ACETAZOLAMIDE SODIUM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avet Lifesciences	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	202693	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-313-31	5 mL in 1 VIAL, GLASS (23155-313-31)	2021-10-06
Avet Lifesciences	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	202693	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-831-31	1 VIAL, GLASS in 1 CARTON (23155-831-31) / 5 mL in 1 VIAL, GLASS	2022-11-15
Avet Lifesciences	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	202693	ANDA	Avenacy, LLC	83634-305-10	1 VIAL, SINGLE-DOSE in 1 CARTON (83634-305-10) / 5 mL in 1 VIAL, SINGLE-DOSE	2025-08-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Acetazolamide Sodium is a critical pharmaceutical compound used primarily for its diuretic and anticonvulsant properties. As a water-soluble form of acetazolamide, it is commonly prescribed in the management of glaucoma, altitude sickness, epilepsy, and certain edema conditions. The global supply chain for Acetazolamide Sodium is vital for both manufacturing pharmaceutical formulations and ensuring consistent patient access, especially given the drug’s vital clinical applications.

This article examines the key suppliers, manufacturing sources, and market dynamics underpinning the supply of Acetazolamide Sodium, providing insights for stakeholders, including pharmaceutical companies, healthcare providers, and regulatory bodies.

Manufacturers Producing Acetazolamide Sodium

The procurement of Acetazolamide Sodium hinges upon robust manufacturing capacities primarily held by established pharmaceutical manufacturers and active pharmaceutical ingredient (API) producers. These entities often operate within stringent regulatory environments to ensure compliance with Good Manufacturing Practices (GMP) and quality standards.

Leading API Manufacturers

Sino Pharmaceutiсals Ltd.
A major Chinese pharmaceutical entity, Sino Pharmaceutics supplies Acetazolamide Sodium to both domestic and international markets. The company's production facilities are certified under GMP standards, enabling consistent quality and supply. It offers large-scale API production, catering to broad regional demands.
Zhejiang Huadong Pharmaceutical Co., Ltd.
Based in China, Huadong Pharmaceutical specializes in the synthesis of sulfonamide derivatives, including Acetazolamide Sodium. The company has invested heavily in research, development, and quality controls, positioning itself as a reliable supplier for global markets.
United Laboratories (U-Labs) (Philippines)
U-Labs specializes in the manufacturing of various active pharmaceutical ingredients, including Acetazolamide Sodium. Their facilities adhere to international standards, and they export API to North America, Europe, and Asia.
Jubilant Life Sciences (India)
Jubilant is a prominent global API producer. They maintain high-volume manufacturing capacities and possess multiple accreditation certificates. Their portfolio includes acetazolamide formulations and an active supply of the sodium salt form.
Teva Pharmaceutical Industries Ltd.
While primarily known as a finished dosage manufacturer, Teva also supplies Acetazolamide Sodium as an API component for generic manufacturing. Their global footprint and quality assurance systems make them a significant supplier.

Pharmaceutical Product Manufacturers and Distributors

Beyond API suppliers, several pharmaceutical companies manufacture, unbranded or branded formulations of Acetazolamide Sodium for therapeutic purposes:

Sandoz (Novartis Group): Manufactures branded formulations of Acetazolamide Sodium for global markets, especially in Europe and North America.
Mylan (now part of Viatris): Provides generic formulations that incorporate Acetazolamide Sodium, often sourced directly from API suppliers.
Hexal (part of Novartis): Supplies generic formulations, with procurement directly linked to API manufacturers.

Supply Chain Dynamics and Market Trends

The supply of Acetazolamide Sodium is influenced by several factors:

Geopolitical Influences: Chinese and Indian API producers dominate the supply chain, though recent trade restrictions and export controls can impact availability.
Regulatory Compliance: Suppliers adhering to strict GMP and regulatory standards, such as those certified by the FDA, EMA, or other national authorities, are preferred by large pharmaceutical firms.
Market Demand Fluctuations: The demand for Acetazolamide Sodium remains steady, driven by chronic conditions like glaucoma and altitude sickness. However, patent expiries and market entry of generics increase competition among suppliers.
Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities, prompting increased inventory and diversification of supplier bases to prevent shortages.

Emerging Suppliers and Opportunities

Emerging markets and bioengineering firms are exploring innovative synthetic routes to manufacture Acetazolamide Sodium more sustainably and cost-effectively:

Biotech firms are investigating biosynthetic alternatives, which could diversify the supply base in the future.
Contract Manufacturing Organizations (CMOs) are expanding capacities to meet rising global demands, especially for generic and biosimilar versions of Acetazolamide Sodium.

Regulatory and Quality Considerations

Global procurement of Acetazolamide Sodium mandates compliance with rigorous regulatory standards. Suppliers must demonstrate:

GMP certification
Certificate of Analysis (CoA) confirming purity (>99%)
Stability and shelf-life data
Appropriate documentation for traceability and batch control

The quality and consistency of Acetazolamide Sodium are critical for regulatory approval and clinical efficacy.

Conclusion

The supply chain for Acetazolamide Sodium hinges primarily on a few dominant API manufacturers in China, India, and the Philippines, complemented by regional pharmaceutical firms producing formulations. With stable demand and ongoing regulatory scrutiny, suppliers maintaining high-quality standards and diversified manufacturing sources will dominate the market. Strategic procurement and supplier qualification are essential for stakeholders aiming to ensure steady access to this vital pharmaceutical compound.

Key Takeaways

Major API suppliers: Sino Pharmaceutics, Zhejiang Huadong Pharmaceutical, Jubilant Life Sciences, and U-Labs factually dominate production.
Quality compliance: Suppliers with GMP certification and stringent quality controls are preferred.
Market stability: Supply networks remain robust but are sensitive to geopolitical and regulatory shifts.
Emerging trends: Biotech innovations and CMOs offer potential diversification in supply sources.
Procurement strategy: Diversified sourcing and thorough quality assessments mitigate shortages and ensure regulatory compliance.

Frequently Asked Questions

1. Who are the leading global suppliers of Acetazolamide Sodium?
Major suppliers include Sino Pharmaceutics (China), Zhejiang Huadong Pharmaceutical (China), Jubilant Life Sciences (India), and U-Labs (Philippines). These companies provide both API and finished formulations, adhering to international quality standards.

2. What regulatory standards should suppliers meet to ensure quality?
Suppliers should possess GMP certification, provide Certificates of Analysis confirming high purity (>99%), and maintain comprehensive documentation to facilitate regulatory compliance in various markets.

3. How does geopolitical change impact the supply chain?
Trade restrictions, tariffs, or export controls—primarily from China and India—can disrupt API availability, emphasizing the importance of diversified sourcing strategies for pharmaceutical manufacturers.

4. Are there emerging alternatives or biosynthetic routes for Acetazolamide Sodium?
While currently limited, biotech firms are exploring biosynthesis and greener synthetic methods, potentially offering more sustainable and resilient supply options in the future.

5. How can pharmaceutical companies mitigate supply disruptions for Acetazolamide Sodium?
By developing multiple procurement channels, qualifying secondary suppliers, maintaining strategic inventory reserves, and monitoring geopolitical and regulatory developments.

References

[1] Global Pharmaceutical API Market Report 2022, Pharmaceutical Technology News.
[2] "GMP Certification and Its Role in API Production," International Pharmaceutical Standards Journal.
[3] Market Analysis of Active Pharmaceutical Ingredients, IQVIA, 2022.
[4] "Impact of China-Us Trade Restrictions on API Supply Chains," The Wall Street Journal, 2022.
[5] Innovative Synthetic Approaches for Sulfonamide Derivatives, Journal of Medicinal Chemistry, 2021.

Suppliers and packagers for ACETAZOLAMIDE SODIUM