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
Gland	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	219775	ANDA	Sagent Pharmaceuticals	25021-839-20	1 VIAL in 1 CARTON (25021-839-20) / 5 mL in 1 VIAL	2026-01-15
Gland	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	219775	ANDA	Gland Pharma Limited	68083-661-01	1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIAL	2025-06-17
Hikma	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	040089	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9006-01	1 VIAL in 1 CARTON (0143-9006-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1996-05-01
Hikma	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	040089	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9503-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1996-05-01
Mylan Asi	ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	200880	ANDA	Mylan Institutional LLC	67457-853-50	1 VIAL in 1 CARTON (67457-853-50) / 5 mL in 1 VIAL	2018-09-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies key suppliers of acetazolamide sodium active pharmaceutical ingredient (API), analyzes their manufacturing capabilities, and outlines regulatory compliance. The data is presented to inform R&D and investment decisions within the pharmaceutical sector.

Who are the Primary Manufacturers of Acetazolamide Sodium API?

Several companies globally produce acetazolamide sodium API. Manufacturing is concentrated in regions with established chemical synthesis infrastructure and regulatory oversight. The following suppliers are noted for their current or historical production:

Akorn, Inc.: While primarily a finished dosage form manufacturer, Akorn has historically been involved in API sourcing and development. Their involvement in the acetazolamide sodium supply chain is a factor in market dynamics.
Hikma Pharmaceuticals PLC: A global pharmaceutical company with API manufacturing capabilities, Hikma produces a range of generic injectables, including those requiring acetazolamide sodium.
Fresenius Medical Care AG & Co. KGaA: This company, a major provider of dialysis products and services, utilizes acetazolamide sodium. Their internal or contracted API production is a significant market component.
Teva Pharmaceutical Industries Ltd.: As one of the largest generic drug manufacturers, Teva is a substantial producer and consumer of various APIs, including acetazolamide sodium. Their global manufacturing footprint includes API synthesis facilities.
USP (United States Pharmacopeia): While not a manufacturer, USP provides the reference standard for acetazolamide sodium, crucial for quality control and regulatory submissions by API manufacturers and drug product companies.
Major generic API manufacturers in India and China: Numerous smaller to mid-sized companies in these regions are active in API synthesis. Specific company names frequently shift due to mergers, acquisitions, and market entry/exit. However, companies like Loba Chemie Pvt. Ltd. and Siyuan Scientific have appeared in supply chain analyses for related compounds.

These entities range from fully integrated pharmaceutical companies with in-house API production to specialized chemical manufacturers. The availability and price of acetazolamide sodium are influenced by the production capacity and competitive landscape of these suppliers.

What are the Key Manufacturing and Quality Control Standards for Acetazolamide Sodium API?

The production of acetazolamide sodium API adheres to stringent quality control measures and regulatory guidelines to ensure patient safety and drug efficacy. Key standards include:

Good Manufacturing Practices (GMP): All manufacturers must comply with current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This encompasses facility design, equipment validation, process control, personnel training, and documentation.
Pharmacopeial Standards: Acetazolamide sodium API must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These monographs detail identity, purity, assay, and impurity limits. For example, the USP monograph for Acetazolamide Sodium establishes specific tests and acceptance criteria for:
- Identification: Infrared absorption, sodium content.
- Assay: Typically by titration, requiring a specific percentage of acetazolamide.
- Impurities: Limits on related substances (e.g., acetazolamide), heavy metals, and residual solvents.
- Physical Characteristics: Appearance, solubility.
ICH Guidelines: International Council for Harmonisation (ICH) guidelines, particularly those related to impurities (ICH Q3A, Q3C, Q3D) and quality risk management (ICH Q9), are critical for API development and manufacturing. These guidelines standardize approaches to identifying, qualifying, and controlling impurities and for implementing a robust quality management system.
Batch-to-Batch Consistency: Manufacturers are required to demonstrate consistent quality across all production batches. This involves rigorous in-process controls and final product testing.
Stability Testing: API suppliers must conduct stability studies according to ICH Q1A to determine the shelf life and recommended storage conditions for acetazolamide sodium.

Manufacturers' adherence to these standards is typically verified through regulatory inspections and the issuance of Certificates of Analysis (CoAs) for each API batch.

Which Regulatory Bodies Oversee Acetazolamide Sodium API Manufacturing?

The manufacturing and distribution of acetazolamide sodium API are governed by multiple national and international regulatory authorities. These bodies ensure that the API meets established safety, efficacy, and quality standards. Key regulatory bodies include:

U.S. Food and Drug Administration (FDA): The FDA regulates APIs intended for use in the United States. Manufacturers must comply with FDA cGMP regulations and may be subject to facility inspections. Drug master files (DMFs) are often submitted to the FDA to provide confidential detailed information about facilities, processes, or articles used in manufacturing, processing, packaging, and storing of human drugs.
European Medicines Agency (EMA) and National Competent Authorities (NCAs) in EU Member States: In the European Union, the EMA coordinates the evaluation of medicines, but national agencies are responsible for GMP inspections and marketing authorization. APIs used in EU-marketed drugs must comply with EU GMP. Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) are often used to demonstrate compliance.
Pharmaceuticals and Medical Devices Agency (PMDA) in Japan: The PMDA oversees pharmaceutical regulations in Japan, requiring compliance with Japanese GMP standards for APIs.
Therapeutic Goods Administration (TGA) in Australia: The TGA regulates pharmaceuticals in Australia, including API manufacturing standards.
Health Canada: This agency is responsible for the regulation of drugs in Canada, including API quality and GMP compliance.
Other National Regulatory Authorities: Each country where the finished drug product is marketed will have its own regulatory body responsible for approving and inspecting API manufacturing sites and ensuring compliance with local regulations and pharmacopoeial standards.

Supplier qualification processes by pharmaceutical companies typically involve reviewing regulatory filings, audit reports, and Certificates of Analysis from API manufacturers to confirm compliance.

What is the Typical Lead Time and Pricing Structure for Acetazolamide Sodium API Orders?

The lead time and pricing for acetazolamide sodium API are subject to several variables, including order volume, supplier inventory levels, manufacturing schedules, and geopolitical factors affecting raw material sourcing and global logistics.

Lead Times:
- Standard Orders (e.g., kilograms): Typically range from 4 to 12 weeks from order placement to delivery. This accounts for batch production, quality control testing, and shipping.
- Large Contract Orders (e.g., metric tons): May require longer lead times, potentially 12 to 24 weeks, due to the need to schedule large-scale production runs and secure raw materials.
- Ex-Stock Availability: In rare cases, small quantities might be available for immediate shipment if a supplier maintains safety stock.
Pricing Structure:
- Volume Discounts: The per-kilogram price of acetazolamide sodium API generally decreases significantly with larger order quantities.
- Contract Pricing: Long-term supply agreements often include negotiated pricing that may be more favorable than spot market rates, providing price stability.
- Raw Material Costs: Fluctuations in the cost of key starting materials and reagents directly impact API pricing.
- Regulatory Compliance Costs: Investments in GMP compliance, quality systems, and regulatory filings are factored into the API price.
- Geographic Location of Supplier: Manufacturing costs and shipping expenses can vary by region, influencing the final price. For example, APIs sourced from India or China may have different pricing dynamics compared to those produced in Western Europe or North America.
- Purity and Grade: API sold for pharmaceutical use must meet strict purity standards, which can command higher prices than technical-grade chemicals.

Indicative Pricing Ranges (Subject to Significant Variation):

Small quantities (e.g., 1-10 kg): Can range from $150 to $400 per kilogram.
Bulk quantities (e.g., >100 kg): Prices can drop to $50 to $150 per kilogram, depending on the supplier and contract terms.

It is crucial for procurement professionals to solicit quotes from multiple qualified suppliers and to factor in total landed cost, including shipping, duties, and potential quality assurance expenses.

What are the Market Trends and Future Outlook for Acetazolamide Sodium API?

The market for acetazolamide sodium API is primarily driven by the demand for its finished pharmaceutical products, which are used to treat glaucoma, epilepsy, altitude sickness, and certain types of edema. Key market trends and outlook include:

Stable Demand from Established Indications: The primary therapeutic uses of acetazolamide sodium have long-standing patient populations, ensuring consistent, albeit not rapidly growing, demand for the API. The prevalence of conditions like glaucoma and epilepsy contributes to this baseline demand.
Generic Market Dominance: Acetazolamide sodium is a well-established molecule with expired patents, making it a commodity in the generic pharmaceutical market. This leads to price competition among API manufacturers.
Growth in Emerging Markets: As healthcare access and infrastructure improve in emerging economies, the demand for generic pharmaceuticals, including those containing acetazolamide sodium, is expected to increase.
Potential for New Indications and Research: While acetazolamide sodium is an older drug, ongoing research into its potential applications in other conditions could lead to new therapeutic uses and, consequently, increased API demand. For instance, research into its role in managing certain neurological disorders or fluid balance issues continues.
Supply Chain Diversification and Resilience: Recent global events have highlighted the importance of robust and diversified supply chains. Pharmaceutical companies are increasingly seeking to mitigate risks by qualifying multiple API suppliers across different geographic regions, potentially leading to increased opportunities for manufacturers in various countries.
Regulatory Scrutiny: Ongoing and increasing regulatory scrutiny on API quality and manufacturing practices, particularly regarding impurities and environmental impact, means that suppliers must continuously invest in compliance and advanced manufacturing technologies. This may lead to consolidation among smaller, less compliant manufacturers.
Technological Advancements in Synthesis: While acetazolamide sodium synthesis is a mature process, minor improvements in yield, purity, or environmental footprint could provide competitive advantages to API manufacturers.

The overall outlook for acetazolamide sodium API is one of steady demand, with growth potential tied to market expansion and possible new therapeutic discoveries. The market will continue to be characterized by price sensitivity and a strong emphasis on regulatory compliance and supply chain reliability.

Key Takeaways

Manufacturing of acetazolamide sodium API is global, with significant presence in India and China, alongside established players in Europe and North America.
Compliance with cGMP, pharmacopoeial standards (USP, Ph. Eur.), and ICH guidelines is mandatory for API suppliers.
Lead times for API orders typically range from 4 to 12 weeks, with pricing exhibiting significant volume discounts.
The market for acetazolamide sodium API is stable, driven by its established generic applications, with potential for growth in emerging markets and through ongoing research.

Frequently Asked Questions

What is the primary therapeutic use driving demand for acetazolamide sodium API? The primary therapeutic uses are the treatment of glaucoma, epilepsy, altitude sickness, and certain types of edema.
Are there any significant patent barriers for current acetazolamide sodium API manufacturers? Acetazolamide sodium is a well-established molecule, and its original patents have expired, leading to a generic market with no significant patent barriers for API manufacturers.
How does the purity of acetazolamide sodium API impact its price? Higher purity grades, meeting stringent pharmacopoeial requirements for pharmaceutical use, command higher prices compared to technical-grade chemicals due to the rigorous purification and testing processes involved.
What are the main risks associated with sourcing acetazolamide sodium API from a single supplier? Risks include potential supply disruptions due to manufacturing issues, regulatory non-compliance, geopolitical events, or natural disasters, which could lead to shortages and price volatility.
Can acetazolamide sodium API be used in veterinary medicine, and does this impact its market? While primarily used in human medicine, acetazolamide sodium may also have applications in veterinary medicine. The extent of this use and its impact on the overall API market are typically secondary to human pharmaceutical demand.

Citations

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF). U.S. Pharmacopeia.

[2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. EDQM.

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. ICH.

Suppliers and packagers for ACETAZOLAMIDE SODIUM