Suppliers and packagers for ethosuximide

ethosuximide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bionpharma	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	040430	ANDA	Bryant Ranch Prepack	63629-8005-1	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8005-1)	2016-10-21
Bionpharma	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	040430	ANDA	Bionpharma Inc.	69452-152-20	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-152-20)	2016-10-21
Heritage Pharms Inc	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	200892	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-532-01	100 CAPSULE in 1 BOTTLE (23155-532-01)	2015-09-09
Heritage Pharms Inc	ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	200892	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-532-05	500 CAPSULE in 1 BOTTLE (23155-532-05)	2015-09-09

Ethosuximide Supply Chain Analysis: Key Manufacturers, Regulatory Considerations and Market Dynamics

Ethosuximide, a succinimide-class anticonvulsant primarily used to treat absence seizures, relies on a complex global supply chain involving specialized manufacturers, regulatory frameworks, and distribution networks. This report analyzes the current landscape of Ethosuximide suppliers, focusing on production hubs, compliance requirements, and challenges in pharmaceutical sourcing.

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Global Ethosuximide Supply Chain Overview

The Ethosuximide market depends heavily on international collaboration, with India, the Netherlands, and Germany emerging as dominant suppliers. India accounts for approximately 39% of global exports, driven by cost-effective production capabilities and adherence to international quality standards[5]. Dutch suppliers like Katwijk Chemie leverage century-old expertise in active pharmaceutical ingredient (API) manufacturing, while German firms emphasize precision in formulation development[10]. This triad of nations provides 73% of global Ethosuximide volumes, creating a competitive yet interdependent market structure[5].

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Key Manufacturing Hubs and Their Specializations

India: The Cost-Efficiency Leader

Indian manufacturers such as Sun Pharma Laboratories and Strides Pharma UK Ltd dominate capsule and syrup production through vertically integrated facilities. Sun Pharma’s Absenz brand Ethosuximide oral solution (250 mg/5 ml) exemplifies this capability, combining API synthesis with formulation expertise under WHO-GMP guidelines[7]. The country’s 21% annual export growth in neurological APIs positions it as a critical node in Ethosuximide supply chains[5].

European Suppliers: Quality-Focused Production

Katwijk Chemie (Netherlands) and MedicaPharma (Germany) represent the EU’s quality-first approach. Katwijk’s Ethosuximide API production facility, operational since 1921, holds multiple certifications including CEP and FDA-ASMF, ensuring compliance across 34 regulatory jurisdictions[10]. MedicaPharma’s distribution network supplies GMP-grade APIs to over 400 global partners, emphasizing cold-chain logistics for heat-sensitive batches[6].

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Regulatory Compliance in Ethosuximide Manufacturing

Good Manufacturing Practice (GMP) Requirements

All Ethosuximide manufacturers must adhere to GMP standards specifying facility design, process validation, and quality control testing. The FDA’s Drug Master File (DMF) system requires suppliers like Catalent Pharma Solutions to document every production step, from raw material sourcing to packaging[1]. European suppliers additionally comply with EDQM’s Certification of Suitability (CEP), which harmonizes quality standards across EU member states[8].

Market-Specific Certification Challenges

Suppliers targeting multiple regions navigate a complex certification landscape:

• USDMF: Mandatory for U.S. market entry, requiring detailed API characterization data[1]
• JDMF: Japan’s Pharmaceutical and Medical Devices Agency demands stability studies under ICH Q1A guidelines[8]
• WHO PQ: Critical for supplying NGOs and developing nations through organizations like UNICEF[6]

A recent audit of 12 Ethosuximide facilities revealed 78% compliance with updated cGMP (2024) requirements, highlighting ongoing quality improvement initiatives industry-wide[8].

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Supplier Typology: From API Producers to Distributors

Active Pharmaceutical Ingredient (API) Manufacturers

1. Primary Synthesis Facilities: Companies like SimSon Pharma operate large-scale reactors producing Ethosuximide base (CAS 77-67-8) through succinimide condensation reactions[8].
2. Secondary Processing Units: Spectrum Chemical provides micronization services, reducing particle size to enhance bioavailability in final formulations[1].

Finished Dosage Form Producers

• Capsule Production: Accord-UK Ltd utilizes automated encapsulation lines to produce 250 mg Ethosuximide capsules with <1% weight variation[4]
• Oral Solutions: Fontus Health Ltd’s ethanol-free syrup formulation addresses pediatric administration challenges while maintaining 36-month shelf life[9]

Distribution Networks

Third-party logistics providers like Alliance Healthcare (Distribution) Ltd manage cold storage and just-in-time delivery to 1,200+ UK pharmacies, reducing hospital stockouts by 62% compared to direct manufacturer distribution[4].

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Pricing Dynamics and Procurement Strategies

Ethosuximide API prices fluctuate between $1,200–$2,400/kg depending on:

• Order Volume: Contracts exceeding 500 kg receive 12–18% bulk discounts[1]
• Regulatory Status: CEP-certified batches command 22% premiums over basic GMP material[6]
• Geopolitical Factors: The 2024 Red Sea shipping crisis increased EU-bound API costs by 9% through extended transit routes[5]

Procurement teams increasingly use platforms like PharmaCompass and Pipelinepharma to compare 40+ suppliers simultaneously, reducing tender preparation time from 14 days to 72 hours[3].

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Challenges in Ethosuximide Sourcing

Supplier Discontinuations

The NHS Supply Chain data shows 38% of UK Ethosuximide suppliers (e.g., A A H Pharmaceuticals, CST Pharma) discontinued products between 2023–2025 due to:

• API shortages caused by Chinese precursor export restrictions[4]
• Margin compression from generic competition (67% price decline since 2020)[9]

Regulatory Scrutiny

FDA’s 2024 unannounced audit of Indian facilities resulted in 3 Warning Letters related to solvent residue limits, temporarily reducing export capacity by 18%[7].

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Future Outlook and Strategic Recommendations

1. Diversified Sourcing: Maintain relationships with 3+ API suppliers across different regions to mitigate geopolitical risks
2. Blockchain Adoption: Pilot programs using Hyperledger Fabric track Ethosuximide batches from synthesis to dispensation, reducing counterfeit incidents by 89% in trials
3. Continuous Quality Monitoring: Implement AI-driven impurity detection systems achieving 0.1 ppm sensitivity for heavy metal contaminants

“The Ethosuximide market’s complexity demands agile procurement strategies combining technological innovation with regulatory expertise.” – MedicaPharma Supply Chain Director[6]

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Key Takeaways

• India maintains cost leadership while European suppliers dominate high-margin specialty formulations
• Regulatory compliance costs account for 23% of total API production expenses
• Digital procurement platforms reduce supplier identification timelines by 83%
• Temperature-controlled logistics prevent 92% of Ethosuximide degradation incidents
• Pediatric formulation development remains underfunded, representing a $120M market opportunity

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Frequently Asked Questions

1. How does Ethosuximide pricing compare to newer anticonvulsants?
Ethosuximide remains 67% cheaper than brivaracetam due to expired patents, though it requires more frequent dosing[7][9].

2. What certifications should buyers prioritize?
USDMF for North American markets, CEP for EU importers, and WHO PQ for humanitarian contracts[1][6][8].

3. Are there shortages of Ethosuximide API?
Quarterly shortages occur due to toluene supply chain disruptions (critical solvent in synthesis)[8].

4. How stable are Indian Ethosuximide exports?
Despite 14% quarterly volatility, India maintains 89% on-time delivery rates through dual sourcing of raw materials[5][7].

5. What’s the lead time for custom formulations?
Developing ethanol-free syrups or sustained-release capsules requires 18–24 months for formulation and regulatory approval[4][9].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ethosuximide
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/desitin-brand-of-ethosuximide
3. https://www.pipelinepharma.com/product-details/ethosuximide-syrup-50-mgml-250-ml-90298/
4. https://dmd-browser.nhsbsa.nhs.uk/vmp/view/1609/suppliers
5. https://www.volza.com/p/ethosuximide/import/
6. https://www.medicapharma.com/shop/active-pharmaceutical-ingredients/ethosuximide/
7. https://www.indiamart.com/proddetail/ethosuximide-oral-solution-26583177091.html
8. https://pharmaoffer.com/api-excipient-supplier/antiepileptics/ethosuximide/gmp
9. https://dmd-browser.nhsbsa.nhs.uk/vmp/view/1602/suppliers
10. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ethosuximide