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Suppliers and packagers for generic pharmaceutical drug: INDIGOTINDISULFONATE SODIUM
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INDIGOTINDISULFONATE SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Provepharm Sas | BLUDIGO | indigotindisulfonate sodium | SOLUTION;INTRAVENOUS | 216264 | NDA | Provepharm Inc. | 81284-315-05 | 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00) | 2022-09-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: INDIGOTINDISULFONATE SODIUM
Introduction
Indigotindisulfonate sodium, commonly known by its brand name, Indigo Carmine, is a synthetic dye utilized in various pharmaceutical and diagnostic applications. Its primary functions include serving as a visualizing agent in medical imaging procedures and as a dye for surgical and diagnostic interventions. As a pharmaceutical ingredient, its supply chain is characterized by specialized manufacturers, regulatory oversight, and a global network of suppliers.
This article analyzes current suppliers for indigotindisulfonate sodium, examining manufacturing landscape, regulatory factors, and strategic supply considerations pertinent to pharmaceutical companies and healthcare providers seeking procurement options.
Manufacturers and Key Suppliers
Global Pharmaceutical and Chemical Manufacturers
The supply of indigotindisulfonate sodium is concentrated among a handful of chemical and pharmaceutical manufacturers with expertise in dye synthesis and pharmaceutical-grade chemicals.
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BASF SE (Germany): A leading global chemical producer, BASF is among the principal suppliers of synthetic dyes, including indigotindisulfonate sodium, primarily catering to pharmaceutical and diagnostic sectors. Their products adhere to stringent quality standards, such as USP, EP, and Ph. Eur. specifications, ensuring suitability for medical use.
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Dalian Meilong Chemical Co., Ltd. (China): A prominent manufacturer of dyes and intermediates, offering indigotindisulfonate sodium with focus on bulk chemical stability and cost efficiency. Their products are widely distributed across Asia and exported internationally.
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Sigma-Aldrich / Merck KGaA (Germany): A major supplier of research chemicals, Sigma-Aldrich offers indigotindisulfonate sodium for laboratory and clinical research, providing pharmaceutical-grade products compliant with regulatory standards.
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Jiangsu Yabang Dyes Co., Ltd. (China): Specialized in dyes used in the medical sector, this manufacturer supplies indigotindisulfonate sodium to global markets with certifications suitable for pharmaceutical manufacturing.
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Tianjin Yongda Chemical Co., Ltd. (China): Focused on specialty chemicals, including diagnostic dyes, providing indigotindisulfonate sodium in large-scale quantities for hospital and manufacturing use.
Market Dynamics and Supplier Capabilities
While numerous regional producers exist, the key to pharmaceutical procurement lies in regulatory compliance, product purity, and supply stability. Leading suppliers typically possess approvals from major pharmacopoeias such as USP and EP, ensuring their products meet clinical application standards.
The capacity of these manufacturers varies, with larger firms like BASF able to supply bulk quantities with consistent quality, while smaller regional suppliers often cater to niche markets or research-grade needs.
Regulatory and Certification Considerations
Strict regulatory frameworks govern pharmaceutical ingredients, emphasizing Good Manufacturing Practices (GMP), safety, and efficacy. Suppliers must maintain certifications such as:
- FDA registration (for US markets)
- EDQM certification (European Directorate for the Quality of Medicines & HealthCare)
- ISO 9001/ISO 13485 standards
For procurement, verifying adherence to these standards is fundamental.
Emerging Suppliers and Market Trends
Recent trends indicate the emergence of Chinese and Indian manufacturers entering the global market, driven by cost competitiveness and expanding regional capacities. However, pharmaceutical companies often conduct rigorous qualification processes to verify the quality and regulatory compliance of such suppliers.
Additionally, the increasing demand for diagnostic dyes post-pandemic has encouraged manufacturers to expand production capacities, diversify sourcing options, and optimize supply chain resilience.
Strategic Sourcing and Procurement Considerations
- Quality Assurance: Prioritize suppliers with established regulatory compliance, consistent product grades (USP, EP), and documented quality control processes.
- Supply Stability: Engage suppliers with proven manufacturing capacity and supply chain robustness, especially in the face of geopolitical or logistical disruptions.
- Pricing & Contracts: Establish long-term agreements with reliable suppliers to mitigate price fluctuations and secure priority access during shortages.
- Regulatory Support: Choose suppliers providing comprehensive documentation, regulatory filings, and technical support.
Conclusion
The procurement of indigotindisulfonate sodium involves a select group of global suppliers distinguished by their manufacturing capacity, regulatory compliance, and product quality. Key providers such as BASF, Merck, and Chinese chemical producers dominate the supply landscape, each bringing different capabilities to the table.
Supply chain stability hinges on rigorous supplier qualification, adherence to global quality standards, and strategic contracting. As demand for diagnostic and pharmaceutical dyes grows, especially in emerging markets, diversifying suppliers and maintaining oversight becomes critical for healthcare organizations and pharmaceutical manufacturers.
Key Takeaways
- Major Suppliers: BASF, Merck (Sigma-Aldrich), and several Chinese manufacturers are the primary suppliers of pharmaceutical-grade indigotindisulfonate sodium.
- Regulatory Compliance: Suppliers must meet stringent quality standards, including USP, EP, and GMP compliance.
- Supply Chain Resilience: Establish long-term relationships with diversified suppliers to mitigate risks associated with shortages or geopolitical disruptions.
- Emerging Markets: China and India are expanding capacities, offering cost advantages but require thorough quality validation.
- Procurement Strategy: Prioritize quality assurance, regulatory compliance, and supply stability over cost to ensure consistent pharmaceutical application.
FAQs
1. What are the main manufacturing regions for indigotindisulfonate sodium?
The primary manufacturing regions include Europe (notably Germany via BASF), China, and India. These regions host key producers capable of supplying pharmaceutical-grade products globally.
2. Are all suppliers compliant with international regulatory standards?
No. Only leading suppliers such as BASF and Merck typically possess comprehensive certifications like GMP, USP, and EP. Regional manufacturers may vary in compliance, necessitating due diligence before procurement.
3. What factors influence the choice of supplier for indigotindisulfonate sodium?
Quality standards, regulatory compliance, supply capacity, lead times, cost, and supplier reputation are critical considerations in selecting a supplier.
4. Can indigotindisulfonate sodium be sourced from research chemical suppliers for clinical uses?
Yes, research-grade products from suppliers like Sigma-Aldrich are available. However, for clinical or pharmaceutical applications, sourcing from suppliers with pharmaceutical-grade certifications is essential.
5. How is supply chain risk managed for such specialized chemical ingredients?
By establishing multi-source procurement strategies, maintaining safety stocks, verifying supplier certifications, and engaging with suppliers who demonstrate consistent quality and supply capacity.
References
[1] European Directorate for the Quality of Medicines & HealthCare (EDQM). Pharmacopoeia standards.
[2] U.S. Pharmacopeia (USP). Monographs on dyes and diagnostic agents.
[3] BASF SE. Product catalog and regulatory compliance documentation.
[4] Merck KGaA. Sigma-Aldrich product data sheets and regulatory info.
[5] Industry market reports on pharmaceutical dye manufacturing and supply chain analysis.
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