Bulk Pharmaceutical API Sources for PHENOBARBITAL SODIUM

Bulk Pharmaceutical API Sources for PHENOBARBITAL SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P5178_SIGMA
Hangzhou APIChem Technology		AC-11674
AAA Chemistry		AR-1L4933
ABI Chem		AC1Q1VYT
TCI (Tokyo Chemical Industry)		P0890
ChemMol		30101541

Phenobarbital Sodium API Sourcing Analysis

Last updated: February 19, 2026

Executive Summary

This report analyzes the landscape of bulk active pharmaceutical ingredient (API) suppliers for phenobarbital sodium. The market exhibits a concentrated supply chain, with a significant portion of production originating in Asia, particularly China and India. Key considerations for procurement include regulatory compliance, quality control, price volatility, and supply chain resilience. Established manufacturers with strong regulatory track records and robust quality management systems are preferred for consistent, high-quality sourcing.

Global Phenobarbital Sodium API Manufacturing Landscape

The production of phenobarbital sodium API is dominated by a limited number of manufacturers, primarily located in Asia. This concentration presents both opportunities for competitive pricing and risks related to supply chain disruption.

Key Manufacturing Regions

• China: Holds the largest share of global phenobarbital sodium API production. Manufacturers in this region often offer competitive pricing but require diligent supplier qualification regarding quality and regulatory adherence.
• India: A significant producer with a growing number of manufacturers focused on export markets. Indian API suppliers are generally well-versed in international regulatory requirements, including US FDA and EMA standards.
• Europe: A smaller, but important, segment of production exists in Europe, often associated with established pharmaceutical companies. These suppliers typically offer premium quality and strong regulatory compliance, often at a higher price point.
• North America: Limited domestic production of phenobarbital sodium API exists. Sourcing from North America is less common for bulk API compared to finished dosage forms.

Supplier Profile Considerations

When evaluating phenobarbital sodium API suppliers, the following factors are critical:

• Regulatory Compliance: Evidence of adherence to Good Manufacturing Practices (GMP). For US markets, FDA facility inspections and Drug Master Files (DMFs) are essential. For European markets, Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) or EDQM audits are crucial.
• Quality Management Systems (QMS): Robust internal QMS, including detailed batch records, deviation management, change control, and CAPA (Corrective and Preventive Actions) systems.
• Production Capacity and Lead Times: Ability to meet projected demand volumes and reliable delivery schedules.
• Price: Cost per kilogram, factoring in all associated shipping, import duties, and quality assurance expenses.
• Supply Chain Transparency and Traceability: Clear understanding of the origin of raw materials and intermediate products.
• Auditing Capabilities: Willingness and ability to undergo third-party audits by potential customers.

Major Phenobarbital Sodium API Suppliers

The following table provides a preliminary overview of known bulk phenobarbital sodium API suppliers. It is imperative to conduct thorough due diligence on any potential supplier.

Company Name	Country of Origin	Primary Market Focus	Regulatory Filings/Certifications (Examples)	Notes
Zhejiang Huahai Pharmaceutical Co., Ltd.	China	Global	US DMF, CEP	Large-scale producer with a broad API portfolio. Known for stringent quality control and regulatory expertise.
Cipla Limited	India	Global	US DMF, EU GMP	A leading Indian pharmaceutical company with significant API manufacturing capabilities. Strong focus on generics and established regulatory pathways.
Dr. Reddy's Laboratories Ltd.	India	Global	US DMF, EDQM Certification	Another major Indian player with diversified API offerings. Invests heavily in R&D and compliance.
Sun Pharmaceutical Industries Ltd.	India	Global	US DMF, EU GMP	India's largest pharmaceutical company by market capitalization. Extensive API manufacturing footprint.
BASF SE (Pharmaceuticals division)	Germany	Global	EDQM Certification, US DMF	While BASF has a broad chemical portfolio, their pharmaceutical division is a potential source for high-quality APIs with strong European regulatory backing. Specific phenobarbital sodium production requires verification.
Novartis AG (API Manufacturing)	Switzerland	Global	EU GMP	Large multinational with internal API production for some products. Sourcing phenobarbital sodium from internal manufacturing is product-specific and often complex to access for external parties.

Note: This list is not exhaustive. The status of regulatory filings and specific product availability can change. Direct engagement with manufacturers is required for current information.

Phenobarbital Sodium API Specifications and Quality Control

Ensuring the quality of phenobarbital sodium API is paramount for patient safety and regulatory compliance. Key specifications are defined by pharmacopoeial standards.

Pharmacopoeial Standards

Phenobarbital sodium API must comply with relevant pharmacopoeias, most notably:

• United States Pharmacopeia (USP): Defines tests for identification, assay, related substances, residual solvents, and heavy metals. The USP monograph for Phenobarbital Sodium is critical.
• European Pharmacopoeia (Ph. Eur.): Similar to USP, the Ph. Eur. monograph sets standards for quality, purity, and identity.
• Japanese Pharmacopoeia (JP): Another recognized standard, particularly relevant for products targeting the Japanese market.

Critical Quality Attributes (CQAs)

• Assay: Typically 98.5% to 101.0% of phenobarbital sodium on the dried basis.
• Identification: Confirmatory tests using Infrared (IR) spectroscopy and chemical reactions.
• Related Substances: Strict limits on impurities, including phenobarbital, other barbiturates, and process-related impurities. Impurity profiling is a critical aspect of quality control.
• Loss on Drying: Limits residual moisture content.
• Residue on Ignition: Measures inorganic impurities.
• Heavy Metals: Limits on the presence of toxic heavy metals.
• Residual Solvents: Compliance with ICH Q3C guidelines for solvents used in manufacturing.

Supplier Quality Agreements (SQAs)

Establishing a robust Supplier Quality Agreement is a non-negotiable requirement. This legally binding document outlines the responsibilities of both the API manufacturer and the drug product manufacturer, covering:

• Quality specifications and testing methods.
• Change control procedures.
• Deviation and CAPA management.
• Complaint handling and product recall procedures.
• Audit rights.
• Confidentiality and data integrity.
• Ownership of batch records and analytical data.

Regulatory and Compliance Pathways

Navigating the regulatory landscape is crucial for sourcing phenobarbital sodium API.

United States

• Drug Master File (DMF): A submission to the FDA containing detailed information about the facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of the API. Customers can reference the DMF in their drug product applications (ANDA, NDA).
• FDA Inspections: Facilities supplying to the US market must be subject to FDA inspection and be in compliance with current GMP (cGMP).
• ANDA/NDA Submissions: The drug product manufacturer's Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) will list the API supplier and reference its DMF.

European Union

• Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP): Issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). A CEP demonstrates that the quality of the API is controlled by the relevant Ph. Eur. monograph.
• EU GMP Certification: Manufacturers must hold valid EU GMP certificates issued by a competent authority.
• Marketing Authorisation Application (MAA): The drug product manufacturer's MAA will require details about the API source, often including a CEP or an Active Substance Master File (ASMF).

Other Key Markets

• Other National Regulatory Agencies: Manufacturers targeting specific countries must comply with the respective national regulations (e.g., Health Canada, TGA in Australia, PMDA in Japan).

Pricing and Market Dynamics

The pricing of phenobarbital sodium API is influenced by several factors:

• Raw Material Costs: The cost of precursors for phenobarbital synthesis.
• Manufacturing Scale: Larger production volumes generally lead to lower per-unit costs.
• Regulatory Compliance Costs: Investments in GMP infrastructure, quality systems, and regulatory filings add to the overall cost.
• Geopolitical Factors: Trade policies, tariffs, and currency fluctuations can impact landed costs.
• Market Demand: Fluctuations in demand for finished phenobarbital sodium products.
• Supplier Competition: The number of qualified suppliers in the market.

Current market intelligence suggests that while prices can fluctuate, manufacturers in China and India generally offer the most competitive pricing. European suppliers typically command a premium due to higher manufacturing and compliance overheads. It is advisable to obtain multiple quotes and conduct thorough total cost of ownership analyses that include quality and regulatory assurance.

Supply Chain Risk Management

Given the concentrated nature of phenobarbital sodium API manufacturing, robust supply chain risk management is essential.

Strategies for Mitigation

• Dual Sourcing: Qualifying and maintaining relationships with at least two approved API suppliers, ideally from different geographic regions, to mitigate single-point-of-failure risks.
• Inventory Management: Maintaining adequate safety stock levels of API to buffer against unexpected supply disruptions.
• Supplier Audits: Regularly auditing key suppliers to ensure ongoing compliance with GMP and quality agreements.
• Contractual Safeguards: Including clauses in supply agreements that address force majeure events, business continuity plans, and intellectual property protection.
• Geographic Diversification: Whenever possible, sourcing from suppliers located in different regulatory jurisdictions and political environments.
• Monitoring Regulatory Changes: Staying abreast of evolving regulatory requirements in all target markets.

Key Takeaways

• The global supply of phenobarbital sodium API is concentrated, primarily in China and India.
• Rigorous supplier qualification, focusing on regulatory compliance (FDA, EMA), quality management systems, and consistent quality, is critical.
• Pharmacopoeial compliance (USP, Ph. Eur.) is a baseline requirement for API quality.
• Robust Supplier Quality Agreements and ongoing supplier audits are essential for risk mitigation.
• Supply chain resilience can be enhanced through dual sourcing and strategic inventory management.
• Pricing is dynamic and influenced by raw material costs, regulatory overhead, and market competition.

Frequently Asked Questions

1. What are the primary quality standards for phenobarbital sodium API? Phenobarbital sodium API must meet the standards set forth in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and potentially the Japanese Pharmacopoeia (JP), depending on the target market. These monographs define critical quality attributes such as assay, identification, impurity limits, and residual solvents.

2. How does a Drug Master File (DMF) impact API sourcing for the US market? A DMF, submitted to the FDA, contains confidential, detailed information about the API manufacturing process. Pharmaceutical companies referencing a DMF in their drug product applications (ANDA, NDA) can gain access to this information, allowing the FDA to review the API's manufacturing without the API manufacturer directly disclosing proprietary information to the drug product company. This is a key regulatory pathway for US market access.

3. What are the implications of a Certificate of Suitability (CEP) from the EDQM? A CEP from the European Directorate for the Quality of Medicines & HealthCare (EDQM) certifies that an API complies with the relevant monograph of the European Pharmacopoeia. It simplifies the regulatory process for drug product manufacturers seeking authorization in European Union member states and other countries that recognize CEPs, as it demonstrates a high level of quality control and adherence to European standards.

4. What is the typical lead time for bulk phenobarbital sodium API orders? Lead times can vary significantly based on the supplier's current production schedule, order volume, and geographic location. Generally, lead times can range from 4 to 12 weeks. Expedited orders may be possible but typically incur additional costs. It is crucial to negotiate specific lead times and delivery schedules within supply agreements.

5. What are the major risks associated with relying on a single API supplier? Relying on a single supplier creates significant risks, including potential supply disruptions due to manufacturing issues, natural disasters, regulatory actions against the supplier, or geopolitical instability. If the single supplier fails to meet quality or delivery expectations, it can lead to drug shortages, regulatory non-compliance, and significant financial losses for the drug product manufacturer.

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Citations

[1] United States Pharmacopeia. (n.d.). Phenobarbital Sodium. USP-NF. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability to the monographs of the European Pharmacopoeia. EDQM. [3] U.S. Food and Drug Administration. (n.d.). Drug Master Files: A User's Guide. FDA. [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). Impurities: Guideline for Residual Solvents Q3C(R7). ICH.