Bulk Pharmaceutical API Sources for DILANTIN

Bulk Pharmaceutical API Sources for DILANTIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D4007_SIGMA
Vitas-M Laboratory		STK058029
Vitas-M Laboratory		STK182871
TCI (Tokyo Chemical Industry)		D0894
Molport		MolPort-001-785-683
Molport		MolPort-002-365-712
Hangzhou APIChem Technology		AC-376

Bulk Active Pharmaceutical Ingredient (API) Sources for DILANTIN

Last updated: July 28, 2025

Introduction

DILANTIN, the brand name for phenytoin, is a well-established antiepileptic drug primarily used to control seizures. As a critical pharmaceutical component, the quality and reliability of its Active Pharmaceutical Ingredient (API) procurement are vital for manufacturers and healthcare providers to ensure safety, efficacy, and uninterrupted supply. The global API supply chain for phenytoin is complex, involving numerous manufacturers and suppliers across various regions, each with differing compliance standards, pricing structures, and production capacities. This article provides a comprehensive overview of reliable bulk API sources for DILANTIN, facilitating informed purchasing decisions for pharmaceutical companies and stakeholders.

Phenytoin API Overview

Phenytoin (C15H12N2NaO2) is characterized by its narrow therapeutic window, making the purity and consistency of the API paramount. It is primarily produced through chemical synthesis, with key specifications including potency, impurity profiles, and residual solvents aligned with pharmacopeial standards such as USP, EP, or JP monographs. The major suppliers focus on maintaining stringent quality management systems, adherence to Good Manufacturing Practices (GMP), and comprehensive documentation.

Leading Global API Suppliers for DILANTIN

1. United States and North America

a. Teva Pharmaceuticals
One of the largest generic drug manufacturers globally, Teva supplies high-quality phenytoin APIs. Their manufacturing facilities, compliant with US FDA standards, ensure robust quality and supply chain security. Teva's API manufacturing process adheres to GMP, with rigorous quality controls suitable for critical drugs like DILANTIN.

b. North American Specialty API Suppliers
Other notable North American API producers include Par Pharmaceutical and LGM Pharma, offering customized API sourcing options. These companies often provide both bulk API and contractual manufacturing, prioritizing quality assurance and regulatory compliance.

2. Europe

a. Evonik Industries
A leading European chemical and pharmaceutical ingredient producer, Evonik supplies high-purity phenytoin API. Their production facilities are certified under GMP and comply with EU regulations, ensuring consistent quality suitable for manufacturing DILANTIN.

b. Croda International
Croda supplies pharmaceutical-grade APIs and excipients, including phenytoin, with an emphasis on sustainability and high standards. Their European operations follow rigorous quality control measures, making them a reliable API source.

3. China

a. Zhejiang NHU Co., Ltd.
Zhejiang NHU stands as a prominent Chinese API manufacturer, offering cost-effective bulk phenytoin APIs. They have achieved GMP certification and are increasingly aligning with international standards to serve global markets.

b. Jiangsu Hengrui Medicine Co., Ltd.
Hengrui has gained recognition for its high-quality pharmaceutical ingredients, including phenytoin. Their API manufacturing facilities meet GMP and ISO certifications, supporting exports to Western markets.

4. India

a. Dr. Reddy's Laboratories
A significant Indian pharmaceutical exporter, Dr. Reddy’s produces API with stringent quality standards, including GMP compliance. Their phenytoin API offers USP-grade specifications suitable for global distribution.

b. Aurobindo Pharma
Aurobindo maintains a robust API manufacturing portfolio, including phenytoin, reputed for quality consistency and cost competitiveness, with manufacturing facilities compliant with international standards.

5. Other Notable Suppliers

• Hikvision Pharma (South Korea): Noted for high-quality APIs, including rare formulations.
• Synthesis and Contract Manufacturing Specialists: Many specialty API producers offer custom synthesis and large-scale supply for phenytoin under contractual agreements, serving niche or high-volume requirements.

Key Considerations in API Sourcing for DILANTIN

Quality and Regulatory Compliance

Qualities such as assay, impurity profiles, residual solvents, and heavy metals are critical. Suppliers must provide comprehensive Certificates of Analysis (CoA), stability data, and evidence of compliance with international pharmacopeias. Validation of manufacturing facilities under GMP is non-negotiable for pharmaceutical-grade API.

Supply Chain Security

Disruptions can severely impact manufacturing continuity. Diversifying suppliers across regions, verifying certifications, and establishing long-term relationships mitigate risks associated with geopolitical, logistical, or regulatory challenges.

Pricing and Contract Terms

While cost optimization is essential, quality should not be compromised. Long-term agreements often include clauses for batch consistency, technical support, and contingency provisions in case of supply interruptions.

Environmental and Ethical Standards

Sustainable practices and adherence to environmental regulations are increasingly influencing supplier selection. Transparent environmental management systems add value and reduce compliance risks.

Emerging Trends in API Supply for DILANTIN

• GMP Certification Consolidation: Upward trend towards global GMP standards ensures API quality consistency.
• Regional Production Scalability: Asian manufacturers, particularly Chinese and Indian suppliers, are expanding capacities to meet global demand while maintaining competitive prices.
• Regulatory Recognition: Suppliers with approvals from major regulatory bodies (FDA, EMA, PMDA) are preferred for high-stakes pharmaceuticals like DILANTIN.
• Supply Chain Digitization: Traceability systems and digital documentation improve transparency and mitigate counterfeit risks.

Conclusion

The landscape of bulk API sourcing for DILANTIN is multifaceted, involving geographically diverse suppliers, stringent quality standards, and dynamic regulatory environments. Major suppliers from North America, Europe, China, and India are equipped to meet the pharmaceutical industry's high standards. Selecting the right source hinges on evaluating quality certifications, supply reliability, cost, and compliance. Establishing robust supplier relationships and comprehensive due diligence are essential strategies to ensure consistent, high-quality API procurement for DILANTIN manufacturing.

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Key Takeaways

• Ensure API suppliers possess comprehensive GMP and regulatory certifications aligning with major pharmacopeias.
• Diversify sourcing to mitigate risks related to geopolitical or supply chain disruptions.
• Prioritize quality assurance through rigorous documentation, impurity profiling, and stability data.
• Consider regional suppliers for cost efficiency, but verify regulatory approvals and compliance standards.
• Stay informed about emerging trends like digital traceability and environmentally sustainable practices.

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FAQs

Q1: What are the primary factors to consider when sourcing API for DILANTIN?
A: Quality compliance (GMP certification, pharmacopeial standards), supply reliability, pricing, regulatory approvals, environmental practices, and supplier reputation.

Q2: Which regions dominate the manufacturing of phenytoin API?
A: Key regions include North America (US), Europe, China, and India, with enhanced capacities and strict regulatory oversight in established markets.

Q3: How does supplier certification impact API quality for DILANTIN?
A: Certification such as GMP ensures the supplier meets stringent manufacturing and quality control standards, reducing risks of impurities and batch variability.

Q4: Are Chinese and Indian API suppliers suitable for pharmaceutical-grade DILANTIN production?
A: Yes, many Chinese and Indian suppliers have achieved GMP and international certification, making them suitable when quality and compliance are thoroughly verified.

Q5: What is the importance of supply chain diversification for API sourcing?
A: Diversification minimizes risks from geopolitical tensions, logistical issues, and regulatory changes, ensuring uninterrupted production.

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References

[1] U.S. Pharmacopeia (USP). "Phenytoin Monograph." USP, 2022.
[2] European Pharmacopoeia (EP). "Phenytoin." EP, 2022.
[3] IQVIA. "Global API Market Trends and Suppliers," 2022.
[4] FDA 21 CFR Part 211. "Current Good Manufacturing Practice for Finished Pharmaceuticals," 2023.
[5] WHO. "Guidelines on Good Manufacturing Practices," 2022.