iodine povacrylex; isopropyl alcohol: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
3m	DURAPREP	iodine povacrylex; isopropyl alcohol	SPONGE;TOPICAL	021586	NDA	Solventum US LLC	17518-011-07	1 APPLICATOR in 1 CASE (17518-011-07) / 6 mL in 1 APPLICATOR	2006-09-29
3m	DURAPREP	iodine povacrylex; isopropyl alcohol	SPONGE;TOPICAL	021586	NDA	Solventum US LLC	17518-011-08	1 APPLICATOR in 1 CASE (17518-011-08) / 26 mL in 1 APPLICATOR	2006-09-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical industry relies heavily on a robust supply chain for active pharmaceutical ingredients (APIs) and excipients. Two commonly used antiseptics—iodine povacrylex and isopropyl alcohol—serve critical roles in medical settings, including surgical hand scrubs, skin preparation, and disinfection procedures. Their sourcing dictates product safety, efficacy, and compliance with regulatory standards. This report examines the key suppliers of iodine povacrylex and isopropyl alcohol, analyzing their market presence, manufacturing capacity, and compliance credentials, to facilitate strategic procurement decisions.

I. Iodine Povidrylex: Overview and Suppliers

Iodine povacrylex is a complex iodine-releasing antiseptic embedded in a polymer matrix, primarily used for skin disinfection before surgeries or invasive procedures. Its stability, broad-spectrum antimicrobial activity, and reduced staining make it preferred in clinical settings.

A. Major Suppliers of Iodine Povidrylex

3M Health Care
- Overview: 3M is a leading global supplier of medical and surgical antiseptics, including povidrylex-based formulations.
- Product Range: 3M manufactures betadine surgical scrub, which contains iodine povacrylex as a key component.
- Market Share & Reach: As a pioneer in antiseptics, 3M supplies to hospitals worldwide, with extensive distribution channels.
- Regulatory Compliance: Products adhere to FDA, EMA, and other global standards.
Mundipharma
- Overview: Mundipharma markets povidrylex formulations in select regions, particularly Europe and Asia.
- Product Offerings: Offers povidrylex-based antiseptic solutions, often integrated into surgical skin prep kits.
- Strengths: Known for high-quality manufacturing and regional distribution.
Ecolab Inc.
- Overview: A global leader in infection prevention solutions, Ecolab offers iodine-based antiseptics, including povidrylex formulations.
- Markets: Supplies hospitals, clinics, and industrial cleaning sectors.
- Supply Capabilities: Extensive manufacturing facilities ensuring consistent availability.
Tedesco Pharma / Other Regional Suppliers
- Several regional manufacturers produce povidrylex products, often catering to local markets with regulatory approvals.

B. Manufacturing and Quality Standards

Most leading suppliers comply with United States Pharmacopeia (USP) standards and adhere to Good Manufacturing Practices (GMP) to ensure product purity, stability, and safety.

II. Isopropyl Alcohol: Overview and Suppliers

Isopropyl alcohol (IPA) is a highly effective disinfectant, antiseptic, and solvent widely used in pharmaceutical, clinical, and industrial applications.

A. Premier Suppliers of Isopropyl Alcohol

Dow Chemical / Ineos
- Overview: Major global manufacturers with large-scale production facilities.
- Product Range: Offers high-purity IPA (IPA 99%) for pharmaceutical use.
- Distribution: Supplies to pharmaceutical companies, disinfectant producers, and industrial sectors.
Shell Chemicals
- Overview: Produces industrial and pharmaceutical-grade IPA.
- Market Presence: Supplies large volumes to global markets, ensuring continuous availability.
ExxonMobil
- Overview: Supplies high-volume IPA with pharmaceutical-grade certification.
- Quality Standards: Meets or exceeds USP and EP specifications for pharmaceutical use.
LyondellBasell
- Overview: Offers certified pharmaceutical-grade IPA, focusing on purity and consistent quality.
- Supply Capabilities: Robust manufacturing infrastructure supports global distribution.
Sinopec and CNPC
- Overview: Major Asian chemical producers offering competitive prices for IPA, with increasing focus on pharmaceutical-grade products.

B. Regulations and Quality Compliance

Suppliers adhere to GMP, USP, EP, and JP standards. Certificate of Analysis (CoA) and purity certifications are standard prerequisites for pharmaceutical-grade IPA procurement.

III. Regional and Market Considerations

Regional Suppliers: Local manufacturers can offer faster delivery times and customized formulations, especially in emerging markets.
Global Suppliers: Larger corporations provide a stable supply, consistent quality, and regulatory compliance but may have longer lead times.
Supply Chain Risks: Disruptions due to geopolitical issues, raw material shortages, or environmental factors impact availability. Diversifying supplier bases mitigates these risks.

IV. Procurement Strategies and Due Diligence

Verify Certifications: Ensure suppliers meet local and international regulatory standards.
Audit Manufacturing Sites: Regular audits guarantee quality compliance and prevent contamination risks.
Establish Contractual Agreements: Long-term contracts secure pricing stability and supply continuity.
Monitor Supply Chain Dynamics: Continuous market analysis helps anticipate capacity constraints or price fluctuations.

V. Conclusion

Iodine povacrylex and isopropyl alcohol are critical antiseptics with a broad supplier base comprising multinational corporations and regional manufacturers. Major players like 3M, Ecolab, Dow Chemical, Shell, and ExxonMobil dominate global supply chains with high-quality, GMP-compliant products. Strategic procurement involves balancing supplier reliability, regulatory adherence, and cost considerations.

Key Takeaways

Robust supplier relationships with well-regarded companies ensure supply stability for iodine povacrylex and isopropyl alcohol.
Regulatory compliance and quality certifications are critical in selecting suppliers for pharmaceutical-grade products.
Diversification mitigates risks associated with geopolitical disruptions, raw material shortages, or manufacturing issues.
Regional suppliers can provide logistical advantages but should meet international quality standards.
Continuous monitoring of market trends and supplier capacity is vital for maintaining supply chain resilience.

FAQs

1. Are there alternative suppliers for iodine povidrylex besides major international firms?
Yes. Regional manufacturers and generic pharmaceutical companies often produce povidrylex-based antiseptics, especially in Europe, Asia, and North America, provided they meet regulatory standards.

2. How do I verify if a supplier's isopropyl alcohol meets pharmaceutical standards?
Request Certificates of Analysis (CoA), GMP compliance documentation, and verify adherence to USP, EP, or JP specifications through independent testing if necessary.

3. What factors influence the choice of suppliers for these antiseptics?
Quality, regulatory certifications, supply capacity, cost, delivery reliability, and compliance with applicable standards influence procurement decisions.

4. How do geopolitical factors impact the supply of these drugs?
Trade restrictions, sanctions, or regional manufacturing disruptions can limit access or increase costs, emphasizing the importance of diversified sourcing.

5. Are there environmental or sustainability considerations required from suppliers?
Increasingly, companies require suppliers to adhere to environmental standards, such as reduced carbon footprint, responsible sourcing of raw materials, and sustainable manufacturing practices.

References

[1] U.S. Pharmacopeia. USP Monographs on Isopropyl Alcohol.
[2] European Pharmacopoeia. Specifications for Povidrylex formulations.
[3] 3M Healthcare. Product Data Sheets and Certifications.
[4] Ecolab. Infection Prevention Product Certifications.
[5] Industry Reports on Chemical Manufacturing Capacity, 2022.

Suppliers and packagers for generic pharmaceutical drug: iodine povacrylex; isopropyl alcohol