Bulk Pharmaceutical API Sources for povidone-iodine

Bulk Pharmaceutical API Sources for povidone-iodine

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		PVP1_SIGMA
NovoSeek		410087
MolPort		MolPort-003-959-367
ISpharm		I11-0272
ABI Chem		AC1L8YBR
ChemMol		49410925
Amadis Chemical		A817952

Bulk Active Pharmaceutical Ingredient (API) Sources for Povidone-Iodine

Last updated: July 31, 2025

Introduction

Povidone-iodine (PVP-I), a complex of polyvinylpyrrolidone and iodine, serves as a broad-spectrum antiseptic widely used in medical, surgical, and topical applications. Its efficacy against bacteria, fungi, viruses, and protozoa makes it an essential ingredient in disinfectants, wound care products, and surgical preparations. The increasing demand for povidone-iodine necessitates a robust supply chain of high-quality active pharmaceutical ingredients (APIs). This article explores global sources of povidone-iodine API, highlighting key manufacturers, quality standards, and supply considerations critical for industry stakeholders.

Understanding Povidone-Iodine API

Povidone-iodine's API component primarily comprises iodine complexed with polyvinylpyrrolidone (PVP). The iodine component is responsible for its antimicrobial activity, while PVP functions as a carrier, enhancing solubility, stability, and controlled release. The raw material procurement involves sourcing iodine and polymer intermediates, followed by complexation to produce the API. Quality attributes such as iodine content (generally 9-12%) and residual impurities are rigorously monitored to ensure compliance with pharmacopeial standards (USP, EP, JP).

Major Global API Manufacturers for Povidone-Iodine

1. South Korea

South Korea holds a significant share in the production of povidone-iodine API, owing to its advanced chemical manufacturing sector and stringent quality controls.

• DK Chemical: A leading supplier specializing in pharmaceutical-grade iodine compounds and PVP derivatives. DK Chemical offers povidone-iodine with consistent iodine content, complying with USP and EP standards. They emphasize quality control and GMP compliance, catering primarily to North American and European markets.

• Samjung Chemical: Known for their high-quality povidone-iodine API, with facilities adhering to international certifications. Their products are characterized by high purity, appropriate iodine concentration, and batch-to-batch consistency.

2. China

China's API manufacturing industry has expanded significantly, becoming a key global source due to cost advantages and manufacturing capacity.

• Chengdu Huaxing: Produces povidone-iodine API that meets international quality standards, with exports to North America, Europe, and Asia. Their facilities focus on GMP standards with comprehensive testing protocols for iodine content and residual impurities.

• Shandong Xinhua Pharmaceutical: Supplies povidone-iodine API with competitive pricing, extensive manufacturing experience, and adherence to pharmacopoeial standards. Their export portfolio includes stable iodine complexes suitable for disinfectant formulations.

• Nantong S&S Pharmaceutical: Offers customized povidone-iodine APIs tailored to client specifications with robust quality assurance measures.

3. United States

Although the U.S. has limited domestic production of povidone-iodine API, some specialized manufacturers and R&D-focused firms produce for niche markets or clinical trials.

• Vancive Medical Technologies (a provider of povidone-iodine formulations): Focuses on finished formulations, with APIs sourced through global supply chains with stringent quality standards.

• Contract manufacturing organizations (CMOs): Many U.S.-based CMOs source APIs from Asian suppliers, ensuring regulatory compliance and high-quality standards.

4. Europe

European manufacturers of povidone-iodine API are comparatively limited but focus on high-purity products for pharmaceutical and medical applications.

• BASF: Produces pharmaceutical-grade povidone compounds, including povidone-iodine, emphasizing purity, consistency, and compliance with GMP and pharmacopoeial standards.

• Vendors in Germany and the UK: Supply povidone-iodine APIs to European disinfectant and pharmaceutical industries, often sourcing from Asian suppliers while maintaining rigorous quality verification.

5. India

India's pharmaceutical sector is increasingly active in API manufacturing, including povidone-iodine.

• Shilpa Laboratories: Provides povidone-iodine API with GMP certification, satisfying domestic and export markets.

• Gufic Biosciences: Specializes in iodine-based APIs, including povidone-iodine, emphasizing reliable quality and regulatory compliance for global markets.

Supply Chain Dynamics and Quality Standards

Quality assurance remains pivotal when sourcing povidone-iodine API. Suppliers must adhere to international standards such as USP, EP, JP, and the ICH guidelines. Verification of iodine content, residual solvents, heavy metals, and microbial limits ensures API suitability for pharmaceutical applications.

The digestion of natural raw materials (iodine, PVP) and complexation processes require sophisticated manufacturing capabilities. Capacity constraints and geopolitical factors influence supply stability. Therefore, it is essential to establish long-term relationships with reputable manufacturers, prioritize suppliers with extensive documentation, and conduct third-party audits.

Regulatory Considerations

APIs used for pharmaceutical and antiseptic applications must comply with regulatory frameworks such as:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)
• WHO GMP guidelines

Manufacturers should possess comprehensive dossiers demonstrating API purity, stability, and safety profiles. Regulatory approval must be in place for market authorization, especially in strict jurisdictions like the U.S. and European Union.

Future Trends in API sourcing for Povidone-Iodine

The dynamic landscape of API sourcing will likely evolve with the following trends:

• Shift toward biosource raw materials: Enhanced focus on sustainably sourced iodine and biodegradable PVP variants.
• Adoption of continuous manufacturing: Improving scale-up efficiency and consistency.
• Development of novel complexes: Enhancing stability, bioavailability, and antimicrobial spectrum.
• Supply chain diversification: Reducing reliance on specific regions to mitigate geopolitical risks.

Conclusion

Sourcing high-quality povidone-iodine API demands strategic evaluation of manufacturer reliability, adherence to international standards, and supply chain resilience. South Korean and Chinese manufacturers dominate the market, offering cost-effective options with robust quality frameworks. European and Indian suppliers also provide premium options aligned with stringent regulatory requirements. As demand surges globally, establishing partnerships with reputable API producers is vital for pharmaceutical and disinfectant formulators aiming to maintain product integrity and compliance.

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Key Takeaways

• Major API sources for povidone-iodine are clustered in South Korea, China, India, and select European countries.
• Quality assurance aligned with pharmacopeial and regulatory standards is critical for sourcing povidone-iodine API.
• Long-term supplier relationships, rigorous audits, and comprehensive documentation underpin secure supply chains.
• Regulatory compliance (USP, EP, JP) and quality certifications (GMP) are non-negotiable criteria.
• Market trends favor sustainable raw materials, continuous manufacturing, and supply chain diversification to meet escalating global demand.

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FAQs

Q1: What are the primary quality attributes to verify in povidone-iodine API?
A1: The major attributes include iodine content (typically 9-12%), residual impurities, heavy metals, microbial limits, and compliance with pharmacopeial standards such as USP, EP, or JP.

Q2: Which regions are leading suppliers of povidone-iodine API?
A2: South Korea and China are the dominant sources globally, with significant contributions from India and Europe for high-purity products.

Q3: How do quality standards impact the selection of povidone-iodine API suppliers?
A3: Suppliers must demonstrate adherence to GMP, produce certificates of analysis, and comply with regional pharmacopoeias. These ensure product safety, efficacy, and regulatory approval.

Q4: What are the regulatory considerations when sourcing povidone-iodine API?
A4: Suppliers should possess comprehensive dossiers demonstrating API purity, stability, and safety, with approval from relevant health authorities like the FDA, EMA, or PMDA.

Q5: How is the supply chain risk for povidone-iodine API managed?
A5: By diversifying suppliers across regions, conducting regular audits, maintaining safety stock, and fostering transparent communication for forecasting and quality assurance.

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References

[1] United States Pharmacopeia (USP). General Chapters.

[2] European Pharmacopoeia (EP). Monograph on Povidone-Iodine.

[3] World Health Organization (WHO). Guidelines on the quality, safety, and efficacy of povidone-iodine.

[4] Industry Reports on API Manufacturing in South Korea and China.

[5] "Global API Market Analysis," Pharma Intelligence 2022.