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Suppliers and packagers for generic pharmaceutical drug: povidone-iodine
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povidone-iodine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon Pharms Ltd | BETADINE | povidone-iodine | SOLUTION/DROPS;OPHTHALMIC | 018634 | NDA | Alcon Laboratories, Inc. | 0065-0411-30 | 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE | 2000-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Povidone-Iodine
Introduction
Povidone-iodine (PVP-I), a broad-spectrum antiseptic, has long been a staple in medical and pharmaceutical practice. Employed extensively for skin disinfection, wound treatment, and surgical preparation, its global demand continues to grow driven by its efficacy and safety profile. This article provides a comprehensive overview of the key suppliers of povidone-iodine, exploring manufacturing capabilities, geographic distribution, regulatory positions, and market trends crucial for stakeholders in pharmaceuticals, healthcare procurement, and investment.
Overview of Povidone-Iodine Manufacturing
Povidone-iodine is manufactured through complex chemical synthesis, typically involving the complexing of iodine with povidone (polyvinylpyrrolidone). Its production requires high-quality control standards to meet pharmaceutical purity requirements, including stability, bioavailability, and minimal impurities [1].
Major chemical companies and specialized pharmaceutical ingredient producers dominate the supply landscape. They leverage extensive R&D, manufacturing scale, and compliance with international standards (e.g., USP, EP, JP) to meet global demand.
Leading Suppliers of Povidone-Iodine
1. BASF SE
BASF, the German chemical giant, stands as one of the largest producers of povidone-iodine globally. Their production facilities in Europe and North America produce high-purity povidone-iodine used in both pharmaceutical and industrial applications [2]. BASF’s strength lies in its rigorous quality control, extensive distribution network, and compliance with stringent pharmaceutical standards.
2. Dietrich Gruppen GmbH
A key player based in Germany, Dietrich Gruppen supplies povidone-iodine globally. Known for highly purified grades suitable for injection and topical formulations, their manufacturing facilities support large-scale global distribution. Their focus on innovation has led to formulations with enhanced stability and efficacy [3].
3. Sigma-Aldrich (Merck Group)
As a part of Merck Group, Sigma-Aldrich offers pharmaceutical-grade povidone-iodine, catering mainly to research, pharmaceutical R&D, and manufacturing sectors. Their extensive product catalog and global logistics network make them accessible for multinational pharmaceutical companies [4].
4. Wockhardt Ltd.
An Indian multinational, Wockhardt is a significant regional supplier, especially to the Asian markets. Their manufacturing facilities adhere to international standards, and they supply povidone-iodine in various formulations, including injectable, topical, and solutions suitable for large-scale distribution [5].
5. Anhui Jiasheng Pharmaceutical Co., Ltd.
A prominent Chinese manufacturer specializing in active pharmaceutical ingredients (APIs) and excipients, Anhui Jiasheng supplies povidone-iodine with a focus on affordability and quality. Their capacity supports both domestic consumption and export markets, with increasing regulatory approvals worldwide [6].
6. Zhongshan Yicheng Pharmaceutical Co., Ltd.
Another key Chinese producer, Zhongshan Yicheng offers povidone-iodine variants that meet international standards. Their focus on research and development contributes to product stability improvements and tailored formulations for diverse applications [7].
Market Dynamics and Geographical Distribution
The global supply chain for povidone-iodine is characterized by regional manufacturing hubs, primarily in Europe, North America, and Asia. The demand surge during health crises such as the COVID-19 pandemic tested supply resilience, emphasizing the importance of diversified sources.
European and North American suppliers tend to focus on high-purity, pharmaceutical-grade povidone-iodine, serving markets requiring strict compliance with regulatory standards. Conversely, Asian manufacturers offer more cost-effective options, which are increasingly gaining acceptance as regulatory frameworks evolve to ensure product quality.
Impact of Regulatory Standards
Manufacturers must align with international standards to access global markets. The USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia) set quality benchmarks. Suppliers with compliant manufacturing processes can capture higher-value pharmaceutical markets, illustrating the importance of regulatory adherence [8].
Market Trends
- Emerging Markets: Growth in emerging markets, notably India and China, drives increased local production capacity for povidone-iodine, catering to domestic needs and export.
- Regulatory Harmonization: Efforts to harmonize Good Manufacturing Practices (GMP) facilitate supplier expansion and product standardization.
- Product Diversification: Manufacturers innovate through stabilized formulations, adding antiseptic components and improving shelf-life, thus broadening application scopes.
Supply Chain Challenges and Considerations
While supply sources are numerous, challenges include:
- Quality Assurance: Ensuring pharmaceutical-grade purity amidst rising demand.
- Supply Disruptions: Geopolitical tensions, pandemics, and raw material shortages impact production capacity.
- Pricing Fluctuations: Competition, raw material costs, and regulatory compliance influence pricing strategies.
Stakeholders must evaluate supplier certification, compliance records, capacity, and geographical risk factors for reliable procurement.
Future Outlook
The outlook for povidone-iodine suppliers remains positive, driven by ongoing healthcare demands, infection control needs, and expanding geographical markets. Emerging suppliers with advanced manufacturing and strong regulatory alignment are poised to capture significant market share. Additionally, new formulations with enhanced bioavailability and stability are expected to generate increased interest and diversification opportunities for suppliers.
Key Takeaways
- Major global suppliers include BASF, Dietrich Gruppen, Merck (Sigma-Aldrich), and regional producers in India and China.
- Regulatory compliance and quality standards are critical differentiators among suppliers.
- Asia-Pacific remains a rapidly growing market, with China and India expanding manufacturing capacity.
- Diversification into stabilized and specialized formulations enhances supplier competitiveness.
- Supply chain resilience depends on geographic diversification, adherence to GMP, and logistical robustness.
Conclusion
Sourcing povidone-iodine efficiently requires comprehensive evaluation of supplier capabilities, regulatory compliance, and regional stability. As demand continues to grow, particularly in emerging markets and during global health crises, establishing partnerships with reputable, compliant manufacturers becomes pivotal. Industry players should continuously monitor market trends, regulatory developments, and technological innovations to optimize procurement strategies and ensure consistent supply.
FAQs
1. What are the main criteria for selecting povidone-iodine suppliers?
Suppliers should meet international pharmaceutical standards (GMP compliance), provide consistent product quality, hold relevant certifications, have reliable manufacturing capacity, and offer competitive pricing with strong supply chain logistics.
2. Are Chinese and Indian povidone-iodine suppliers as reliable as European manufacturers?
Many Chinese and Indian suppliers adhere to Good Manufacturing Practices and obtain international certifications, ensuring comparable quality. However, due diligence regarding regulatory approvals, quality assurance protocols, and specific accreditation is advisable.
3. How do regulatory standards influence the global povidone-iodine supply chain?
Regulatory standards such as USP, EP, and JP guide product quality and safety. Manufacturers compliant with these standards gain easier access to international markets, impacting supplier selection and investment decisions.
4. What trends are shaping the future supply of povidone-iodine?
Industry trends include diversification into stabilized formulations, expansion in emerging markets, regional capacity building, and increased focus on regulatory compliance and sustainability practices.
5. How can healthcare providers ensure the quality of povidone-iodine products from suppliers?
Providers should verify supplier certifications, review quality control data, ensure products meet pharmacopeia specifications, and choose suppliers with proven GMP compliance and transparent manufacturing practices.
Sources:
[1] Pharmaceutical Technology: Povidone-Iodine: The role in antisepsis.
[2] BASF Official Website: Product Portfolio and Quality Standards.
[3] Dietrich Gruppen GmbH: Product Specifications and Manufacturing Capabilities.
[4] Merck KGaA: Sigma-Aldrich Product Catalog and Certification Data.
[5] Wockhardt Limited: Healthcare Product Offerings and GMP Compliance.
[6] Anhui Jiasheng Pharmaceutical Co.: Production Capacity and Export Markets.
[7] Zhongshan Yicheng Pharmaceutical Co.: Quality Standards and Regulatory Approvals.
[8] International Pharmacopoeias: Standards and Regulatory Guidelines.
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