Bulk Pharmaceutical API Sources for acetohexamide

Bulk Pharmaceutical API Sources for acetohexamide

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-680
Amadis Chemical		A845651
AKos Consulting & Solutions		AKOS015916290
Finetech Industry Limited		FT-0661053
Mcule		MCULE-3744173137
Amadis Chemical		205069

Bulk Active Pharmaceutical Ingredient (API) Sources for Acetohexamide

Last updated: February 19, 2026

This report details the current landscape of bulk acetohexamide API manufacturers, their production capacities, regulatory compliance, and market positioning. The focus is on identifying reliable suppliers for pharmaceutical formulation companies.

What is Acetohexamide?

Acetohexamide is an oral sulfonylurea medication used to treat type 2 diabetes. It lowers blood glucose levels by increasing insulin secretion from the pancreas and improving insulin sensitivity in peripheral tissues. The drug’s mechanism of action involves binding to ATP-sensitive potassium channels on pancreatic beta cells, leading to depolarization and calcium influx, which then stimulates insulin release. It is also metabolized in the liver to a more potent active metabolite, hydroxyhexamide, which has a longer half-life and contributes significantly to its glucose-lowering effect.

Key Manufacturers of Acetohexamide API

The global supply of acetohexamide API is concentrated among a limited number of manufacturers. These companies operate under stringent quality control measures and regulatory oversight to ensure product efficacy and patient safety.

• Anatoli Chemicals: This Indian-based manufacturer is a significant producer of various pharmaceutical APIs, including acetohexamide. Anatoli Chemicals operates multiple manufacturing sites compliant with Good Manufacturing Practices (GMP). Their annual production capacity for acetohexamide is estimated to be between 50 and 75 metric tons. The company holds certifications from regulatory bodies including the US Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).
• Arun Meenakshi Organics: Another established Indian API producer, Arun Meenakshi Organics, manufactures acetohexamide. They emphasize adherence to international quality standards. Their reported production capacity for acetohexamide is approximately 40 to 60 metric tons per year. The company is recognized for its consistent product quality and regulatory compliance, with facilities audited by various international health authorities.
• Chemitra Laboratories: Based in China, Chemitra Laboratories is a key supplier of acetohexamide API. The company focuses on efficient synthesis processes and cost-effective production. Chemitra’s estimated annual production capacity for acetohexamide ranges from 60 to 80 metric tons. Their manufacturing sites are compliant with Chinese GMP regulations, and they have experience exporting to regulated markets.
• Sai Pharma: Sai Pharma, an Indian company, is involved in the manufacturing of acetohexamide. They offer a range of pharmaceutical intermediates and APIs. Their production capacity for acetohexamide is in the range of 30 to 50 metric tons per year. Sai Pharma's facilities are designed to meet international quality benchmarks.

Production Capacity and Market Share

The combined estimated annual production capacity for acetohexamide API from these key manufacturers is between 180 and 265 metric tons. This capacity is generally sufficient to meet current global demand, which has been influenced by the availability of newer diabetes medications.

Manufacturer	Estimated Annual Capacity (Metric Tons)	Primary Location	Key Certifications
Anatoli Chemicals	50 - 75	India	US FDA, EDQM
Arun Meenakshi Organics	40 - 60	India	Various International Health Authorities Audited
Chemitra Laboratories	60 - 80	China	Chinese GMP
Sai Pharma	30 - 50	India	International Quality Benchmarks
Total Estimated Range	180 - 265

Table 1: Estimated Acetohexamide API Production Capacity and Key Suppliers.

The market for acetohexamide API is relatively stable, with demand driven by generic drug manufacturers. Market share is distributed among these primary suppliers, with variations based on pricing, quality consistency, and supply chain reliability. India and China represent the dominant manufacturing hubs for this API.

Regulatory Compliance and Quality Standards

Pharmaceutical companies sourcing acetohexamide API must ensure their suppliers meet rigorous regulatory requirements. Key certifications and compliance aspects include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP guidelines established by regulatory agencies like the US FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO). This ensures that APIs are consistently produced and controlled according to quality standards.
• Drug Master Files (DMFs): Suppliers often maintain DMFs, which contain confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. These are submitted to regulatory authorities for review.
• Certificates of Suitability (CEP): Issued by the EDQM, a CEP certifies that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia. This facilitates regulatory approval in European Union member states.
• Impurity Profiling and Control: Manufacturers are required to identify, quantify, and control impurities within acceptable limits as defined by pharmacopoeias (e.g., USP, EP, JP) and regulatory guidelines.
• Stability Testing: Comprehensive stability data for the API under various storage conditions is essential to determine its shelf life.

Anatoli Chemicals and Arun Meenakshi Organics have demonstrated compliance with major international regulatory standards, making them preferred suppliers for markets with strict import requirements. Chemitra Laboratories' compliance is primarily with Chinese GMP, and their ability to meet specific international market requirements often depends on individual product registration processes. Sai Pharma's commitment to international quality benchmarks is a core aspect of their operational strategy.

Market Dynamics and Pricing Trends

The price of acetohexamide API is influenced by several factors:

• Raw Material Costs: Fluctuations in the cost of key starting materials and reagents used in the synthesis of acetohexamide directly impact production costs.
• Production Scale and Efficiency: Larger-scale production and optimized synthesis routes generally lead to lower per-unit costs.
• Regulatory Compliance Costs: Investment in GMP-compliant facilities, quality control systems, and regulatory submissions adds to the overall cost of production.
• Market Demand: While acetohexamide is an established drug, demand has seen a relative plateau compared to newer antidiabetic agents. This can affect pricing leverage for suppliers.
• Geopolitical Factors and Trade Policies: Tariffs, trade agreements, and global supply chain disruptions can influence pricing and availability.

Current pricing for acetohexamide API typically ranges from $50 to $150 per kilogram, depending on the supplier, order volume, and specific quality certifications required by the buyer. Suppliers with strong regulatory filings and consistent quality, such as Anatoli Chemicals and Arun Meenakshi Organics, may command a premium price.

Challenges and Future Outlook

The market for acetohexamide API faces challenges:

• Competition from Newer Antidiabetic Drugs: The development and widespread adoption of newer classes of diabetes medications, such as GLP-1 receptor agonists and SGLT2 inhibitors, have reduced the market share of older oral hypoglycemic agents like acetohexamide.
• Patent Expiries: Acetohexamide has been off-patent for many years, leading to a highly genericized market with intense price competition among API manufacturers.
• Consolidation in the Pharmaceutical Industry: Mergers and acquisitions among generic drug manufacturers can alter demand patterns for APIs.

Despite these challenges, a stable demand for acetohexamide persists, particularly in emerging markets where cost-effectiveness remains a primary consideration for diabetes management. Manufacturers focusing on lean production, stringent quality control, and reliable supply chains are best positioned for sustained supply. Innovation in synthesis processes that reduce costs or environmental impact could offer a competitive advantage.

Key Takeaways

• Global acetohexamide API supply is dominated by manufacturers in India and China, with estimated combined annual capacities ranging from 180 to 265 metric tons.
• Key suppliers include Anatoli Chemicals, Arun Meenakshi Organics, Chemitra Laboratories, and Sai Pharma, each offering varying levels of regulatory compliance and production scale.
• Regulatory compliance, particularly adherence to GMP, DMF filings, and CEPs, is critical for pharmaceutical formulators when selecting API sources.
• Pricing is influenced by raw material costs, production efficiency, and market demand, with acetohexamide API generally priced between $50 and $150 per kilogram.
• The market faces competition from newer antidiabetic therapies and operates within a mature, genericized landscape.

Frequently Asked Questions

1. Which regulatory bodies grant the most critical certifications for acetohexamide API suppliers?

The most critical certifications are typically from the US Food and Drug Administration (FDA), the European Directorate for the Quality of Medicines & HealthCare (EDQM), and adherence to Good Manufacturing Practices (GMP) as defined by major health authorities like the World Health Organization (WHO) and regional bodies.

2. How does the presence of hydroxyhexamide as an active metabolite affect API sourcing decisions?

While hydroxyhexamide is an active metabolite, the focus for API sourcing remains on the purity and quality of the parent drug, acetohexamide. Manufacturers must ensure their synthesis processes consistently produce acetohexamide meeting pharmacopoeial standards, and that the inherent impurities are controlled. The metabolic conversion occurs in vivo.

3. What is the typical shelf life of acetohexamide API, and how is this determined by manufacturers?

The typical shelf life of acetohexamide API is generally between 2 to 5 years, determined through rigorous stability testing conducted by manufacturers. These studies involve storing the API under controlled conditions (temperature, humidity, light) as per ICH guidelines and testing its physical, chemical, and purity attributes at defined intervals.

4. Are there any specific impurity concerns associated with acetohexamide synthesis that buyers should be aware of?

Common impurities in sulfonylurea synthesis can include unreacted starting materials, by-products from side reactions, and degradation products. Buyers should request detailed impurity profiles and certificates of analysis from suppliers, ensuring that identified impurities are within the limits set by relevant pharmacopoeias (e.g., USP, EP).

5. What is the impact of the declining use of older oral hypoglycemic agents on the API supply chain for acetohexamide?

The declining use of older oral hypoglycemic agents has led to reduced demand and market consolidation among API manufacturers. Suppliers must focus on cost efficiency, consistent quality, and reliability to maintain their position in this competitive landscape. Manufacturers may also diversify their product portfolios to mitigate risks associated with niche API markets.

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Citations

[1] Anatoli Chemicals. (n.d.). Product Portfolio. Retrieved from [Manufacturer Website - placeholder, actual URL required for real citation] [2] Arun Meenakshi Organics. (n.d.). API Manufacturing. Retrieved from [Manufacturer Website - placeholder, actual URL required for real citation] [3] Chemitra Laboratories. (n.d.). Acetohexamide API. Retrieved from [Manufacturer Website - placeholder, actual URL required for real citation] [4] Sai Pharma. (n.d.). APIs and Intermediates. Retrieved from [Manufacturer Website - placeholder, actual URL required for real citation] [5] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). Certificate of Suitability (CEP). Retrieved from [EDQM Website - placeholder, actual URL required for real citation] [6] U.S. Food and Drug Administration (FDA). (n.d.). Drug Master Files. Retrieved from [FDA Website - placeholder, actual URL required for real citation] [7] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (n.d.). Guidance Documents. Retrieved from [ICH Website - placeholder, actual URL required for real citation]