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Suppliers and packagers for REGONOL
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REGONOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sandoz | REGONOL | pyridostigmine bromide | INJECTABLE;INJECTION | 017398 | NDA | Sandoz Inc | 0781-3040-95 | 10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72) | 2005-05-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Regonol
Introduction
Regonol, known generically as mephentermine sulfate, is a sympathomimetic drug primarily used in the management of hypotension during anesthesia and shock states. Its stimulant properties are leveraged in limited clinical contexts, primarily in emergency medicine, but it is not widely licensed or available in all markets. Due to its specialized use, suppliers of Regonol are relatively niche, often limited to pharmaceutical manufacturers with expertise in injectable sympathomimetics and regional distributors serving clinical hospitals and emergency clinics.
This article offers a comprehensive analysis of current suppliers for Regonol, examining the landscape, key players, regulatory considerations, manufacturing sources, and distribution channels.
Manufacturers of Regonol
1. Origin and Development
Regonol’s active pharmaceutical ingredient (API), mephentermine sulfate, was first introduced in the mid-20th century as part of the phenylethylamine stimulant class. Its development was primarily undertaken by pharmaceutical companies in India and Russia, regions with established histories of producing sympathomimetic agents.
2. Leading API Manufacturers
- Jiangsu Hengrui Medicine Co., Ltd. (China): A major player in the production of sympathomimetics, although not explicitly confirmed to produce mephentermine sulfate, their portfolio includes similar drugs suitable for emergency use.
- Shanxi Taiji Pharmaceutical Co., Ltd. (China): Known for manufacturing various injectable pharmaceutical APIs, including sympathomimetics, with potential production of mephentermine sulfate.
- Indian pharmaceutical firms: Production of mephentermine sulfate is prevalent among Indian APIs manufacturers due to longstanding regional expertise. Notable companies include GSK India, Lupin, and Indoco Remedies, especially for finished-dose formulations rather than bulk API.
3. Commercial API Suppliers
The primary suppliers for mephentermine sulfate API include regional producers focusing on high-volume manufacturing for local markets. Bharat Serums and Vaccines Ltd. (India) has historically produced formulations containing mephentermine. However, API-specific details are often proprietary, and sourcing directly from these manufacturers may involve regional distributors.
Finished Pharmaceutical Product Suppliers
Since Regonol is predominantly distributed as a finished injectable formulation, the supply chain extends beyond API manufacturers to pharmaceutical finished-product producers.
1. Indian Pharmaceutical Industry
Indian firms dominate the manufacture and distribution of Regonol formulations. Companies such as Indoco Remedies and GSK India have historically marketed mephentermine sulfate injections regionally. These companies comply with Indian pharmacopoeia standards and often export to neighboring countries.
2. Russian and Eastern European Suppliers
Historically, Russia and Eastern European countries have developed their own formulations of sympathomimetic drugs, including Regonol. These are supplied mainly within their regional markets, often through state-run or semi-private pharmaceutical entities.
3. Global Distributors
The global distribution of these formulations is limited but can be accessed through regional medical supply companies and specialized distributors. These channels primarily serve government agencies, hospitals, and emergency clinics.
Regulatory and Market Considerations
1. Regulatory Environment
Regonol is classified differently depending on jurisdiction. In the US, it is not approved by the FDA for commercial distribution, limiting direct imports. Conversely, in India and Russia, it enjoys government-approved manufacturing and distribution licenses. Suppliers operating internationally must navigate complex regulatory pathways, including import/export restrictions, licensing, and pharmacovigilance.
2. Supply Chain Risks
The niche nature of Regonol means supply may be constrained by regional manufacturing capacities, regulatory changes, and geopolitical factors. Suppliers often rely on regional production hubs, creating vulnerabilities in global supply continuity.
Emerging Sources and Future Supply Dynamics
1. Contract Manufacturing Organizations (CMOs)
In response to demand fluctuations, certain CMOs in India and China have expanded their capabilities to produce mephentermine sulfate API and formulations, often catering to regional markets or export obligations. These CMOs offer scalable solutions but require OEM partnerships or licensing agreements.
2. Potential for New Entrants
Current supply constraints suggest potential market entry for new players with compliant manufacturing processes. Regulatory clearance, quality assurance, and regional demand are critical factors influencing their success.
Conclusion: Key Insights
- Region-Specific Dominance: Indian and regional Asian manufacturers are the primary sources for both API and finished Regonol formulations, largely due to historical market presence and regional demand.
- Limited Global Availability: Due to regulatory restrictions and limited international approval, Regonol's supply outside Asia and Eastern Europe is scarce.
- Supply Chain Risks: Dependency on regional manufacturing and geopolitical factors create vulnerability, which may impact future supplies.
- Emerging Manufacturing Capacity: Contract manufacturers in Asia are increasingly capable of meeting regional demand, with potential for expansion once regulatory hurdles are addressed.
- Strategic Procurement: Healthcare organizations seeking Regonol should partner with verified regional distributors or establish direct supply agreements with reputable manufacturers, ensuring compliance with local regulations.
Key Takeaways
- The primary sources for Regonol are Indian and Chinese API manufacturers, complemented by regional finished formulation producers.
- Supply constraints stem from regulatory variability, regional manufacturing focus, and geopolitical factors.
- Companies should evaluate regional distributor credibility and ensure adherence to local pharmacopoeia standards.
- Emerging CMO capacity in Asia presents opportunities for diversification of supply sources.
- Critical to procurement strategies is a comprehensive understanding of the regulatory landscape in the target market.
FAQs
1. Is Regonol approved for use outside India and Russia?
Regonol is primarily approved in India and Russia. Its regulatory status in the US, EU, and other regions is limited, with many countries not officially recognizing or approving it for clinical use.
2. Who are the main API manufacturers of mephentermine sulfate?
Main API producers are regional manufacturers in India and China, such as Bharat Serums and some Chinese suppliers, although full transparency often remains proprietary.
3. Can I source Regonol directly from raw material manufacturers?
Accessing API directly is possible but often requires regulatory approvals, import licenses, and commercial agreements, making it suitable mainly for licensed pharmaceutical manufacturers.
4. Are there alternative drugs with similar clinical profiles?
Yes, other sympathomimetics like ephedrine or norepinephrine can substitute Regonol in some clinical settings, depending on regulatory approval and availability.
5. What are the risks associated with supplier reliance for Regonol?
Risks include regulatory non-compliance, manufacturing disruptions, geopolitical instability, and supply chain delays, emphasizing the need for diversified sourcing strategies.
References
- Indian Pharmacopoeia, 2020. Mephentermine Sulfate Monograph.
- World Health Organization (WHO). List of Essential Medicines.
- Indian Drug Manufacturers' Association (IDMA). Industry Reports, 2022.
- Chinese Pharmacopoeia, 2020. Pharmaceutical API Standards.
- Global trade databases indicating regional API and finished product exports.
Note: Due to the niche nature of Regonol and the proprietary confidentiality surrounding supply chains, specific manufacturer names and sources might be limited or confidential. Stakeholders should conduct direct due diligence before procurement.
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