Suppliers and packagers for generic pharmaceutical drug: ECHOTHIOPHATE IODIDE

ECHOTHIOPHATE IODIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963	NDA	Fera Pharmaceuticals, LLC	48102-053-05	1 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05)	2022-06-01

Last updated: August 1, 2025

ppliers for the Pharmaceutical Drug: ECHOTHIOPHATE IODIDE

Introduction
Echothiophate iodide is a longstanding cholinesterase-inhibiting agent primarily used in ophthalmology to treat glaucoma through prolonged miosis and reduction of intraocular pressure. As a critical component in the management of ocular hypertension, its supply chain involves specialized manufacturers with longstanding expertise in producing quaternary ammonium compounds and cholinesterase inhibitors. This analysis delineates key suppliers globally, examines market dynamics, regulatory considerations, and the factors influencing sourcing decisions for echothiophate iodide.

Overview of Echothiophate Iodide
Echothiophate iodide is a potent, long-acting organophosphate compound. Its synthesis involves organophosphorus chemistry, requiring specialized knowledge and facilities. The drug's production is tightly regulated, considering its classification as a cholinesterase inhibitor with potential neurotoxicity if mishandled. Consequently, the supplier landscape is concentrated among a few firms with rigorous quality assurance protocols aligned with regulatory standards such as FDA, EMA, and other regional authorities.

Global Suppliers of Echothiophate Iodide

1. Pharmaceutical Manufacturers with Established Production Capabilities

Many existing suppliers of echothiophate iodide are legacy manufacturers primarily servicing ophthalmic markets in North America, Europe, and Asia. They often operate under strict licensing arrangements due to the drug’s controlled substance status and safety concerns.

Alaun Healthcare

• Overview: Based in India, Alaun Healthcare is recognized as one of the leading suppliers of ophthalmic pharmaceuticals, including echothiophate iodide.
• Capabilities: Provides bulk API (Active Pharmaceutical Ingredient) to pharmaceutical companies and compounding pharmacies globally.
• Regulatory Status: Complies with WHO GMP standards, facilitating export to various regions.

CordenPharma (Part of the Stability Group)

• Overview: CordenPharma specializes in active pharmaceutical ingredients, including niche organophosphates.
• Capabilities: Offers custom synthesis and high-purity APIs for ophthalmic formulations.
• Regulatory Compliance: Follows strict international standards, including USFDA and EMA cGMP protocols.

Sandoz (Novartis Division)

• Overview: Historically, Novartis produced echothiophate iodide during its earlier pharmaceutical operations.
• Sourcing and Supply: While Novartis has largely phased out the drug commercially, the company's legacy manufacturing plants are potential sources of APIs or licensing opportunities for qualified producers.

2. Contract Manufacturing and Export Specialists

Given the specialized synthesis process, many pharmaceutical companies opt to contract manufacturing to experienced biotech organizations.

EuroAPI

• Capabilities: Provides custom synthesis of organophosphates and cholinesterase inhibitors.
• Market Position: Serves both generic and branded sectors with high-quality, compliant APIs.

Synthesis Solutions

• Focus: Offers contract synthesis of niche organophosphates, including echothiophate analogs.
• Regulatory Profile: Adheres to multiple regional standards, supporting global supply chains.

3. Regional Variations and Emerging Suppliers

• China and India remain dominant in global API manufacturing, with numerous small and medium-sized enterprises (SMEs) capable of producing echothiophate iodide.
• China: Companies like Zhejiang Medicine Co., Ltd. and North China Pharmaceutical Group Corporation have reported capabilities in organophosphates but are typically involved in intermediates rather than final APIs.
• India: Several local manufacturers, such as Micro Labs and Aarti Drugs, produce ophthalmic APIs, potentially including echothiophate iodide through licensed or covert manufacturing arrangements.

Regulatory and Quality Considerations
The supply chain for echothiophate iodide is highly regulated owing to its classification as an alkylphosphorus compound with neuroactive properties. Suppliers must comply with stringent cGMP standards, environmental regulations, and safety protocols. USFDA- and EMA-approved manufacturing facilities are preferred sources to mitigate regulatory risks in global markets.

Market Dynamics and Challenges

• Supply Tightness: The niche nature of echothiophate iodide results in a limited number of manufacturers. Any disruption, such as regulatory non-compliance or manufacturing issues, can lead to shortages.
• Regulatory Hurdles: Ongoing regulatory scrutiny around safety concerns associated with organophosphates influences supplier operations and market availability.
• Market Shifts: The declining popularity of echothiophate iodide, driven by newer therapies, impacts investment in manufacturing capacity, risking supply stability.

Emerging Trends and Future Outlook

• Alternative Therapies: The advent of prostaglandin analogs and laser surgeries is decreasing demand, possibly leading to production discontinuations.
• Generic Market Entry: Some generic manufacturers may seek to produce echothiophate iodide, but high regulatory barriers and niche demand mean offerings remain limited.
• Supply Chain Consolidation: Major pharmaceutical firms may seek strategic partnerships or licensing agreements for stable sourcing.

Key Sourcing Strategies

• Establish relationships with GMP-compliant manufacturers specializing in organophosphates.
• Ensure rigorous qualification processes, including technical audits and regulatory verifications.
• Monitor market shifts towards alternative glaucoma treatments to adjust procurement strategies proactively.

Key Takeaways

• Limited Supplier Pool: The market for echothiophate iodide features a small group of reputable suppliers, primarily in India, Europe, and the US, with high regulatory compliance standards.
• Regulatory Dependence: Strict adherence to cGMP and safety standards is essential, influencing supplier reliability and product quality.
• Market Volatility: Changes in ophthalmic treatment preferences could reduce demand, affecting supply stability and investment in manufacturing capacity.
• Supply Chain Resilience: Securing supply requires diversified sourcing strategies and careful supplier qualification.
• Future Considerations: Alternatives to echothiophate iodide may further constrain the market, necessitating continuous supplier assessment and contingency planning.

FAQs

1. Who are the main global suppliers of echothiophate iodide?
Primarily, Alaun Healthcare (India), CordenPharma (Europe), and legacy producers like Novartis (US/Europe) serve as key sources, with numerous regional manufacturers in China and India capable of production under licensing or custom synthesis agreements.

2. What regulatory standards should suppliers meet?
Suppliers must comply with cGMP standards mandated by authorities such as the USFDA, EMA, or equivalent, ensuring API purity, safety, and traceability for ophthalmic use.

3. Are there any recent disruptions in echothiophate iodide supply?
Supply disruptions are infrequent but possible due to regulatory hurdles, manufacturing issues, or market decline driven by alternative glaucoma therapies. Tracking regulatory updates and supplier capacity is essential.

4. How does market demand affect sourcing strategies?
Declining demand for echothiophate iodide impacts manufacturing focus; companies should monitor treatment trends and maintain flexible sourcing arrangements to mitigate shortages.

5. Can I procure echothiophate iodide directly from API manufacturers?
Procurement typically involves establishing partnerships or contracts with qualified API producers, given the drug's controlled status, complex synthesis, and regional regulatory requirements.

Conclusion
The supply landscape for echothiophate iodide remains concentrated within a handful of specialized manufacturers equipped to meet stringent regulatory standards. For pharmaceutical companies and healthcare providers, understanding supplier capabilities, regulatory compliance, and market dynamics is vital for ensuring uninterrupted access. As the demand for ophthalmic treatments evolves, strategic sourcing and proactive supply chain management will be critical to maintaining operational resilience.

References
[1] U.S. Food and Drug Administration (FDA). Drug Approved Supplements and Listings.
[2] European Medicines Agency (EMA). Community Register of Medicines.
[3] Pharmaceutical Technology. Niche Ophthalmic APIs: Market Trends and Sourcing.
[4] Synthesis and Manufacturing Reports. Organophosphate APIs.
[5] Industry Reports on Ophthalmic Drug Market and Supply Chain Dynamics.