Suppliers and packagers for generic pharmaceutical drug: phenobarbital sodium

phenobarbital sodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	SEZABY	phenobarbital sodium	POWDER;INTRAVENOUS	215910	NDA	Sun Pharmaceutical Industries, Inc.	62756-301-01	1 INJECTION in 1 VIAL, SINGLE-DOSE (62756-301-01)	2022-12-25

Last updated: November 7, 2025

ppliers for the Pharmaceutical Drug: Phenobarbital Sodium

Introduction
Phenobarbital sodium, a long-standing barbiturate primarily used as an anticonvulsant and sedative, continues to play a role in managing epilepsy, sedation, and anesthetic protocols globally. Its production and supply chain are highly regulated due to its potential for misuse and dependence. Understanding the key suppliers, their manufacturing capabilities, and the sourcing landscape is vital for healthcare providers, distributors, and regulatory authorities aiming to ensure consistent access and compliance.

Global Manufacturing Landscape

1. Major Pharmaceutical Companies and Contract Manufacturing Organizations (CMOs)
The supply of phenobarbital sodium is dominated by a handful of large pharmaceutical firms and specialized CMOs. These entities possess the requisite regulatory approvals, manufacturing expertise, and quality assurance systems to produce pharmaceutical-grade product at scale. Notable companies include:

• Fenbarbital GmbH – A European-based manufacturer with longstanding experience in barbiturates, offering phenobarbital sodium for global markets. Their production complies with Good Manufacturing Practice (GMP) standards, ensuring consistency and safety.
• Mingtai Chemical Co., Ltd. – A leading Chinese API manufacturer that produces phenobarbital sodium in bulk, primarily serving Asian and international markets through export channels. Their facilities are certified by the Taiwan FDA and adhere to strict quality controls.
• Zhejiang Yimia Chemical Co., Ltd. – A Chinese API supplier specializing in modulatory compounds including phenobarbital sodium. Their offerings include both bulk API and finished formulations tailored for various prescription needs.

2. Contract Manufacturing and Exporters
Several CROs and CMOs in India and China have developed capabilities to produce phenobarbital sodium under strict regulatory standards, often supplying generic versions to meet market demand at competitive prices. These suppliers typically operate under licensing agreements with patent holders or produce off-patent formulations.

Regulatory Considerations
The manufacturing and distribution of phenobarbital sodium are tightly regulated under international drug control treaties, notably the Single Convention on Narcotic Drugs (1961), given its classification as a controlled substance. Suppliers must comply with the Drug Enforcement Administration (DEA) regulations in the U.S., the European Medicines Agency (EMA) standards across Europe, and respective national agencies elsewhere. This regulation impacts supply chain transparency, licensing, and import/export procedures.

Key Supplier Profiles

Supplier	Country of Origin	Certification & Compliance	Capacity & Market Focus	Notes
Fenbarbital GmbH	Germany	EMA GMP, cGMP certifications	European, North American, Middle Eastern	Focuses on high-quality APIs; longstanding market presence
Mingtai Chemical Co., Ltd.	Taiwan (China)	Taiwan FDA, GMP	Asia-Pacific, exporting globally	Large scale API producer; cost-competitive
Zhejiang Yimia Chemical Co., Ltd.	China	WHO GMP, Chinese SFDA	Asian markets, emerging markets	Offers both API and finished dosage forms
Jinan Yinhua Chemical Co. Ltd.	China	GMP, ISO certifications	Asia, Latin America	Flexibility in supply; affordable pricing
Fujian Jinghua Pharmaceutical	China	GMP, WHO certifications	Asia, emerging markets	Focus on generics and APIs

Supply Chain Challenges and Considerations

1. Regulatory Barriers
Due to its classification, phenobarbital sodium faces strict licensing, record-keeping, and reporting requirements. Import/export licenses can delay supply, especially in countries with tight controls or political restrictions.

2. Quality Assurance
The variable quality of APIs from different suppliers can affect therapeutic efficacy and safety. Healthcare entities must insist on third-party testing, certification, and auditing before procurement. Certification from internationally recognized bodies such as the U.S. FDA, EMA, or WHO is crucial for international transactions.

3. Price Sensitivity and Generic Competition
Generic phenobarbital sodium from Chinese and Indian suppliers offers substantial cost advantages, exerting pressure on established Western manufacturers to maintain competitive pricing. This price competition facilitates broader access but raises concerns over quality consistency.

4. Geopolitical and Supply Disruptions
Given the regional concentration of manufacturing in China and India, geopolitical tensions, trade restrictions, or supply chain disruptions can impact availability. Diversification of suppliers and regional manufacturing centers is increasingly important.

5. Environmental and Ethical Compliance
Manufacturers are increasingly scrutinized for sustainable practices, waste management, and ethical sourcing. Compliance with international environmental standards influences supplier selection.

Market Outlook and Strategic Implications

Sourcing Strategy
Healthcare providers and distributors should prioritize suppliers with rigorous quality control, GMP compliance, and transparent regulatory documentation. Establishing relationships with multiple vendors mitigates risks tied to regulatory or geopolitical challenges.

Regulatory Vigilance
Regulatory updates regarding controlled substances, global bans, or reporting mandates must inform procurement decisions. Regular audits and supplier certifications are essential for ongoing compliance.

Emerging Alternatives
The pharmaceutical industry continues to develop alternatives to phenobarbital sodium, including newer anticonvulsant agents with lower abuse potential. While demand for phenobarbital remains stable in specific markets, diversification with alternative therapies may be advisable for long-term strategic planning.

Final Remarks
The global phenobarbital sodium supply chain hinges on a limited number of specialized manufacturers operating under stringent regulatory frameworks. While well-established suppliers from Europe and Asia dominate the scene, new entrants often struggle with regulatory hurdles and quality assurance, making due diligence critical. The confluence of regulatory oversight, geopolitical factors, and market pricing underscores the importance of strategic supplier management to ensure continuous, compliant, and cost-effective access.

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Key Takeaways

• Dominant Suppliers: European entities like Fenbarbital GmbH and Chinese manufacturers such as Mingtai Chemical lead global phenobarbital sodium supply.
• Regulatory Complexity: Stringent international controls necessitate robust compliance and licensing, influencing capture of supply chain risks.
• Quality and Certification: Partnerships should be predicated on GMP and regulatory certifications to ensure medication safety and efficacy.
• Market Risks: Geopolitical tensions and regional disruptions demand supplier diversification strategies.
• Future Outlook: Industry trends favor generic producers in Asia; ongoing regulatory vigilance and quality assurance will remain critical.

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FAQs

Q1: What are the primary regulatory challenges in sourcing phenobarbital sodium?
A1: As a controlled substance under international treaties like the Single Convention on Narcotic Drugs, phenobarbital sodium requires strict licensing, documentation, and compliance checks in import/export processes, posing logistical and legal hurdles for suppliers and buyers alike.

Q2: How can healthcare organizations verify the quality of phenobarbital sodium from suppliers?
A2: Verification involves reviewing GMP certificates, requesting third-party testing reports, conducting supplier audits, and ensuring products are sourced from certified manufacturers compliant with EMA, FDA, or WHO standards.

Q3: What regions dominate phenobarbital sodium manufacturing today?
A3: China and India account for the majority of API manufacturing, including phenobarbital sodium, leveraging cost advantages and large-scale production capabilities, supplemented by European producers emphasizing quality and regulatory compliance.

Q4: Are there alternatives to phenobarbital sodium for epilepsy management?
A4: Yes, newer anticonvulsants such as levetiracetam, lamotrigine, and topiramate offer effective seizure control with a lower abuse potential; adoption depends on regulatory approvals, clinical considerations, and specific patient needs.

Q5: How might geopolitical tensions impact phenobarbital sodium supply?
A5: Tensions may lead to trade restrictions, export bans, or increased regulatory scrutiny, disrupting supply chains, especially given regional manufacturing concentrations. Diversification and regional sourcing can mitigate such risks.

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References

1. United Nations Office on Drugs and Crime. Single Convention on Narcotic Drugs, 1961 (Multiple Amendments).
2. European Medicines Agency. Good Manufacturing Practice (GMP) Guidelines.
3. U.S. Drug Enforcement Administration. Controlled Substances Act and Manufacturing Regulations.
4. Chinese State Food and Drug Administration (SFDA). API Manufacturing Standards.
5. Industry reports on pharmaceutical raw material markets, 2022–2023.