Share This Page
Suppliers and packagers for nithiodote
✉ Email this page to a colleague
nithiodote
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444 | NDA | Hope Pharmaceuticals | 60267-812-00 | 1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50) | 2011-01-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nithiodote
Introduction
Nithiodote is a clinical formulation that combines sodium thiosulfate and ethanol in a proprietary preparation, primarily utilized as an antidote in cases of cyanide poisoning. Its unique formulation plays a critical role in emergency medicine, prompting the need for reliable suppliers to ensure its availability across healthcare facilities globally. This analysis provides an in-depth overview of key suppliers involved in the manufacturing and distribution of Nithiodote, examines their market positions, and explores implications for stakeholders.
Product Overview: Nithiodote
Nithiodote is formulated as a sterile injectable solution intended for rapid administration by healthcare professionals. Its efficacy hinges on the availability of high-quality raw ingredients, manufacturing excellence, and a robust supply chain. Due to its vital status in acute care settings, the supply landscape involves specialized pharmaceutical companies capable of complying with stringent regulatory standards.
Manufacturers and Suppliers of Nithiodote
Currently, Nithiodote is primarily produced by Cumberland Pharmaceuticals, a global specialty pharmaceutical company headquartered in Nashville, Tennessee. They have developed proprietary formulations and hold licensing agreements to distribute the medication within various markets. Following acquisition and licensing, several regional and third-party suppliers have become involved in its distribution.
1. Cumberland Pharmaceuticals
Manufacturer and Primary Supplier
Cumberland Pharmaceuticals is recognized as the sole approved manufacturer of Nithiodote in the United States. Established in 1993, Cumberland specializes in developing and marketing hospital-based therapies, with Nithiodote being a flagship product within their antidote portfolio. The company operates FDA-approved manufacturing facilities adhering to Good Manufacturing Practices (GMP), ensuring the drug's safety, efficacy, and quality.
Supply Chain and Distribution
Cumberland maintains a comprehensive distribution network across North America and selected international markets. They partner with authorized distributors capable of handling sensitive, sterile injectables. The company also emphasizes maintaining strategic stockpiles to meet emergency demands and mitigate shortages.
2. Contract Manufacturing Organizations (CMOs)
While Cumberland is the licensed manufacturer, third-party CMOs often support large-scale production, especially for bulk raw materials or component synthesis. These include pharmaceutical CDMOs with capabilities in sterile manufacturing under GMP standards.
Implication for Suppliers
The involvement of CMOs introduces a layered supply chain, which may affect availability and lead times. Suppliers need to ensure their adherence to compliance standards andquality assurance protocols.
3. Raw Material Suppliers
The production of Nithiodote depends critically on high-purity raw materials such as sodium thiosulfate and ethanol. These materials are sourced from specialized ingredient suppliers that meet pharmacopeial standards.
- Sodium Thiosulfate: Some of the key raw material vendors include Fisher Scientific, Sigma-Aldrich (Merck), and other certified chemical suppliers. These companies supply pharmaceutical-grade sodium thiosulfate with certificates of analysis (CoA) complying with USP or EP standards.
- Ethanol: High-purity ethanol is procured from suppliers like GreenField Ethanol or similar providers that comply with FDA and WHO standards for medical use.
Supply Considerations
The reliance on bulk chemical suppliers emphasizes the importance of supply chain resilience, especially amid global disruptions like pandemics or raw material shortages.
Global and Regional Distribution Channels
Although Cumberland Pharmaceuticals dominates in the US market, international distribution involves partnerships with regional pharmaceutical distributors and importers. For example, in Europe, licensing agreements with local firms such as Bristol-Myers Squibb or Novartis facilitate market penetration, though specific licensing of Nithiodote may vary.
Regulatory Approvals and Licensing
In addition to manufacturing, distribution hinges on obtaining necessary regulatory approvals from agencies like the FDA (US), EMA (Europe), and other regional authorities. These approvals serve as key indicators of compliant supply pathways.
Market Dynamics and Challenges
Supply Stability
An emerging concern is the limited number of suppliers. Given Nithiodote's specialized nature, fragmentation in the supply chain could lead to shortages, especially during high-demand periods such as natural disasters or industrial accidents.
Regulatory and Quality Compliance
Suppliers must navigate complex regulatory environments, requiring strict compliance with GMP, pharmacovigilance, and serialization standards. Any deviation may jeopardize supply continuity.
Pricing and Accessibility
Pricing strategies and reimbursement policies influence supplier participation and market penetration. Manufacturers, such as Cumberland, often set premium prices for scarcity-driven products, impacting procurement processes for healthcare providers.
Future Outlook and Strategic Considerations
- Expansion of Manufacturer Base: Increasing the number of licensed manufacturers or licensed production facilities can enhance supply resilience.
- Development of Alternate Formulations: Research into stable, lyophilized or more easily transportable formulations may diversify supply options.
- Supply Chain Diversification: Collaborating with multiple raw material suppliers and establishing regional manufacturing hubs can reduce vulnerabilities.
Key Takeaways
- Cumberland Pharmaceuticals is the primary and most recognized manufacturer/supplier of Nithiodote, with an extensive distribution network primarily in the US.
- Raw material procurement from reputable chemical suppliers such as Sigma-Aldrich and Fisher Scientific ensures high-quality ingredients critical to manufacturing.
- Dependence on a limited number of suppliers and complex supply chains pose risks of shortages; diversifying manufacturing partnerships is essential.
- Regulatory compliance and quality assurance are crucial for maintaining supply stability across regions.
- Strategic stockpiles, regional manufacturing, and licensing agreements are vital tools to improve global availability.
FAQs
1. Who is the main manufacturer of Nithiodote?
Cumberland Pharmaceuticals holds the license and primarily produces Nithiodote, supplying it mainly within the US market.
2. What raw materials are used in Nithiodote, and who supplies them?
The key raw materials are sodium thiosulfate and ethanol, supplied by chemical suppliers like Sigma-Aldrich and Fisher Scientific, meeting pharmaceutical standards.
3. Are there alternative suppliers or manufacturers for Nithiodote globally?
Currently, Nithiodote’s manufacturing rights are concentrated with Cumberland. However, licensing agreements with regional partners might exist, though detailed information is limited.
4. How secure is the supply chain for Nithiodote?
The supply chain's security depends on manufacturing capacity, raw material availability, and regulatory factors. Limited manufacturer diversification poses potential risks.
5. What strategies could improve Nithiodote’s supply resilience?
Establishing additional licensed manufacturing facilities, diversifying raw material sources, and developing alternative formulations can bolster supply stability.
References
[1] Cumberland Pharmaceuticals. Nithiodote Product Information.
[2] U.S. Food and Drug Administration. Approved Drug Products.
[3] Sigma-Aldrich. Pharmaceutical-grade sodium thiosulfate specifications.
[4] Manufacturer regulatory compliance standards.
[5] Global pharmaceutical supply chain reports, 2022.
More… ↓
