalification Programme. https://www.who.int/groups/prequalification-of-friends-and-clients
3. PharmaCompass. API Manufacturer Directory. https://www.pharmacompass.com/
4. EvaluatePharma. Industry reports on API manufacturing trends.
5. Market Research Future. API Market Analysis Reports.

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