Bulk Pharmaceutical API Sources for trimethadione

Bulk Pharmaceutical API Sources for trimethadione

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HeVL@LAIRYYdjZji`@@
NovoSeek		5576
MolPort		MolPort-001-846-840
ABI Chem		AC1L1KNK
ABI Chem		AC1Q3XZF
AKos Consulting & Solutions		AKOS006229172

Bulk Active Pharmaceutical Ingredient (API) Sources for: Trimethadione

Last updated: July 27, 2025

Introduction

Trimethadione (TMO), a classical antiepileptic drug, was historically used to manage certain seizure types, notably partial seizures with or without secondary generalization. Although its clinical use has declined due to the advent of newer therapeutics, it remains available in specific regions and for rare indications. Given its pharmacological importance, sourcing high-quality bulk API is critical for manufacturers, compounding pharmacies, and regulatory bodies. This article offers an in-depth review of sources for bulk trimethadione API, evaluating key suppliers, manufacturing considerations, regulatory status, and supply chain dynamics within the pharmaceutical industry.

Background on Trimethadione API

Trimethadione is a trioxo derivative of oxazolidine with the chemical formula C_6H_10N_2O_3. It is classified as a class 2 controlled substance in certain regions due to its sedative and anticonvulsant properties. The synthesis of trimethadione involves the condensation of acetamide with malonic acid derivatives, followed by cyclization and oxidation steps. Due to its complex synthesis and strict regulatory oversight, sourcing genuine, high-quality API presents specific challenges.

Global API Manufacturing Landscape

The global API manufacturing landscape for trimethadione is characterized by a limited number of suppliers with the capability to produce complex, controlled APIs under Good Manufacturing Practices (GMP). Since the drug's medical use has waned in many markets, especially the U.S. and EU, manufacturing activity for trimethadione APIs has decreased proportionally, leading to a scarcity of readily available suppliers.

Major Regions and Their Role

• India: Recognized for its robust API manufacturing sector, India historically produced a significant share of classical antiepileptics, including trimethadione. Companies such as Divis Laboratories and Sri Krishna Pharma have supplied APIs to global markets, although current production levels for trimethadione are limited.

• China: As a major API producer, China hosts multiple facilities capable of synthesizing advanced intermediates and APIs. However, due to stringent regulatory controls and the niche status of trimethadione, dedicated Chinese suppliers are scarce.

• Eastern Europe and Latin America: Limited domestic production; mostly reliant on imports from India or China.

• United States and Western Europe: Minimal to no local production of trimethadione API owing to market withdrawal and regulatory restrictions.

Key API Suppliers and Distributors

1. Divis Laboratories (India)

• Product Range: Known for cardiovascular, antiepileptic, and CNS APIs, Divis Laboratories maintains GMP-certified facilities capable of producing trimethadione.
• Availability: While historically a supplier, current demand and market status suggest limited stock. Manufacturers are advised to contact Divis directly for availability and batch certifications.
• Regulatory Status: Compliant with US FDA and EMA standards, ensuring quality and traceability.

2. Sri Krishna Pharma (India)

• Product Range: Offers a range of controlled substances and APIs, including older antiepileptics.
• Supply Capacity: Capable of manufacturing custom synthesis to meet specific purity requirements.
• Certification: GMP-certified with export licenses for regulated markets.

3. Other Indian Manufacturers

• Several smaller firms and contract manufacturing organizations (CMOs) claim to produce trimethadione API, often under custom synthesis arrangements.
• At present, due diligence is vital to verify regulatory compliance and quality assurance records.

4. Chinese Manufacturers

• Few Chinese firms explicitly advertise trimethadione API; most focus on intermediates rather than finished APIs.
• Importing from China requires scrutinized due diligence regarding regulatory compliance, GMP certification, and export legitimacy.

5. Specialized API Brokers and Distributors

• Several pharmaceutical supply chain brokers facilitate the procurement of rare APIs, including trimethadione, primarily sourcing from India or China.
• Caveat: Buyers must verify supplier credentials, GMP compliance, and batch documentation to mitigate risks associated with counterfeit or substandard products.

Regulatory Considerations for API Sourcing

Due to its controlled substance classification, sourcing trimethadione API involves navigating complex regulatory landscapes:

• Controlled Substance Regulations: Manufacturers in the U.S. and EU must comply with Drug Enforcement Agency (DEA) or equivalent bodies' licensing requirements.
• Import and Export Licenses: Necessary for cross-border transportation, especially for controlled substances.
• Quality Assurance: GMP certification, batch records, and analytical data must accompany the API to ensure consistency, potency, and purity.
• Inspection and Certification: Regulatory audits (e.g., FDA, EMA) can impact the ability to procure or import API.

Supply Chain Challenges

• Market Decline: Reduced demand has led to lower production volumes, increasing procurement costs and lead times.
• GMP Compliance: Few suppliers maintain current GMP certifications for trimethadione, raising quality concerns.
• Regulatory Variability: Different jurisdictions impose diverse restrictions, complicating global procurement.
• Counterfeit Risks: Scarcity and high demand may elevate risks of substandard or counterfeit APIs infiltrating the supply chain.

Future Outlook

While demand for trimethadione has waned, specialized applications, research, or legacy pharmacy compounding sustain a niche market. The limited manufacturing landscape and regulatory complexities suggest that sourcing high-quality API will remain challenging. Manufacturers must engage closely with reliable suppliers, verify certifications meticulously, and consider alternative treatments aligned with current clinical standards.

Conclusion

The bulk sourcing landscape for trimethadione API is characterized by a handful of reputable suppliers, predominantly based in India. Global supply remains constrained by regulatory controls, decreasing market demand, and manufacturing limitations. Enterprises seeking to obtain this API should prioritize suppliers with transparent GMP compliance, regulatory licensing, and verified quality assurance measures. Strategic procurement, coupled with due diligence, is critical to mitigate risks associated with sourcing this niche but vital pharmaceutical ingredient.

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Key Takeaways

• Limited Suppliers: Predominantly located in India, with few options from China, due to the niche status and regulatory restrictions.
• Regulatory Compliance: Ensure suppliers hold current GMP certifications and appropriate licenses for controlled substances.
• Supply Chain Risks: Scarcity and regulatory hurdles increase procurement complexity; early engagement and verification are vital.
• Quality Assurance: Rigorous testing, documentation, and adherence to international standards safeguard product integrity.
• Market Dynamics: Declining demand influences supply availability; consider alternative therapies and formulations where feasible.

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FAQs

1. Is trimethadione API still commercially available?
Availability is limited; certain Indian GMP-certified suppliers may provide it, but supply scarcity and regulatory restrictions pose significant challenges.

2. What are the primary regions for sourcing trimethadione API?
India remains the main global supplier, with some potential sources in China; however, supply chains are scarce due to decreased demand.

3. What regulatory hurdles exist in importing trimethadione API?
Strict control laws govern its import/export as a controlled substance, necessitating licenses, compliance documentation, and adherence to regional regulations.

4. Can I verify the quality of trimethadione API from a supplier?
Yes, request Certificates of Analysis (CoA), GMP certification, and regulatory documentation to confirm API quality and compliance.

5. Are there alternatives to trimethadione for epilepsy management?
Yes, newer antiepileptics like valproic acid, lamotrigine, and levetiracetam are preferred due to better safety profiles and wider approval.

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References
[1] Pharmaceutical supplier directories and industry reports (as applicable).
[2] Regulatory agency guidelines on controlled substances (FDA, EMA).
[3] Market analyses on pharmaceutical API manufacturing trends.