Bulk Pharmaceutical API Sources for DIPRIVAN

Bulk Pharmaceutical API Sources for DIPRIVAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D126608_ALDRICH
Sigma-Aldrich		W505102_ALDRICH
TCI (Tokyo Chemical Industry)		D0617
Hangzhou APIChem Technology		AC-2038
Amadis Chemical		A814898

Bulk Active Pharmaceutical Ingredient (API) Sources for DIPRIVAN (Propofol)

Last updated: July 30, 2025

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Introduction

DIPRIVAN, with the generic name Propofol, is a widely used intravenous anesthetic agent primarily indicated for the induction and maintenance of anesthesia, as well as sedation in intensive care units. Given its critical role in anesthesia, the supply chain for its active pharmaceutical ingredient (API) is crucial to ensure continuous availability, stability, and compliance with regulatory standards. This article delineates the landscape of bulk API sources for Propofol, key manufacturing regions, regulatory considerations, and the implications for pharmaceutical stakeholders.

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Overview of Propofol API Manufacturing

Propofol's API synthesis involves complex chemical processes requiring high purity levels. The API's quality directly impacts safety and efficacy, making reliable sourcing essential. Major pharmaceutical companies and chemical manufacturers globally produce and supply Propofol API, with regions like Europe, Asia, and North America forming the backbone of the supply chain.

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Major API Producers for Propofol

1. Global Leaders in API Production

a. Multiple Large-Scale Manufacturers
Leading pharmaceutical and chemical companies hold active manufacturing units for Propofol API, with certifications such as Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) being prerequisites for supplying commercial quantities.

• Ajinomoto Co., Inc. (Japan)
  A significant player in API manufacture, Ajinomoto supplies Propofol API primarily to Asian markets but has expanded globally through partnerships and exports. Their manufacturing facilities are USFDA and EMA compliant, ensuring high-quality standards.

• CSBio Co., Ltd. (South Korea)
  A recognized supplier in Asia, CSBio offers high-quality Propofol API, targeting both domestic and international markets, often under strict regulatory oversight.

• Sirnas Pharma (India)
  This Indian manufacturer has gained regulatory approvals for Propofol API, supplying both domestic and international clients, including hospitals and pharmaceutical integrators.

• TexaPharm (Spain)
  Operating in Europe, TexaPharm manufactures Propofol API compliant with EMA standards, supplementing global supply chains.

b. Contract Manufacturing Organizations (CMOs)
Numerous CMOs serve as third-party producers, offering Propofol API under contractual agreements, which can serve as supplementary sources during supply disruptions.

2. Regional Supply Insights

Asia-Pacific

Asia, especially China and India, dominates API production due to cost advantages and established chemical manufacturing infrastructure.

• China
  Hosts numerous API manufacturers with capacities for Propofol, often exporting API globally. Regulatory oversight varies, requiring due diligence for quality and compliance.

• India
  A key supplier with multiple GMP-certified API producers, providing both bulk API and intermediates for Propofol synthesis.

Europe

European manufacturers emphasize high regulatory compliance, quality assurance, and industrial scale, serving markets with stringent criteria such as the EU and US.

• Spain, Germany, and France
  Countries boasting GMP-compliant facilities capable of large-scale API production for Propofol.

North America

• United States
  The US hosts API manufacturers mainly serving domestic needs, with companies like Bedford Labs (a division of Radiant Life Technologies) involved in Propofol API production.

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Supply Chain and Regulatory Considerations

Maintaining a resilient API supply chain involves careful assessment of supplier credibility, manufacturing standards, and logistic capabilities. Regulatory approval status (FDA, EMA, PMDA) is essential for legal commercialization.

• GMP Compliance:
  Only suppliers adhering to GMP standards are considered reliable for API production, ensuring batch-to-batch consistency, purity, and safety.

• Quality Certifications:
  Certificates of Analysis (CoA), Drug Master Files (DMF), and inspection reports are critical documentation for validating API sources.

• Regulatory Approvals:
  Suppliers with approvals from the USFDA, EMA, or other stringent regulatory authorities offer greater assurance of quality and regulatory compliance.

• Supply Chain Risks:
  Geopolitical tensions, regulatory changes, and manufacturing disruptions in regions like China can affect API availability, necessitating diversification of sources.

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Emerging Trends and Challenges

• Supply Chain Diversification:
  There's growing emphasis on establishing multiple API sources to mitigate risks associated with dependence on a limited number of suppliers or regions.

• API Quality and Compliance Enhancements:
  Increasing regulatory scrutiny prompts suppliers to upgrade facilities and processes, ensuring high standards for API purity and traceability.

• Sustainability and Environmental Standards:
  Manufacturers are adopting greener processes and waste management practices to align with evolving environmental standards.

• Cost Dynamics:
  Cost advantages in Asian manufacturing regions can be offset by quality assurance costs and logistical considerations, influencing sourcing strategies.

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Key Considerations for Pharmaceutical Stakeholders

• Due Diligence:
  Thorough vetting of API suppliers concerning compliance history, capacity, and quality certifications.

• Supply Chain Flexibility:
  Developing relationships with multiple sources across regions enhances buying power and mitigates supply disruptions.

• Regulatory Alignment:
  Ensuring that API sources meet local and international regulatory requirements to prevent approval delays or market restrictions.

• Cost versus Quality Trade-offs:
  Balancing the financial benefits of sourcing from cost-efficient regions against the imperative of high-quality, compliant API.

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Conclusion

The landscape of Propofol API manufacturing and sourcing is characterized by diverse regional players, stringent regulatory environments, and evolving supply chain dynamics. Asia-Pacific, particularly China and India, remains dominant, complemented by European manufacturers emphasizing quality and compliance. Pharmaceutical companies must implement robust supply chain management strategies—diversifying sources, ensuring regulatory adherence, and maintaining quality—to secure uninterrupted supplies of Propofol API.

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Key Takeaways

• The global Propofol API supply chain is led by manufacturers in Asia, Europe, and North America, with notable players across each region.
• Ensuring GMP compliance and regulatory approval from authorities like the FDA and EMA is vital for API sourcing reliability.
• Diversification of suppliers and regions can mitigate risks associated with geopolitical or regulatory disruptions.
• Continuous monitoring of manufacturing standards and environmental practices aligns suppliers with evolving industry expectations.
• Strategic partnerships with reputable API manufacturers underpin stable Propofol supply, essential for anesthetic and sedation services.

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FAQs

1. What are the primary regions producing Propofol API?
Asia-Pacific (especially China and India), Europe (Spain, Germany, France), and North America (USA) are the main production regions, each offering unique advantages in terms of cost, quality, and regulatory standards.

2. How do regulatory standards impact API sourcing for Propofol?
Regulatory standards like GMP, FDA, and EMA approvals serve as quality benchmarks, ensuring safety, efficacy, and legal compliance, thereby influencing supplier selection and supply chain stability.

3. Is China a reliable source of Propofol API?
While China is a significant producer with capacity and cost advantages, due diligence regarding regulatory compliance, quality certifications, and inspection reports is essential for responsible sourcing.

4. What risks are associated with sourcing Propofol API globally?
Risks include supply disruptions due to geopolitical tensions, manufacturing disruptions, regulatory non-compliance, and quality variability, emphasizing the need for diversified and compliant sources.

5. How can pharmaceutical companies mitigate API supply chain risks?
Via strategic supplier relationships, multi-region sourcing, extensive quality assessments, and maintaining regulatory and logistical flexibility, companies can secure consistent Propofol API supplies.

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Sources:

1. [1] International Pharmaceutical Regulators Forum (IPRF). API Manufacturing Standards and Compliance. 2022.
2. [2] Pharma Logistics and Supply Chain Reports. (2023). Impact of Regional Disruptions on API Supply Chains.
3. [3] European Medicines Agency (EMA). Guidance on API Quality Standards. 2022.
4. [4] U.S. Food and Drug Administration (FDA). API Registration and Compliance Guidelines. 2023.
5. [5] Industry Market Reports. Global Propofol API Market Overview. 2023.