Last updated: July 28, 2025
Introduction
SOTRADECOL, known generically as Carbenoxolone, is a historically significant pharmaceutical compound primarily used as a gastrointestinal agent. It is a derivative of glycyrrhizin from licorice root and has been traditionally used in managing gastric ulcers and related gastrointestinal disorders. Given the evolving landscape of pharmaceutical manufacturing and supply chains, identifying reliable suppliers for SOTRADECOL is crucial for pharmaceutical companies, distributors, and healthcare providers aiming to ensure drug availability, quality, and regulatory compliance.
Overview of SOTRADECOL (Carbenoxolone)
Chemical Profile and Therapeutic Use
Carbenoxolone acts as a soothing agent for gastrointestinal mucosa and exhibits anti-inflammatory and ulcer-healing properties. Its use has decreased over recent years, supplanted by newer therapies, but remains relevant in specific clinical settings and research applications.
Regulatory Status
SOTRADECOL possesses regulatory approvals across various jurisdictions, but its manufacturing and distribution are often governed by stringent quality standards, especially in markets like the United States, Europe, and Asia.
Major Suppliers and Manufacturers
Identifying suppliers of SOTRADECOL involves analyzing global pharmaceutical manufacturers, active pharmaceutical ingredient (API) producers, and authorized distributors. The supply landscape has evolved due to patent expirations, manufacturing consolidations, and evolving regulatory standards.
1. International API Producers
a. Tertiary Manufacturers in China and India
China and India serve as primary hubs for API production, including compounds like Carbenoxolone. Several manufacturers operate under Good Manufacturing Practices (GMP) standards, providing APIs either directly to pharmaceutical companies or through licensed distributors.
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Zhuhai Le Remedy Biotech Co., Ltd. (China): Known for producing glycyrrhizin derivatives, including Carbenoxolone, with export capabilities to global markets[1].
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Hetero Labs Ltd. (India): An established generic API manufacturer, manufacturing various gastrointestinal agents and derivatives, potentially including Carbenoxolone[2].
b. European and US API Suppliers
Though less common due to regulatory barriers, some European and US firms produce or source Carbenoxolone for specialized applications:
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Pharmaceutica Ltd. (UK): Known for sourcing and distributing specialty APIs, including licorice derivatives.
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Gattefossé (France): While primarily a cosmetic and pharmaceutical excipient supplier, they maintain a portfolio of botanical extracts and derivatives, including glycyrrhizin derivatives.
(Note: Specific proprietary APIs like SOTRADECOL are often supplied via licensed distributors or directly via manufacturing agreements; precise supplier data can be protected by confidentiality agreements.)
2. Licensed Distributors and Commercial Suppliers
Many pharmaceutical companies prefer procuring from authorized distributors to ensure compliance and quality assurance:
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Aurobindo Pharma Ltd. – Offers various gastrointestinal API products, including derivatives of glycyrrhizin, depending on regional approvals.
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Zhejiang Huahai Pharmaceutical Co., Ltd. (China): Major API supplier with export licenses, potentially including SOTRADECOL.
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Sigma-Aldrich / MilliporeSigma (part of Merck): Provides a range of botanical extracts and derivatives, and may supply Carbenoxolone for research purposes.
Regulatory and Quality Considerations
Suppliers must adhere to good manufacturing practices (GMP), be compliant with the FDA, EMA, or other regional authorities, and ensure batch-to-batch consistency. The criticality of quality assurance extends to potency, purity, and the absence of contaminants, especially given the compound's derivation from botanical sources.
Supply Chain Challenges
The supply of pharmaceutical APIs like SOTRADECOL faces hurdles such as:
- Regulatory Barriers: Stringent approval processes hinder a wide supplier network.
- Manufacturing Capacity: Limited production capacity for specialized compounds can cause shortages.
- Quality Variability: Variability in botanical-derived products necessitates rigorous quality control.
- Supply Chain Disruptions: Global events, such as pandemics or geopolitical tensions, impact API manufacturing and distribution.
Strategic Sourcing Recommendations
- Verification of GMP Compliance: Confirm supplier adherence to international quality standards.
- Due Diligence on Regulatory Approvals: Ensure suppliers’ APIs meet the regulatory requirements of the target market.
- Diversify Supplier Base: Avoid reliance on single sources by establishing multiple supplier relationships.
- Engage with Established Distributors: Collaborate with authorized distributors familiar with the product to mitigate risks.
- Monitor Market Dynamics: Stay informed on manufacturing licensing, patent statuses, and geopolitical influences affecting supply.
Conclusion
While specific proprietary suppliers of SOTRADECOL (Carbenoxolone) are not publicly enumerated due to confidentiality and competitive reasons, the key pathways involve sourcing from certified international API producers, predominantly in China and India, and through reputable distributors compliant with global regulatory standards. Pharmaceutical entities must prioritize quality, compliance, and supply chain resilience to ensure steady access to SOTRADECOL, especially where therapeutic or research needs persist.
Key Takeaways
- The primary source of SOTRADECOL is through API manufacturers in China and India, subject to quality standards.
- Reliable suppliers must demonstrate compliance with GMP and regional regulatory requirements.
- Establishing relationships with authorized distributors mitigates risks associated with quality and supply interruptions.
- The complex regulatory environment necessitates vigilant oversight of sourcing strategies.
- Diversification and ongoing market intelligence are essential to maintain a resilient supply chain for niche pharmaceuticals like SOTRADECOL.
Frequently Asked Questions (FAQs)
1. Is SOTRADECOL still widely available in the global market?
Availability varies; while it remains accessible through certain suppliers, newer therapies have reduced its clinical prominence, impacting supply and production focus.
2. What are the main regions producing SOTRADECOL APIs?
China and India are the predominant regions, with some European and US-based firms involved primarily in research-grade supplies.
3. How can buyers verify supplier quality and compliance?
Review GMP certifications, conduct audits, and request batch validation reports. Working with reputable distributors also helps ensure quality.
4. Are there any patent restrictions on sourcing Carbenoxolone?
Patents for SOTRADECOL have long expired, enabling generic manufacturing, but regional regulations may impose restrictions on procurement and use.
5. What are the main risks associated with sourcing SOTRADECOL?
Risks include quality variability, regulatory non-compliance, supply disruptions, and geopolitical factors influencing manufacturing and trade.
References
[1] Zhuhai Le Remedy Biotech Co., Ltd. official website, product catalogs.
[2] Hetero Labs Ltd., corporate disclosures and API portfolio.
(Additional references would depend on publicly available and validated industry reports and manufacturer disclosures.)
