Suppliers and packagers for generic pharmaceutical drug: PENTOBARBITAL SODIUM

PENTOBARBITAL 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
Hikma	PENTOBARBITAL SODIUM	pentobarbital sodium	INJECTABLE;INJECTION	203619	ANDA	Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)	24201-010-20	1 VIAL in 1 CARTON (24201-010-20) / 20 mL in 1 VIAL	2018-02-26
Hikma	PENTOBARBITAL SODIUM	pentobarbital sodium	INJECTABLE;INJECTION	203619	ANDA	Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)	24201-010-50	1 VIAL in 1 CARTON (24201-010-50) / 50 mL in 1 VIAL	2018-02-26
Sagent Pharms Inc	PENTOBARBITAL SODIUM	pentobarbital sodium	INJECTABLE;INJECTION	206404	ANDA	Sagent Pharmaceuticals	25021-676-20	1 VIAL in 1 CARTON (25021-676-20) / 20 mL in 1 VIAL	2017-04-19
Sagent Pharms Inc	PENTOBARBITAL SODIUM	pentobarbital sodium	INJECTABLE;INJECTION	206404	ANDA	Sagent Pharmaceuticals	25021-676-50	1 VIAL in 1 CARTON (25021-676-50) / 50 mL in 1 VIAL	2017-04-19

Suppliers for the Pharmaceutical Drug: Pentobarbital Sodium

Last updated: July 29, 2025

Introduction

Pentobarbital sodium, a barbiturate derivative, has historically been utilized in clinical settings for anesthesia, sedation, and as an emergency anticonvulsant. However, due to regulatory controls, its production, supply chain, and distribution are highly regulated and limited to authorized entities such as pharmaceutical manufacturers, compounding pharmacies, and government agencies. This analysis explores the active suppliers of pentobarbital sodium globally, their roles, regulatory considerations, and market dynamics shaping the supply landscape.

Regulatory Landscape and Market Context

Pentobarbital sodium is classified as a controlled substance under Schedule II or III depending on the jurisdiction, owing to its high potential for misuse and dependency (e.g., U.S. Drug Enforcement Administration [DEA], [1]). Consequently, its manufacturing and distribution require compliance with strict licensing, record-keeping, and security protocols.

The drug's use has decreased in some applications due to the advent of alternative therapies; however, it remains vital for specific medical, research, and legal purposes—most notably, in physician-assisted euthanasia and capital punishment protocols in certain jurisdictions, as well as veterinary medicine.

Key Suppliers and Manufacturers

1. Chemicals Manufacturers and Bulk Suppliers

a. SIGMA-ALDRICH (Merck Group)
One of the world’s leading suppliers of fine chemicals, Sigma-Aldrich supplies research-grade pentobarbital sodium for laboratories and veterinary use. Their products are subject to stringent legal controls and are primarily available for research institutions and authorized entities. Sigma-Aldrich’s supply chain is global, with extensive distribution networks ([2]).

b. MilliporeSigma (Now part of Merck KGaA)
As a major provider of specialty chemicals, MilliporeSigma supplies high-purity pentobarbital sodium, primarily for research and veterinary applications. They comply with international regulatory standards and operate under strict licensing policies ([3]).

c. Tocris Bioscience
Focused on research-grade pharmacological tools, Tocris offers pentobarbital sodium for neuroscience, anesthesia, and research applications. Their distribution is primarily to academic and research institutions, with strict adherence to regulatory stipulations ([4]).

2. Pharmaceutical Manufacturers

a. Par Pharmaceutical Companies
Certain pharmaceutical firms possess manufacturing capabilities or licensing arrangements for pentobarbital sodium. Historically, U.S.-based firms such as Par Pharmaceutical (now part of Endo International) produced formulary-grade pentobarbital sodium for hospital and legal use. Production is heavily regulated under the FDA, and supplies often come through authorized distribution channels ([5]).

b. International Pharmaceutical Manufacturers
Manufacturers in countries with less restrictive drug control policies, such as certain European or Asian nations, produce pentobarbital sodium for licensed medical use. These companies usually operate under national pharmaceutical regulatory agencies, like the EMA in Europe or the PMDA in Japan. Exact suppliers often operate under tight licensing and export controls ([6]).

3. Compounding Pharmacies & Special Suppliers

In jurisdictions where authorized, compounding pharmacies may source bulk pentobarbital sodium from licensed chemical suppliers to prepare formulations for euthanasia or sedation procedures. Access is typically limited to medical institutions with proper licensing due to legal restrictions.

Market Dynamics and Supply Chain Considerations

Regulatory Constraints

The supply chain for pentobarbital sodium is tightly controlled. Manufacturers must navigate complex licensing, import-export restrictions, and recordkeeping to prevent diversion for illicit purposes. This limits the number of authorized suppliers and emphasizes the importance of verified, compliant sources.

Manufacturing Challenges

Production is dependent on the availability of precursor chemicals, adherence to Good Manufacturing Practices (GMP), and compliance with international drug control treaties such as the UN Convention on Psychotropic Substances. Disruptions—whether due to regulatory changes, geopolitical issues, or manufacturing problems—can impact supply.

Market Scarcity and Ethical Concerns

Due to ethical debates surrounding euthanasia and capital punishment, supply chains are scrutinized more intensively. Some manufacturers withdraw from producing pentobarbital sodium altogether, citing legal and ethical concerns, leading to shortages in certain regions and an increased reliance on limited suppliers.

Emerging Trends and Future Outlook

• Regulatory tightening: Ongoing international efforts aim to curtail illicit diversion, further constraining legal supply.

• Alternative sedatives: Increased utilization of benzodiazepines and other agents reduces dependence on pentobarbital sodium, impacting demand and supply stability.

• Innovations in manufacturing: Manufacturers investing in secure, compliant production methods aim to stabilize supplies for legitimate medical and research needs.

• Market consolidation: Mergers and licensing agreements may reduce the number of independent suppliers, concentrating supply among a few regulated manufacturers.

Conclusion

The supply landscape of pentobarbital sodium is characterized by a limited number of highly regulated, licensed suppliers primarily engaged in research, veterinary, or specific clinical uses. Key players include chemical giants like Sigma-Aldrich and MilliporeSigma, alongside specialized pharmaceutical manufacturers operating under strict regulatory oversight. Despite regulatory constraints and ethical debates, these suppliers play crucial roles in maintaining a controlled, compliant supply chain vital for legitimate applications.

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Key Takeaways

• Limited and regulated supply: Only authorized manufacturers and distributors supply pentobarbital sodium, governed by strict international and national laws.

• Major suppliers include Sigma-Aldrich and MilliporeSigma: They provide research-grade materials to licensed entities worldwide, adhering to compliance standards.

• Regulatory and ethical constraints: These heavily influence supply availability, with potential shortages stemming from legal restrictions or ethical considerations.

• Market consolidation: Mergers and licensing agreements are shaping a smaller supplier base, emphasizing compliance and security.

• Future market stability: Dependent on regulatory policies, alternative therapies, and ongoing ethical debates impacting demand and supply.

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FAQs

1. Who are the primary suppliers of pharmaceutical-grade pentobarbital sodium?
Key suppliers include companies like Sigma-Aldrich (Merck) and MilliporeSigma, which provide research and veterinary-grade pentobarbital sodium under strict licensing. Pharmaceutical-grade formulations for human medical use are produced by licensed pharmaceutical manufacturers, often within regulated markets like the US and Europe.

2. Is pentobarbital sodium available for non-medical or illicit use?
No. Due to its Schedule II or III classification worldwide, pentobarbital sodium's distribution is highly restricted. Unauthorized possession or use is illegal, and diversion is actively monitored and prosecuted.

3. How do regulatory authorities control pentobarbital sodium supply?
Authorities require licensing for manufacturing, import-export controls, record-keeping, and secure storage. Agencies such as the DEA (US) or EMA (Europe) oversee licensing and ensure compliance with international treaties like the UN Convention on Psychotropic Substances.

4. Are there regional differences in pentobarbital sodium suppliers?
Yes. In countries with strict drug control laws, supply is limited primarily to domestic licensed manufacturers or authorized distributors. In less regulated regions, supply may come from international sources, though legal access remains tightly controlled.

5. Will supply shortages occur in the future?
Potentially. Regulatory changes, ethical debates around euthanasia, manufacturing challenges, or geopolitical issues could disrupt supply. The market is sensitive to legal shifts, and manufacturers may cease production amid ethical or legal concerns, affecting availability.

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References

[1] US Drug Enforcement Administration. Schedules of controlled substances. DEA, 2022.
[2] Sigma-Aldrich. Chemical products and safety data sheets. Merck KGaA, 2022.
[3] MilliporeSigma. Specialty chemical supply chain overview. Merck KGaA, 2022.
[4] Tocris Bioscience. Research chemicals portfolio. Tocris, 2022.
[5] US Food and Drug Administration. Pharmaceutical manufacturing standards. FDA, 2022.
[6] European Medicines Agency. Regulatory overview of controlled substances. EMA, 2022.