Suppliers and packagers for generic pharmaceutical drug: PENTAMIDINE ISETHIONATE

PENTAMIDINE ISETHIONATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	NEBUPENT	pentamidine isethionate	FOR SOLUTION;INHALATION	019887	NDA	Fresenius Kabi USA, LLC	63323-877-15	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE	2011-02-15
Seton Pharms	PENTAMIDINE ISETHIONATE	pentamidine isethionate	FOR SOLUTION;INHALATION	206667	ANDA	Seton Pharmaceuticals	13925-522-01	1 VIAL in 1 CARTON (13925-522-01) / 300 mg in 1 VIAL	2019-10-14
X-gen Pharms Inc	PENTAMIDINE ISETHIONATE	pentamidine isethionate	FOR SOLUTION;INHALATION	206983	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-3030-2	1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1)	2023-04-04
Fresenius Kabi Usa	PENTAM	pentamidine isethionate	INJECTABLE;INJECTION	019264	NDA	Fresenius Kabi USA, LLC	63323-113-10	10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01)	2001-01-16

Pentamidine Isethionate Supply Chain Analysis

Last updated: February 19, 2026

Pentamidine isethionate, a critical antiprotozoal and antiparasitic agent, faces a consolidated supply landscape. Key manufacturers and suppliers are primarily located in China and India, with limited Western-based production capacity. The isethionate salt form is standard for pharmaceutical applications. Demand is driven by its use in treating Pneumocystis pneumonia (PCP), leishmaniasis, and human African trypanosomiasis.

Who are the primary manufacturers of Pentamidine Isethionate?

The production of Pentamidine isethionate is concentrated among a small number of global chemical manufacturers. These entities specialize in the synthesis of active pharmaceutical ingredients (APIs) and intermediates.

• Chinese Manufacturers: Several companies in China are significant producers. These include:

  • Shaanxi Sanglin Health Technology Co., Ltd.: Based in Shaanxi Province, this company lists Pentamidine isethionate as part of its API portfolio [1].
  • Xi'an Natural Field Bio-Technique Co., Ltd.: Located in Xi'an, this firm is a known supplier of pharmaceutical intermediates and APIs, including Pentamidine isethionate [2].
  • Hubei Gedian Tianyuan Fine Chemical Co., Ltd.: This company has been identified as a producer of Pentamidine isethionate, contributing to the global supply [3].
  • Guangdong Hongda Pharmaceutical Co., Ltd.: While primarily known for other pharmaceutical products, Hongda has been cited in supply chain discussions related to Pentamidine isethionate [4].

• Indian Manufacturers: India also hosts key suppliers.

  • Cipla Limited: A major Indian pharmaceutical company, Cipla has historically been involved in the production and supply of Pentamidine isethionate, particularly for finished dosage forms [5].
  • Divi's Laboratories Limited: Though not always directly listed as a primary Pentamidine isethionate manufacturer for end-use, Divi's is a significant API producer and could be a supplier of intermediates or the API itself [6].

• Other Regions: Limited information suggests some smaller-scale or specialized production may exist in other regions, but these do not represent the bulk of global supply. Western European or North American manufacturers are not prominently identified as large-scale producers of the API itself, though they may be involved in formulation or distribution.

What is the typical purity and grade of commercially available Pentamidine Isethionate?

Pharmaceutical-grade Pentamidine isethionate must meet stringent purity requirements to be used in human therapeutics. The International Pharmacopoeia (Int. Ph. Eur.) and United States Pharmacopeia (USP) standards are the primary benchmarks.

• Purity Levels: Typically, Pentamidine isethionate for pharmaceutical use has a minimum purity of 98.0% to 101.0% on an anhydrous and solvent-free basis. This is determined by techniques such as High-Performance Liquid Chromatography (HPLC).
• Impurities: Limits are set for specific known impurities, including related substances, heavy metals, and residual solvents.
  • Related substances: The sum of unspecified impurities should not exceed 0.5%.
  • Heavy metals: Limits are generally set at or below 20 ppm.
  • Residual solvents: Solvents used in manufacturing must comply with ICH Q3C guidelines, with specific limits for common solvents like ethanol, methanol, and isopropanol.
• Physical Characteristics:
  • Appearance: It is a white or yellowish-white crystalline powder.
  • Solubility: Freely soluble in water and ethanol, practically insoluble in ether.
  • Water Content: Not more than 5.0% as determined by Karl Fischer titration.
• Pharmacopoeial Compliance: Suppliers generally indicate compliance with USP and/or EP monographs. For example, the USP monograph for Pentamidine Isethionate details specific tests and acceptance criteria [7].

What are the key regulatory considerations for Pentamidine Isethionate supply?

The supply of Pentamidine isethionate is governed by pharmaceutical regulatory frameworks, ensuring safety, efficacy, and quality.

• Good Manufacturing Practices (GMP): Manufacturers must adhere to cGMP standards as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. This includes robust quality management systems, process validation, and documentation.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory authorities. A DMF contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the API information without needing direct access to the proprietary details.
• Certificates of Analysis (CoA): Each batch of Pentamidine isethionate supplied must be accompanied by a CoA that details the test results against the agreed-upon specifications and pharmacopoeial standards.
• Import/Export Regulations: International trade of APIs requires compliance with the import and export regulations of both the originating and destination countries. This includes proper documentation, labeling, and adherence to customs requirements.
• Country-Specific Registrations: For use in finished drug products in specific markets, the API may need to be listed in national drug registries or have specific dossier submissions made to local health authorities.

What are the main applications and market drivers for Pentamidine Isethionate?

Pentamidine isethionate's therapeutic applications dictate its market demand.

• Pneumocystis Pneumonia (PCP): This is a primary driver. Pentamidine isethionate is used for both treatment and prophylaxis of PCP, particularly in immunocompromised individuals, such as those with HIV/AIDS. While newer treatments exist, it remains an important option, especially in resource-limited settings or when other therapies are contraindicated [8].
• Leishmaniasis: It is an established treatment for visceral and cutaneous leishmaniasis, particularly in regions where other first-line drugs are less effective or unavailable.
• Human African Trypanosomiasis (Sleeping Sickness): Pentamidine isethionate is effective against the early stage of Trypanosoma brucei gambiense infection.
• Market Dynamics:
  • Disease Prevalence: The incidence of PCP in specific patient populations (e.g., untreated HIV) and the prevalence of leishmaniasis and sleeping sickness in endemic regions directly influence demand.
  • WHO Essential Medicines List: Pentamidine isethionate is included on the World Health Organization (WHO) Model List of Essential Medicines, ensuring its availability and affordability in public health programs globally [9].
  • Competition: For PCP, trimethoprim-sulfamethoxazole is a widely used alternative. For leishmaniasis, miltefosine and liposomal amphotericin B are other therapeutic options. The availability, cost, and efficacy profiles of these alternatives impact Pentamidine isethionate's market share.
  • Global Health Initiatives: Programs focused on neglected tropical diseases and HIV/AIDS management often involve the procurement and distribution of Pentamidine isethionate, influencing supply chain volumes.

What are the potential supply chain risks and mitigation strategies for Pentamidine Isethionate?

The consolidated nature of Pentamidine isethionate manufacturing presents specific supply chain vulnerabilities.

• Geographic Concentration: Over-reliance on a limited number of manufacturers, primarily in China, creates risks related to geopolitical instability, trade disputes, or localized production disruptions (e.g., environmental regulations, facility closures).
  • Mitigation: Qualifying and maintaining relationships with multiple suppliers across different geographic regions. Diversifying the supplier base to include manufacturers in India or exploring opportunities for limited Western-based production for critical intermediates or the final API.
• Quality Control and Assurance: Ensuring consistent API quality from diverse global suppliers requires robust oversight. Batch-to-batch consistency is paramount for patient safety.
  • Mitigation: Implementing rigorous supplier auditing programs. Conducting independent batch testing by third-party laboratories. Requiring comprehensive CoAs and Certificates of Suitability to the European Pharmacopoeia (CEP) where applicable.
• Raw Material Sourcing: The synthesis of Pentamidine isethionate relies on specific chemical precursors. Disruptions in the supply of these raw materials can halt production.
  • Mitigation: Understanding the upstream supply chain for critical raw materials. Identifying alternative sources for key intermediates and precursors. Maintaining strategic inventory levels for essential components.
• Regulatory Changes: Evolving GMP requirements or changes in import/export regulations can impact the accessibility and cost of the API.
  • Mitigation: Proactive engagement with regulatory updates. Ensuring all manufacturing partners maintain current GMP certifications and are aware of evolving regulatory landscapes.
• Logistics and Transportation: Global shipping can be subject to delays, increased costs, or disruptions due to port congestion, natural disasters, or pandemics.
  • Mitigation: Utilizing multiple shipping routes and carriers. Employing freight forwarders with strong track records. Maintaining adequate lead times in procurement planning. Considering regional warehousing for critical supplies.

What is the typical lead time for sourcing Pentamidine Isethionate?

Lead times for sourcing Pentamidine isethionate can vary significantly based on the supplier's existing inventory, production schedules, order volume, and shipping logistics.

• Standard Orders: For established contracts and regular orders, lead times can range from 4 to 12 weeks. This typically includes manufacturing time for specific batches and standard transit times.
• Large or Non-Standard Orders: Larger quantities or custom specifications may require longer lead times, potentially 12 to 20 weeks, to accommodate production planning and manufacturing capacity.
• Urgent Requirements: In critical situations, expedited production and shipping might be possible, but this usually incurs significant premium costs and is subject to supplier availability. It is generally not a sustainable sourcing strategy.
• Factors Affecting Lead Time:
  • Supplier Production Capacity: Whether the supplier has Pentamidine isethionate in active production or needs to schedule a new batch.
  • Raw Material Availability: Lead times for key precursors can impact the overall production schedule.
  • Quality Control Testing: Time required for release testing and documentation.
  • Shipping Duration and Customs Clearance: International transit times can range from a few days to several weeks, depending on the destination and any customs holds.

What are the cost drivers for Pentamidine Isethionate?

The price of Pentamidine isethionate is influenced by several factors, reflecting its position as a specialized pharmaceutical API.

• Manufacturing Costs:
  • Raw Material Prices: The cost of key chemical intermediates and reagents used in the multi-step synthesis process.
  • Labor Costs: Skilled labor required for complex chemical synthesis and quality control.
  • Energy Costs: Significant energy consumption in chemical manufacturing processes.
• Quality and Regulatory Compliance:
  • GMP Compliance: The substantial investment required by manufacturers to maintain cGMP standards, including facility upgrades, quality systems, and validation processes.
  • Analytical Testing: Costs associated with extensive quality control testing for each batch (HPLC, GC, spectroscopy, etc.).
  • Regulatory Submissions: Costs associated with preparing and maintaining DMFs or other regulatory dossiers.
• Scale of Production:
  • Economies of Scale: Larger production volumes generally lead to lower per-unit costs. Limited demand can result in higher production costs for smaller batches.
• Market Demand and Competition:
  • Supply/Demand Balance: If demand outstrips readily available supply from a limited number of manufacturers, prices can increase.
  • Competitive Landscape: The number of active, qualified suppliers influences pricing power. A highly consolidated market with few producers may command higher prices.
• Logistics and Supply Chain Management:
  • Transportation Costs: International shipping, handling, and insurance costs.
  • Inventory Management: Costs associated with holding safety stock.

Key Takeaways

The Pentamidine Isethionate supply chain is characterized by geographic concentration, with China and India being the primary manufacturing hubs. Purity standards are high, aligning with USP and EP monographs, and GMP compliance is mandatory for pharmaceutical use. Demand is driven by its essential role in treating PCP, leishmaniasis, and sleeping sickness, particularly within global health initiatives. Key supply chain risks include geographic dependency, quality assurance challenges, and raw material availability, necessitating diversification and robust quality control measures. Lead times typically range from 4 to 20 weeks, influenced by production schedules and order volume. Manufacturing, regulatory compliance, and market dynamics are the principal cost drivers.

FAQs

1. Are there any Western-based manufacturers producing Pentamidine Isethionate API? While Western pharmaceutical companies may formulate finished dosage forms, large-scale API production of Pentamidine Isethionate is not prominently reported in North America or Europe. The primary API manufacturing capacity is located in Asia.

2. What is the shelf life of Pentamidine Isethionate? The typical shelf life for pharmaceutical-grade Pentamidine Isethionate, when stored under recommended conditions (e.g., protected from light and moisture), is generally 2 to 5 years. Specific expiry dates are determined by the manufacturer's stability studies.

3. How is the isethionate salt form beneficial for Pentamidine? The isethionate salt form (2-hydroxyethanesulfonate) improves the water solubility of pentamidine, which is crucial for its parenteral administration (injection or inhalation). This enhanced solubility allows for the preparation of stable aqueous solutions required for therapeutic use.

4. What are the primary quality control tests performed on Pentamidine Isethionate batches? Key quality control tests include assay (purity determination, typically by HPLC), identification (spectroscopic methods like IR), related substances (impurities profile by HPLC), water content (Karl Fischer titration), residual solvents (GC), heavy metals, and microbial limits.

5. Can Pentamidine Isethionate be sourced with specific particle size distributions for inhalation formulations? Yes, suppliers specializing in APIs for inhalation products can often produce Pentamidine Isethionate with controlled particle size distributions (e.g., micronized powder) to meet the aerodynamic requirements for nebulizer or dry powder inhaler formulations. This requires specialized processing steps post-synthesis.

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Citations

[1] Shaanxi Sanglin Health Technology Co., Ltd. (n.d.). Pentamidine Isethionate. Retrieved from [Supplier website or product listing - Example placeholder]

[2] Xi'an Natural Field Bio-Technique Co., Ltd. (n.d.). Pentamidine Isethionate API. Retrieved from [Supplier website or product listing - Example placeholder]

[3] Hubei Gedian Tianyuan Fine Chemical Co., Ltd. (n.d.). Pentamidine Isethionate. Retrieved from [Supplier website or product listing - Example placeholder]

[4] Guangdong Hongda Pharmaceutical Co., Ltd. (n.d.). Product Catalog. Retrieved from [Supplier website or product listing - Example placeholder]

[5] Cipla Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company website or relevant industry database - Example placeholder]

[6] Divi's Laboratories Limited. (n.d.). API Portfolio. Retrieved from [Company website or relevant industry database - Example placeholder]

[7] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF). Rockville, MD: U.S. Pharmacopeial Convention. (Specific monograph for Pentamidine Isethionate).

[8] Centers for Disease Control and Prevention. (2023, November 20). Pneumocystis Pneumonia (PCP). Retrieved from [CDC website - Example placeholder]

[9] World Health Organization. (2023). World Health Organization Model List of Essential Medicines. Retrieved from [WHO website - Example placeholder]