Last updated: July 27, 2025
Introduction
Acetazolamide, a carbonic anhydrase inhibitor, is primarily prescribed to manage glaucoma, epilepsy, altitude sickness, and certain types of edema. As a vital component in treating these conditions, the global pharmaceutical supply chain for Acetazolamide is extensive, involving numerous suppliers ranging from active pharmaceutical ingredient (API) manufacturers to finished drug product distributors. Ensuring a secure and compliant supply chain is critical for healthcare providers, regulatory authorities, and pharmaceutical companies. This article provides a comprehensive overview of the key suppliers involved in the production, distribution, and supply of Acetazolamide.
Manufacturers of Acetazolamide API
Major API Producers
The foundation of the Acetazolamide supply chain resides in the API manufacturers. These companies synthesize the active compound based on validated chemical processes. Several prominent firms operate globally, manufacturing Acetazolamide APIs for export and local markets.
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Hikal Ltd. (India): A leading supplier with a significant share in the global API market, Hikal manufactures Acetazolamide API with high purity standards. The company complies with Good Manufacturing Practices (GMP) and supplies to both generic pharmaceutical producers and innovator companies. ([1])
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Wockhardt Ltd. (India): Known for its robust API manufacturing capacity, Wockhardt produces Acetazolamide with stringent quality controls, catering to diverse markets including North America and Europe. ([2])
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S.K. Chemicals (India): Specializing in pharmaceutical intermediates and APIs, S.K. Chemicals supplies Acetazolamide API primarily to generic drug manufacturers worldwide. ([3])
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Sachem Inc. (USA): An American chemical supplier, Sachem offers Acetazolamide API for research, development, and commercial manufacturing, emphasizing quality and regulatory compliance. ([4])
Emerging and Regional API Suppliers
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Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Increasingly active in the API market, Zhejiang Hisun manufactures Acetazolamide with an emphasis on cost-effective production, targeting Asia and emerging markets. ([5])
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Laurus Labs (India): Known for its integrated manufacturing facilities, Laurus produces high-quality Acetazolamide API for export and domestic markets, with recent expansion into advanced pharmaceutical intermediates. ([6])
Contract Manufacturing Organizations (CMOs)
Many pharmaceutical firms outsource Acetazolamide API production to CMOs to reduce costs and leverage specialized manufacturing processes.
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Lonza (Switzerland): A leading CMO providing high-quality API manufacturing solutions, Lonza offers custom synthesis and scale-up services for Acetazolamide. Their facilities adhere to international standards, ensuring regulatory compliance for global markets. ([7])
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Samsung BioLogics (South Korea): Increasingly involved in contract manufacturing, Samsung BioLogics offers API production capacity for molecules like Acetazolamide, emphasizing quality assurance and scalability. ([8])
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Cipla’s Contract Manufacturing Networks (India): Cipla often collaborates with regional CMOs to produce Acetazolamide for the Indian market and export. ([9])
Finished Dosage Form Manufacturers
Beyond the API suppliers, several pharmaceutical companies produce finished formulations of Acetazolamide, ensuring distribution to healthcare providers.
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Mylan (now part of Viatris): A major global generic manufacturer, Mylan produces Acetazolamide tablets for multiple markets, maintaining robust quality and supply chain standards. ([10])
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Teva Pharmaceutical Industries: As a leading generic drug manufacturer, Teva offers Acetazolamide in various dosages, with extensive distribution networks. ([11])
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Aurobindo Pharma: An Indian pharmaceutical giant, Aurobindo manufactures and supplies Acetazolamide tablets and capsules across continents. ([12])
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Sandoz (Novartis): Sandoz supplies Acetazolamide in generic formulations, leveraging its global footprint to ensure availability. ([13])
Distribution and Supply Chain Logistics
Ensuring consistent supply involves sophisticated logistics, including temperature-controlled shipping, regulatory compliance, and inventory management. Major distributors such as McKessons, AmerisourceBergen, and Alliance Healthcare facilitate the global distribution of Acetazolamide products, serving pharmacies, hospitals, and clinics across continents.
Regulatory Considerations
Manufacturers and suppliers must adhere to stringent regulatory frameworks:
- FDA (U.S. Food and Drug Administration)
- EMA (European Medicines Agency)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- WHO Prequalification Programs
These bodies require rigorous compliance with GMP, validation, stability, and quality standards for both APIs and finished products.
Market Dynamics and Risks
The supply chain for Acetazolamide faces risks such as geopolitical instability, regulatory delays, raw material shortages, and manufacturing disruptions. Dependency on Indian and Chinese API producers, although cost-effective, introduces vulnerabilities linked to regulatory and geopolitical tensions. Diversification of suppliers and transparent quality checks are essential to mitigate supply chain risks.
Key Players Summary
| Sector |
Notable Companies |
Regions |
Notes |
| API Manufacturing |
Hikal, Wockhardt, Sachem |
India, USA |
Market leaders with GMP compliance |
| Contract Manufacturing |
Lonza, Samsung BioLogics |
Switzerland, South Korea |
High-quality custom synthesis |
| Finished Dosage |
Mylan/Viatris, Teva |
Global |
Extensive distribution networks |
Conclusion
The supply chain for Acetazolamide is characterized by a diverse network of global API manufacturers, contract manufacturing organizations, and finished dosage form producers. Ensuring a reliable supply necessitates strategic sourcing, strict quality controls, and regulatory compliance. The key suppliers identified serve as pillars in maintaining the global availability of Acetazolamide, supporting healthcare systems worldwide.
Key Takeaways
- Diversify suppliers to mitigate risks associated with geopolitical or manufacturing disruptions.
- Prioritize GMP-compliant API suppliers for quality assurance.
- Engage with reputable CMOs for scalable and regulated API manufacturing.
- Maintain regulatory vigilance to ensure compliance with evolving standards.
- Invest in supply chain resilience through real-time monitoring and strategic inventory management.
FAQs
1. What are the primary regions manufacturing Acetazolamide APIs?
India and China dominate the production of Acetazolamide APIs due to cost advantages and manufacturing capacity. Companies like Hikal and Zhejiang Hisun are key providers.
2. Are there any risks associated with sourcing Acetazolamide from specific regions?
Yes. Dependence on suppliers from regions with geopolitical instability or regulatory differences can pose risks. Diversification and strict quality audits are recommended.
3. How do regulations impact Acetazolamide supply?
Regulatory standards like GMP compliance, registration, and approval processes influence manufacturing and distribution, with non-compliance risking delays or product recalls.
4. Can smaller pharmaceutical firms access Acetazolamide APIs?
Yes, through established API manufacturers and CMOs, provided they adhere to regulatory standards and meet quality specifications.
5. What trends are shaping the future supply of Acetazolamide?
Increasing focus on supply chain transparency, quality assurance, and geographic diversification are key trends to ensure continuous availability.
References:
[1] Hikal Ltd. Corporate Website. "API Manufacturing."
[2] Wockhardt Ltd. Annual Report. "API Production Capacity."
[3] S.K. Chemicals. Product Portfolio.
[4] Sachem Inc. Catalog.
[5] Zhejiang Hisun Pharmaceutical. Production Capabilities.
[6] Laurus Labs. Corporate Overview.
[7] Lonza. API Manufacturing Solutions.
[8] Samsung BioLogics. Contract Manufacturing Services.
[9] Cipla. Contract Manufacturing Network.
[10] Viatris Corporate Site. Product Portfolio.
[11] Teva Pharmaceuticals. API and Finished Products.
[12] Aurobindo Pharma. Product Portfolio.
[13] Sandoz. Product Offerings.
Note: Exact supplier details, capacities, and partnerships are subject to change based on market dynamics and company disclosures.
