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

iodine povacrylex; isopropyl alcohol

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Solventum	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
Solventum	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

Pharmaceutical Supplier Analysis: Iodine Povacrylex and Isopropyl Alcohol

Last updated: February 19, 2026

This report analyzes the supplier landscape for Iodine Povacrylex and Isopropyl Alcohol, critical components in pharmaceutical manufacturing. The analysis focuses on identifying key manufacturers, regulatory compliance, supply chain risks, and pricing trends relevant to R&D and investment decisions.

What is Iodine Povacrylex?

Iodine Povacrylex is a polymer-based iodine complex used as a topical antiseptic. It is an iodophor, a compound that releases elemental iodine to exert antimicrobial activity. The polymer matrix provides a controlled release mechanism, potentially improving efficacy and reducing irritation compared to free iodine solutions.

Chemical Structure and Properties:

• Chemical Name: Poly(N-vinylpyrrolidone)-iodine
• CAS Number: 25655-41-8
• Appearance: Typically a light brown to reddish-brown powder or solution.
• Solubility: Soluble in water and polar organic solvents.
• Mechanism of Action: Releases free iodine which denatures proteins and oxidizes essential cellular components of microorganisms.
• Applications: Used in surgical scrubs, preoperative skin preparations, wound care, and disinfectants.

Regulatory Status: Iodine Povacrylex is regulated by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as an active pharmaceutical ingredient (API) or excipient. Manufacturers must adhere to Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.

Who Supplies Iodine Povacrylex?

The global supply of Iodine Povacrylex is concentrated among a limited number of specialized chemical manufacturers. These suppliers often produce other iodophors and iodine-based compounds.

Key Manufacturers and Suppliers:

• Ashland Global Holdings Inc.: A prominent supplier of specialty chemicals, including PVP-based products. They offer Povidone-Iodine (often referred to interchangeably in commercial contexts) under various trade names. Ashland's global manufacturing footprint allows for significant production capacity.
  • Product Offerings: Povidone-iodine solutions and powders suitable for pharmaceutical applications.
  • Regulatory Compliance: Ashland typically adheres to GMP standards and provides necessary documentation for regulatory submissions.
• BASF SE: A major chemical producer that manufactures polyvinylpyrrolidone (PVP) and its derivatives, including iodine complexes. BASF's extensive portfolio of excipients makes them a significant player in the pharmaceutical ingredients market.
  • Product Offerings: Kolliphor® P (a range of PVP and co-polymer grades).
  • Regulatory Compliance: BASF operates under strict quality management systems, including ISO and GMP certifications for relevant product lines.
• Shandong Luba Chemical Co., Ltd. (China): A Chinese manufacturer specializing in iodine-based chemicals and PVP. They serve both domestic and international markets.
  • Product Offerings: Povidone-Iodine API and intermediates.
  • Regulatory Compliance: Compliance with Chinese GMP standards is expected, with efforts to meet international pharmacopeial requirements.
• Telechemi (India): An Indian manufacturer producing a range of pharmaceutical intermediates and APIs, including povidone-iodine.
  • Product Offerings: Povidone-iodine IP/BP/USP grade.
  • Regulatory Compliance: Adherence to Indian GMP and pharmacopeial standards.

Supply Chain Considerations for Iodine Povacrylex:

• Raw Material Sourcing: The primary raw material is povidone, which is derived from vinylpyrrolidone. Iodine itself is another key raw material. The availability and price of these precursors can impact Iodine Povacrylex production costs.
• Geographic Concentration: A significant portion of Iodine Povacrylex production is concentrated in North America, Europe, and increasingly, Asia. This geographic concentration can present risks related to trade policies, natural disasters, and geopolitical instability.
• Quality Control: Stringent quality control is essential to ensure the purity, efficacy, and safety of Iodine Povacrylex for pharmaceutical use. Suppliers must provide Certificates of Analysis (CoA) and support Drug Master File (DMF) submissions.

What is Isopropyl Alcohol?

Isopropyl Alcohol (IPA), also known as isopropanol or 2-propanol, is a widely used solvent and disinfectant in the pharmaceutical industry. Its rapid evaporation and broad-spectrum antimicrobial activity make it indispensable for various applications.

Chemical Structure and Properties:

• Chemical Name: Isopropanol
• CAS Number: 67-63-0
• Formula: C3H8O
• Appearance: Colorless liquid with a characteristic odor.
• Solubility: Miscible with water, ethanol, and ether.
• Applications:
  • Solvent: For the extraction and purification of APIs, and in the formulation of topical solutions and ointments.
  • Disinfectant: Used for surface disinfection, skin antisepsis, and sterilization of medical equipment.
  • Cleaning Agent: For cleaning pharmaceutical manufacturing equipment.
  • Dehydrating Agent: In certain chemical synthesis processes.

Regulatory Status: Isopropyl Alcohol is generally recognized as safe (GRAS) for certain uses in food and pharmaceuticals by regulatory bodies like the FDA. However, pharmaceutical-grade IPA must meet stringent purity requirements as outlined in pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP).

Who Supplies Isopropyl Alcohol?

The market for Isopropyl Alcohol is highly competitive and characterized by a large number of global and regional producers. The primary production method involves the hydration of propylene, making it closely linked to the petrochemical industry.

Key Manufacturers and Suppliers:

• Dow Inc.: A major producer of chemicals and materials, including IPA. Dow operates large-scale production facilities globally.
  • Product Offerings: Various grades of IPA, including pharmaceutical grades meeting USP/EP standards.
  • Regulatory Compliance: Dow's pharmaceutical ingredients are manufactured under cGMP and other relevant quality systems.
• ExxonMobil Chemical: Another significant player in the petrochemical industry, producing IPA as a co-product or via direct synthesis.
  • Product Offerings: High-purity IPA for industrial and pharmaceutical applications.
  • Regulatory Compliance: Adherence to industry-specific quality standards.
• Ineos Group Holdings S.A.: A global manufacturer of petrochemicals, specialty chemicals, and oil products, with substantial IPA production capacity.
  • Product Offerings: IPA in bulk quantities and various purity grades.
  • Regulatory Compliance: Focus on consistent quality and adherence to international standards.
• LyondellBasell Industries N.V.: A major producer of polymers and chemicals, including IPA.
  • Product Offerings: USP/EP grade IPA.
  • Regulatory Compliance: Manufacturing sites often certified to ISO and GMP standards.
• Sinopec (China Petrochemical Corporation): A large state-owned energy and chemical company in China, with significant IPA production.
  • Product Offerings: IPA for industrial and pharmaceutical use.
  • Regulatory Compliance: Meeting Chinese national standards and pursuing international pharmacopeial compliance.
• Maruzen Petrochemical Co., Ltd. (Japan): A Japanese producer of basic petrochemicals and chemicals, including IPA.
  • Product Offerings: IPA meeting Japanese pharmacopeial standards.
  • Regulatory Compliance: Focus on quality and reliability for the Japanese market.

Supply Chain Considerations for Isopropyl Alcohol:

• Feedstock Availability: The price and availability of propylene, a key feedstock, directly influence IPA production costs. Propylene prices are subject to volatility in crude oil and natural gas markets.
• Logistics and Distribution: IPA is typically transported in bulk via rail, truck, and ship. Maintaining product integrity during transport is crucial, especially for pharmaceutical grades which may require specific containment.
• Global Capacity and Regional Supply: While IPA is widely produced, regional supply and demand dynamics can lead to localized shortages or price fluctuations. Geopolitical events and trade tariffs can also impact availability.
• Purity Requirements: Pharmaceutical manufacturers require IPA to meet extremely high purity standards to avoid contamination. Suppliers must demonstrate rigorous quality control and provide detailed certificates of analysis.

Pricing Trends and Market Dynamics

Iodine Povacrylex: The pricing for Iodine Povacrylex is influenced by the cost of raw materials (povidone and iodine), manufacturing complexity, and the volume purchased. As a specialty chemical with fewer primary producers compared to IPA, its price can be less volatile but may also reflect higher margins. Demand is driven by the pharmaceutical and medical device industries, particularly for antiseptic and disinfectant products.

• Price Range (Estimated per kg): \$20 - \$100+, depending on grade, purity, and volume.
• Factors Affecting Price:
  • Raw Material Costs: Fluctuations in povidone and iodine prices.
  • Regulatory Compliance: Costs associated with GMP manufacturing and documentation.
  • Supplier Concentration: Limited number of key suppliers can influence pricing power.
  • Volume Discounts: Significant discounts are typically available for bulk purchases.

Isopropyl Alcohol: IPA pricing is more directly tied to petrochemical market dynamics. As a large-volume commodity chemical, its price is subject to the fluctuations in propylene feedstock costs and global supply/demand balances. Pharmaceutical-grade IPA commands a premium over industrial grades due to stringent purity requirements and associated quality control measures.

• Price Range (Estimated per kg): \$1 - \$5+, depending on grade, purity, and volume.
• Factors Affecting Price:
  • Propylene Feedstock Costs: Primary driver of production costs.
  • Energy Prices: Affects production and transportation costs.
  • Global Supply and Demand: Production capacity versus consumption by various industries.
  • Purity Standards: Pharmaceutical grades (USP/EP) are more expensive than industrial grades.
  • Logistics: Transportation costs can be significant due to the nature of bulk liquid transport.

Supply Chain Risk Assessment

Iodine Povacrylex:

• Supply Concentration Risk: Dependence on a few key global manufacturers presents a significant risk. Disruptions at a single facility due to natural disasters, accidents, or geopolitical issues can lead to shortages.
• Raw Material Volatility: While less volatile than IPA, disruptions in the supply of povidone or iodine can impact Iodine Povacrylex availability and price.
• Regulatory Hurdles: Changes in regulatory requirements or import/export restrictions can affect supply chains.
• Quality Assurance: Ensuring consistent quality across different suppliers and batches is paramount. Supplier audits and robust quality agreements are essential.

Isopropyl Alcohol:

• Feedstock Price Volatility: Fluctuations in crude oil and natural gas prices can lead to unpredictable IPA pricing, impacting R&D and manufacturing budgets.
• Logistics Disruptions: Global shipping and transportation challenges, including port congestion and driver shortages, can affect timely delivery.
• Geopolitical Factors: Trade disputes, sanctions, and regional conflicts can disrupt global IPA trade flows.
• Environmental Regulations: Increasing environmental scrutiny on chemical production may influence manufacturing costs and practices.

Key Takeaways

• The supply of Iodine Povacrylex is concentrated among a smaller number of specialty chemical manufacturers, requiring robust supplier relationship management and contingency planning.
• Isopropyl Alcohol is a widely available commodity chemical with a more fragmented supplier base, but its pricing is susceptible to petrochemical market volatility.
• Pharmaceutical-grade requirements for both Iodine Povacrylex and Isopropyl Alcohol necessitate stringent quality control, GMP compliance, and comprehensive documentation from suppliers.
• Supply chain risks for both materials include raw material availability, geopolitical factors, logistics, and regulatory changes. Diversification of suppliers and proactive risk mitigation strategies are critical for ensuring uninterrupted supply.
• Companies should establish strong quality agreements with suppliers and consider dual sourcing for critical raw materials to mitigate supply chain disruptions.

Frequently Asked Questions

1. What is the typical lead time for sourcing pharmaceutical-grade Isopropyl Alcohol in bulk quantities? Lead times can vary significantly based on supplier inventory, current market demand, and transportation logistics, but typically range from 2 to 8 weeks for established contracts.

2. Are there any specific challenges in ensuring the stability of Iodine Povacrylex during storage and transport? Iodine Povacrylex can be sensitive to light, heat, and moisture. Suppliers must provide appropriate packaging and storage recommendations, and transport conditions should be controlled to prevent degradation.

3. How do U.S. FDA regulations impact the sourcing of Iodine Povacrylex? The FDA requires all active pharmaceutical ingredients (APIs) and critical excipients to be manufactured under Current Good Manufacturing Practices (cGMP). Suppliers must be able to provide evidence of compliance, often through facility audits and Drug Master File (DMF) submissions.

4. What are the primary alternatives to Isopropyl Alcohol for surface disinfection in pharmaceutical cleanrooms? Common alternatives include ethanol (ethyl alcohol), peracetic acid, and quaternary ammonium compounds, each with different efficacy profiles and compatibility with various surfaces and materials.

5. Can suppliers of Iodine Povacrylex also provide technical support for formulation development? Many specialty chemical suppliers, particularly larger ones like Ashland and BASF, offer technical support services that can assist with formulation challenges, regulatory inquiries, and product application guidance.

Citations

[1] Ashland Global Holdings Inc. (n.d.). Povidone & Copovidone. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [2] BASF SE. (n.d.). Kolliphor® P. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [3] Shandong Luba Chemical Co., Ltd. (n.d.). Povidone Iodine. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [4] Telechemi. (n.d.). Povidone Iodine. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [5] Dow Inc. (n.d.). Isopropyl Alcohol. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [6] ExxonMobil Chemical. (n.d.). Isopropyl Alcohol. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [7] Ineos Group Holdings S.A. (n.d.). Isopropyl Alcohol. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [8] LyondellBasell Industries N.V. (n.d.). Isopropyl Alcohol. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [9] Sinopec. (n.d.). Isopropyl Alcohol. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering) [10] Maruzen Petrochemical Co., Ltd. (n.d.). Isopropyl Alcohol. Retrieved from [Supplier Website] (Specific URL omitted for generality as product specifics vary by region and offering)