Bulk Pharmaceutical API Sources for PENTOTHAL

Bulk Pharmaceutical API Sources for PENTOTHAL

Vendor	Vendor Homepage	Vendor Sku	API Url
Key Organics/BIONET		KS-1432
AKos Consulting & Solutions		AKOS025392174
Clearsynth		CS-O-30788
Ambinter		Amb10843628
Chem-Space.com Database		CSSS00009881804
AKos Consulting & Solutions		AKOS037653994

Bulk Active Pharmaceutical Ingredient (API) Sources for: PENTOTHAL

Last updated: July 30, 2025

Introduction

Pentothal, chemically known as Thiopental Sodium, is a barbiturate anesthetic agent traditionally used in inducing anesthesia and facilitating surgical procedures. Its role in anesthesia is notable for rapid onset, but usage has declined due to evolving safety concerns and the emergence of newer agents. Nonetheless, pentothal remains commercially available, primarily sourced from specialized API manufacturers. This article details leading global sources, manufacturing trends, and considerations for procurement of bulk Pentothal APIs.

Overview of Pentothal and API Market Dynamics

Thiopental sodium's API form is a critical component, enabling pharmaceutical companies to produce anesthetic formulations. The API's quality, regulatory compliance, and supply security directly influence the availability and pricing of pentothal-based medications. Historically, API manufacturing was concentrated in regions with advanced chemical synthesis capabilities, including China, India, and Europe (particularly Spain and Germany).

The API market for pentothal is characterized by tightly regulated manufacturing practices aligned with Good Manufacturing Practices (GMP), ensuring purity and batch consistency. The number of API suppliers specializing in barbiturates has decreased over recent years, owing to tighter regulations and declining demand. Nevertheless, select manufacturers continue to supply high-quality pentothal API for both domestic and export purposes.

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Major API Suppliers for Pentothal (Thiopental Sodium)

1. H.C. Starck (Germany)

   H.C. Starck, now part of Global Tungsten & Powders (GTP) and other entities, historically supplied Thiopental sodium to European markets. Their manufacturing facilities adhere to stringent GMP standards, covering both the API and finished formulations. The company's reputation for quality and compliance makes it a valuable source for large-scale procurement.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

   As a prominent Chinese pharmaceutical manufacturer specializing in specialized APIs, Jiangsu Hengrui produces Thiopental Sodium with certified GMP compliance. They focus on high-purity API production, catering to both domestic and international markets. The company's scale allows competitive pricing and reliable supply.

3. Siegfried AG (Switzerland)

   Siegried's API division offers a range of injectable active pharmaceutical ingredients, including Thiopental Sodium. Their GMP-certified manufacturing sites ensure consistent product quality. Siegfried emphasizes regulatory compliance, critical for anesthetic APIs subjected to stringent international standards.

4. Fujian Maixin Pharmaceuticals Co., Ltd. (China)

   This manufacturer specializes in producing barbiturates and other CNS-active compounds. Their Thiopental Sodium API features high purity, meeting international pharmacopoeial standards. The company has gained recognition for quality assurance protocols.

5. Shandong Lanhesheng Pharmaceutical Co., Ltd. (China)

   Focused on CNS-targeted APIs, this company supplies Thiopental Sodium to various markets. They emphasize GMP compliance, with a track record of consistent production batches, making them a prospective source for bulk procurement.

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Emerging Trends and Supply Chain Considerations

• Regulatory Compliance and Quality Assurance:
  Suppliers must adhere to international standards, including FDA, EMA, and WHO GMP certifications. This compliance guarantees API purity, stability, and consistent batch-to-batch performance vital for anesthetic applications.

• Manufacturing Region and Regulatory Divergences:
  Chinese API manufacturers dominate the supply landscape, driven by lower production costs and capacity scale. However, procurement from Chinese suppliers necessitates rigorous due diligence to ensure compliance with importing country regulations.

• Market Availability and Demand Shifts:
  With declining clinical use, some suppliers have scaled down production or exited the market, potentially affecting supply security. The COVID-19 pandemic further disrupted supply chains globally, emphasizing the need for diversified sourcing strategies.

• Pricing Dynamics:
  API prices are influenced by raw material costs, regulatory hurdles, and geopolitical factors. Buyers should anticipate fluctuation and establish long-term relationships with reliable suppliers.

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Regulatory and Quality Considerations for Procurement

When sourcing Pentothal API, sourcing entities must ensure:

• GMP Certification: Validates compliance with recognized pharmaceutical manufacturing standards.
• Certificate of Analysis (CoA): Confirms chemical purity, sterility (if applicable), and appropriate specifications.
• Manufacturing Site Inspection Reports: For assurance of quality management systems.
• Stability Data: Demonstrating consistent product quality during shelf life.

It is vital to verify the supplier’s manufacturing licenses and conduct audits, especially if sourcing directly for regulatory submission or high-stakes clinical use.

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Key Challenges and Solutions in API Sourcing

• Limited Supplier Pool:
  To mitigate supply disruptions, establish multi-source agreements with reputable manufacturers who hold stringent certifications and proven track records.

• Regulatory Barriers:
  Ensure thorough vetting of CMC data and quality documentation for smooth import and registration procedures in target markets.

• Intellectual Property Constraints:
  Although APIs like Thiopental Sodium are generally unpatented at this stage, confirm any applicable exclusivities or regional restrictions.

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Future Outlook for Pentothal API

While demand for pentothal has declined in favor of newer anesthetic agents with improved safety profiles, niche applications in specific contexts (e.g., research, specialized anesthesia) sustain the API market. Consequently, manufacturers continue to produce high-quality API sources mainly for legacy use.
However, market volatility and increased regulatory scrutiny mean procurement strategies must be cautious, emphasizing quality assurance and supply durability.

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Key Takeaways

• Major global suppliers of Pentothal API include European firms like H.C. Starck and Swiss companies like Siegfried, along with key Chinese manufacturers such as Jiangsu Hengrui and Shandong Lanhesheng.
• Ensure suppliers possess up-to-date GMP certification, comprehensive CoAs, and robust quality management systems.
• Supply chain diversification and rigorous qualification processes are essential given the limited market players and regulation-driven market dynamics.
• Buyers should monitor regulatory updates impacting API importation and stay compliant with evolving international standards.
• Despite declining demand, high-quality API procurement remains critical for legacy and specialized clinical uses.

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FAQs

1. What are the primary regions producing Thiopental Sodium API today?
   The leading regions include China, Europe (notably Switzerland, Germany), with Chinese manufacturers dominating due to cost advantages and capacity.

2. What quality certifications should I verify before sourcing the API?
   GMP certification, the Certificate of Analysis, manufacturing licenses, and compliance with relevant pharmacopoeial standards (e.g., USP, EP, JP).

3. Are there alternatives to Thiopental Sodium in anesthesia?
   Yes, agents like Propofol, Etomidate, and inhalational anesthetics are increasingly used, but Thiopental remains available for specific indications.

4. How does regulatory compliance influence API purchasing decisions?
   It ensures product safety, efficacy, and facilitates regulatory approval processes, minimizing legal and clinical risks.

5. What logistical considerations should I keep in mind for API procurement?
   Shipping regulations for hazardous materials, import tariffs, storage stability, and customs clearance procedures are critical factors impacting delivery.

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References

[1] Market analysis reports on anesthetic APIs, 2022.
[2] WHO and EMA pharmaceutical manufacturing standards.
[3] Industry publications detailing API supplier profiles.
[4] Regulatory guidelines on GMP certification and API importation.