Share This Page
Suppliers and packagers for generic pharmaceutical drug: indigotindisulfonate sodium
✉ Email this page to a colleague
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 |
Indigotindisulfonate Sodium: A Comprehensive Analysis of Global Suppliers and Regulatory Landscape
Indigotindisulfonate sodium, commonly known as indigo carmine, is a diagnostic dye with critical applications in surgical and clinical settings. This synthetic compound, recognized for its vivid blue color, is utilized intraoperatively to assess ureteral integrity during abdominal and pelvic surgeries[4][8]. Its role extends beyond medicine, serving as a food additive (E132) and pH indicator[2][6]. The global supply chain for this pharmaceutical ingredient involves a network of manufacturers and suppliers adhering to stringent regulatory standards. This report examines the key players, regulatory frameworks, pricing dynamics, and market trends shaping the availability of indigotindisulfonate sodium.
Chemical and Pharmacological Profile of Indigotindisulfonate Sodium
Molecular Structure and Properties
Indigotindisulfonate sodium (CAS 860-22-0) is an organic sodium salt derived from the condensation of indigo carmine’s acid form with sodium hydroxide. Its molecular formula, ( \text{C}_{16}\text{H}_8\text{N}_2\text{Na}_2\text{O}_8\text{S}_2 ), confers water solubility while remaining insoluble in most organic solvents[2][7]. The compound’s planar structure enables its function as a redox indicator, transitioning between blue (oxidized) and yellow (reduced) states at pH 11.5–14[6].
Clinical Applications
Approved by the U.S. Food and Drug Administration (FDA) in 2022, BLUDIGO™ (Provepharm’s indigotindisulfonate sodium injection) revolutionized intraoperative visualization during urological and gynecological procedures[4][8]. By highlighting urinary tract structures, it reduces intraoperative injury risks, underscoring its diagnostic indispensability. Off-label uses include renal function assessments and endoscopic screenings[9][12].
Global Manufacturing Landscape
Key Suppliers and Geographic Distribution
The production of indigotindisulfonate sodium is concentrated in Asia, with India and China dominating the market. Biophore India Pharmaceuticals Pvt Ltd and Macsen Labs lead Indian exports, leveraging WHO-GMP and U.S. FDA certifications to supply high-purity APIs[1][3]. Sichuan Xieli Pharmaceutical and Sekisui Medical Co. Ltd represent China and Japan, respectively, emphasizing cost-effective synthesis and scalability[1][3]. European participation is exemplified by Provepharm, which combines French formulation expertise with U.S. regulatory compliance to distribute BLUDIGO™ globally[4][8].
Regulatory Certifications
- U.S. Drug Master File (USDMF): Macsen Labs and Azico Biophore maintain active USDMFs, ensuring adherence to FDA’s Current Good Manufacturing Practices (cGMP)[1][3].
- European CEP/COS: Dishman Carbogen Amcis holds Certificates of Suitability, facilitating EU market access[1][13].
- Japan’s JDMF: Sekisui Medical complies with Japanese Pharmacopeia standards, catering to Asia-Pacific demand[1][3].
Regulatory Compliance and Quality Assurance
FDA Oversight and Approvals
The FDA’s 2022 endorsement of BLUDIGO™ marked a pivotal moment, validating Provepharm’s R&D investments and reinforcing indigotindisulfonate sodium’s safety profile[4][8]. Manufacturers must submit detailed DMFs, undergo pre-approval inspections, and implement continuous quality monitoring to mitigate risks like endotoxin contamination[13].
Pharmacopeial Standards
Compliance with U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP) monographs is mandatory. For instance, USP-grade material must exhibit ≤0.5% sulfated ash and meet stringent heavy-metal limits[7][13]. Macsen Labs exemplifies this through ISO 9001-certified audits and batch-specific Certificates of Analysis (CoA)[2][3].
Pricing Dynamics and Market Influences
Cost Determinants
Indigotindisulfonate sodium prices fluctuate based on raw material availability (e.g., aniline derivatives), geopolitical trade policies, and regulatory updates. Indian suppliers like Ataman Kimya offer competitive rates (~$200/kg), while U.S.-aligned producers charge premiums (~$450/kg) for cGMP-compliant batches[1][3].
Supply Chain Vulnerabilities
The 2020–2025 period saw intermittent shortages due to COVID-19-related logistics disruptions and increased surgical demand post-pandemic. American Regent addressed this via strategic stockpiling, offering 5 mL ampules (8 mg/mL) for intramuscular/intravenous use[12].
Emerging Trends and Future Outlook
Biosynthetic Alternatives
Research into microbial indigo production (e.g., E. coli expressing tryptophanase) promises eco-friendly synthesis, potentially reducing reliance on petrochemical precursors[6][9]. Korea Biochem Pharm is piloting fermentation-based methods, aiming for commercial-scale output by 2026[3].
Regulatory Harmonization
The International Council for Harmonisation (ICH) Q12 guidelines are streamlining post-approval changes across markets, enabling suppliers like Dishman Carbogen Amcis to expedite global distribution[1][13].
Strategic Recommendations for Stakeholders
- Diversify Sourcing: Engage multi-regional suppliers (e.g., Macsen Labs, Sichuan Xieli) to mitigate geopolitical risks.
- Invest in QA/QC: Adopt real-time release testing (RTRT) to align with FDA’s emerging guidelines.
- Monitor Patent Expiries: Provepharm’s BLUDIGO™ patent expires in 2032, opening opportunities for generics[4][8].
Key Takeaways
- Indigotindisulfonate sodium is essential for surgical diagnostics, with Provepharm’s BLUDIGO™ leading FDA-approved products.
- Indian and Chinese manufacturers dominate supply, supported by USDMF and CEP certifications.
- Pricing volatility necessitates agile procurement strategies.
FAQs
- Is indigo carmine FDA-approved?
Yes, as BLUDIGO™ for ureteral visualization[4][8]. - What distinguishes USP-grade material?
Compliance with U.S. Pharmacopeia purity and testing criteria[7][13]. - Which suppliers offer WHO-GMP-certified APIs?
Macsen Labs and Biophore India[2][3]. - How does indigo carmine function intraoperatively?
It binds to urinary tract tissues, enhancing endoscopic visibility[9][12]. - What drives indigotindisulfonate sodium’s cost?
Raw material costs, regulatory compliance, and geopolitical factors[1][3].
“BLUDIGO™’s approval underscores Provepharm’s commitment to addressing unmet surgical needs through innovative diagnostics.” — Frederick Girard, Provepharm CMO[4].
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/indigotindisulfonate-sodium
- https://www.macsenlab.com/active-pharmaceutical-ingredients/indigo-carmine-usp-860-22-0/
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/indigotindisulfonate-sodium-usp
- https://www.provepharm.com/en/actualites/provepharm-receives-fda-marketing-approval-us-bludigo-its-indigo-carmine-injection-drug
- https://www.macsenlab.com/blog/what-is-indigo-carmine/
- https://www.chemscene.com/860-22-0.html?productObj=CS-W020966
- https://emeraldscientific.com/indigotindisulfonate-sodium-750mg/
- https://www.us.provepharm.com/node/135
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/indigotindisulfonic-acid
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/indigo+carmine
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/indigotindisulfonate
- https://allmedtech2.com/products/indigo-carmine-kidney-funtion-and-localization-indigotindisulfonate-sodium-preservative-free-08-8-mg-ml-intramuscular-or-intravenous-injection-ampule-5-ml-5pack-american-regent-00517037505
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/indigotindisulfonate-sodium
More… ↓
