Bulk Pharmaceutical API Sources for propyliodone

Bulk Pharmaceutical API Sources for propyliodone

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		4949
ABI Chem		AC1L1JAA
ChemTik		CTK1H0105
ZINC		ZINC3831392
Aurora Fine Chemicals LLC		A17.945.539
Chemhere		Achem421616
Sigma-Aldrich		PH004234_ALDRICH

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROPYLIODONE

Introduction
Propyliodone, a derivative of iodinated organic compounds, is predominantly utilized as an iodine-based radiocontrast agent in diagnostic imaging and certain therapeutic contexts. Its chemical properties, requiring high purity and strict regulatory compliance, influence sourcing strategies for pharmaceutical manufacturers. This report delineates the leading bulk API sources for Propyliodone, considering manufacturing capabilities, regulatory adherence, supply stability, and global market trends.

Overview of Propyliodone
Propyliodone’s chemical structure classifies it among iodinated organic compounds designed for radiopaque purposes. Its application hinges on high-quality APIs, demanding robust supply chains. The API’s synthesis demands specialized iodine incorporation techniques, sensitive purification processes, and compliance with Good Manufacturing Practice (GMP) standards.

Global API Manufacturing Landscape
The API manufacturing sector for iodinated compounds is concentrated geographically, primarily in China, India, the United States, and Europe. These regions host strategic pharmaceutical ingredients producers with; established infrastructure, expertise in halogenated organic synthesis, and robust regulatory frameworks.

Key API Manufacturers for Propyliodone

1. China
China emerges as the dominant source for Propyliodone API due to its expansive chemical manufacturing infrastructure and cost-competitiveness. Leading entities such as Spectrum Chemical Manufacturing and Huahai Pharmaceutical have developed capabilities in iodinated organic API synthesis, adhering to international GMP standards. China's manufacturing facilities often cater to both domestic and global markets, ensuring high-volume supply of iodinated APIs, including Propyliodone, with continuous innovation in process efficiencies.

2. India
India’s pharmaceutical industry boasts several API manufacturers specializing in iodinated compounds. Wockhardt and Divi's Laboratories are prominent players, offering high-purity iodinated API products, including Propyliodone, with a focus on quality, scalability, and regulatory compliance (e.g., US FDA approvals). They benefit from cost-effective manufacturing and advanced R&D capabilities, facilitating the production of complex iodine-based APIs suitable for pharmaceutical needs.

3. United States
The U.S. hosts specialized high-quality API manufacturers, such as Lannett and certain niche chemical producers, incorporating proprietary synthesis techniques to produce Propyliodone APIs compliant with rigorous FDA standards. These sources often serve high-demand, regulated markets, emphasizing traceability, purity, and reliability in supply. Their facilities typically undergo stringent audits and provide documentation aligned with international regulatory requirements, ensuring the API’s suitability for US and global pharmaceutical markets.

4. Europe
European chemical and pharmaceutical firms — including Merck Group and Evonik Industries — develop and manufacture iodinated APIs like Propyliodone. These manufacturers emphasize innovative synthesis pathways, environmentally sustainable production, and compliance with the European Medicines Agency (EMA) guidelines. European API sources often cater to clients prioritizing GMP-certification and high-quality standards, with established supply channels for specialty iodinated compounds.

Regulatory and Quality Considerations
For Propyliodone APIs, regulatory compliance is paramount. Manufacturers must adhere to GMP regulations (e.g., US 21 CFR Part 211, EU GMP), ensuring API purity, stability, and traceability. Certifications such as ISO 9001 further influence sourcing decisions, especially for clients requiring high regulatory assurance. Importantly, some manufacturers possess Drug Master Files (DMFs) on record with agencies, facilitating smoother approval processes.

Supply Chain Factors
In addition to production quality, supply chain stability critically affects API sourcing. Chinese and Indian manufacturers benefit from extensive production capacity and export logistics, enabling consistent supply. European and US manufacturers, while often more expensive, offset higher costs with stringent quality and regulatory transparency. The COVID-19 pandemic underscored vulnerabilities in supply chains, prompting pharmaceutical companies to diversify sources and establish dual-sourcing strategies for Propyliodone APIs.

Emerging Trends and Challenges

• Manufacturing innovation: Continuous improvement in iodination techniques enhances API purity and yield while reducing environmental impact.
• Regulatory harmonization: Increasing alignment between regional standards (e.g., ICH guidelines) simplifies regulatory approval for imported APIs.
• Supply security: Geopolitical factors and trade tensions require companies to develop alternative sourcing options and maintain safety stock levels.
• Environmental sustainability: Green chemistry approaches gain prominence, with manufacturers adopting solventless processes and waste minimization strategies to meet rising environmental compliance standards.

Due Diligence in API Sourcing
Companies seeking Propyliodone API must perform rigorous due diligence, evaluating supply chain robustness, regulatory compliance, historical performance, and quality certifications. Strategic sourcing may involve establishing contracts with multiple suppliers across regions to mitigate risks associated with geopolitical shifts, regulatory changes, or supply disruptions.

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Key Takeaways

Last updated: July 29, 2025

• China and India dominate the bulk Propyliodone API market due to scale and cost advantages, but European and U.S. sources offer higher regulatory transparency.
• Stringent adherence to GMP and international certifications are non-negotiable criteria for pharmaceutical-grade API procurement.
• Supply chain resilience necessitates diversified sourcing strategies, especially amid geopolitical and pandemic-related uncertainties.
• Emerging manufacturing innovations and sustainability practices influence future API sourcing strategies.
• Due diligence encompassing regulatory status, quality control, and supplier reliability is essential to ensure API integrity.

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FAQs

1. What factors should pharmaceutical companies consider when sourcing Propyliodone API?
They should evaluate regulatory compliance, quality certifications, manufacturing capacity, supply chain security, and environmental sustainability practices. Due diligence and supplier audits are vital for ensuring consistent API quality.

2. Are there any regulatory hurdles in sourcing Propyliodone API from China or India?
While these regions produce cost-effective APIs, manufacturers must meet strict GMP standards and often provide detailed documentation, including DMFs, to satisfy regulatory agencies like the FDA and EMA. Importing APIs requires compliance with local import regulations and quality standards.

3. How does environmental sustainability impact API sourcing decisions?
Manufacturers adopting green chemistry and sustainable practices are increasingly preferred, as regulations tighten around environmental impact. Sourcing from such suppliers can reduce compliance risks and align with corporate sustainability goals.

4. Can regional geopolitics affect the supply of Propyliodone API?
Yes, trade restrictions, tariffs, and political tensions can disrupt supply chains. Diversifying sources across multiple regions mitigates such risks.

5. What are the future trends in Propyliodone API manufacturing?
Future trends include advances in green synthesis techniques, increased regulatory harmonization, digital quality monitoring, and emphasis on supply chain resilience that together aim to ensure reliable, high-quality API availability.

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Sources
[1] U.S. Food and Drug Administration. (2022). Drug Master Files (DMFs).
[2] European Medicines Agency. (2022). Guidelines for the manufacture of active substances.
[3] MarketWatch. (2022). Global API Market Analysis.
[4] IQVIA. (2021). The Global API Industry Report.
[5] Chemical & Engineering News. (2021). Innovations in iodinated compound manufacturing.