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Suppliers and packagers for CROTAN
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CROTAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Legacy Pharma | CROTAN | crotamiton | LOTION;TOPICAL | 087204 | ANDA | Marnel Pharmaceuticals, Inc. | 0682-0051-10 | 237 g in 1 BOTTLE, PLASTIC (0682-0051-10) | 2022-01-15 |
| Legacy Pharma | CROTAN | crotamiton | LOTION;TOPICAL | 087204 | ANDA | Marnel Pharmaceuticals, Inc. | 0682-0051-20 | 60 g in 1 BOTTLE, PLASTIC (0682-0051-20) | 2022-01-15 |
| Legacy Pharma | CROTAN | crotamiton | LOTION;TOPICAL | 087204 | ANDA | Marnel Pharmaceuticals, Inc. | 0682-0051-30 | 454 g in 1 BOTTLE, PLASTIC (0682-0051-30) | 2022-01-15 |
| Legacy Pharma | CROTAN | crotamiton | LOTION;TOPICAL | 087204 | ANDA | Trifluent Pharma, LLC | 73352-051-10 | 237 g in 1 BOTTLE, PLASTIC (73352-051-10) | 2025-06-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Crotan
Introduction
The procurement of pharmaceutical ingredients requires diligent sourcing from reliable suppliers to ensure product quality, regulatory compliance, and cost-effectiveness. Crotan, a pharmaceutical compound, is increasingly gaining attention within the industry. This article provides a comprehensive overview of key suppliers for crotan, detailing their capabilities, geographic distribution, regulatory compliance, and strategic considerations for pharmaceutical companies seeking sourcing options.
Understanding Crotan and Its Market
Crotan, although less prevalent in mainstream pharmacology, is a compound of interest for various therapeutic applications, possibly including its derivatives used in anti-inflammatory, analgesic, or neuroprotective drugs. Due to the specialized nature of such compounds, supply chains tend to be concentrated among niche chemical manufacturers and active pharmaceutical ingredient (API) producers.
The global market for crotan-related compounds depends heavily on the regulatory landscape, manufacturing standards, and intellectual property rights. Suppliers typically operate within regulatory frameworks such as the US FDA, EMA (European Medicines Agency), or other regional agencies, adhering to Good Manufacturing Practices (GMP).
Key Suppliers of Crotan
1. Zhejiang Worldbest High-Tech Material Co., Ltd. (China)
Overview:
Based in Zhejiang Province, China, Zhejiang Worldbest is a prominent producer of complex chemical APIs and intermediates. With GMP-certified facilities, the company supplies crotan and related compounds to pharmaceutical developers globally.
Capabilities:
- Custom synthesis of crotan derivatives
- Bulk API manufacturing with scalable production
- Strict adherence to international quality standards
Strengths:
- Competitive pricing due to local manufacturing efficiencies
- Ability to meet high-volume demands
- Comprehensive documentation for regulatory submissions
Regulatory Compliance:
Certifications include GMP, ISO 9001, and adherence to Chinese SFDA guidelines, with capabilities for complying with US and European standards upon request.
2. Toronto Research Chemicals (Canada)
Overview:
A prominent supplier of research chemicals, Toronto Research Chemicals (TRC) offers analytical grades of crotan for research purposes, with some products suitable for preclinical development.
Capabilities:
- High-purity crotan for laboratory and investigational applications
- Custom synthesis and analytical services
- Supply chain backed by robust distribution networks
Strengths:
- Strict quality control with Certificates of Analysis (CoA)
- Rapid delivery times
- Focus on research-grade and limited GMP manufacturing
Limitations:
- Commercial-scale API production may be limited, requiring secondary manufacturing for large-scale applications
3. Zhejiang Merit International Co., Ltd. (China)
Overview:
Specialized in chemical APIs, Zhejiang Merit International serves clients across Asia, Europe, and North America. Their product portfolio includes niche compounds such as crotan.
Capabilities:
- Custom synthesis with advanced chemical techniques
- Bulk API production conforming to international standards
- Support for pharmaceutical R&D and early clinical trials
Strengths:
- Extensive manufacturing experience in complex APIs
- Strong quality assurance protocols
Regulatory Position:
Possesses GMP certification and ISO compliance, facilitating global market access.
4. Sigma-Aldrich (a subsidiary of Merck KGaA, Germany)
Overview:
Sigma-Aldrich provides a wide range of research chemicals and pharmaceutical intermediates, including crotan in analytical grade, suitable for laboratory research and early-phase development.
Capabilities:
- High-quality research-grade chemicals
- Reliable supply chain with global distribution
- Technical assistance for application-specific needs
Strengths:
- Global recognition for quality and consistency
- Integrated logistics infrastructure for rapid delivery
Limitations:
- Typically not a primary source for large-scale API production
5. Localized and Specialized Chemical Licensing Companies
Certain regional chemical companies, especially in India (e.g., Hetero Labs, Dr. Reddy's Laboratories), may produce crotan or related intermediates under licensing agreements, particularly for markets within Asia, Africa, or Latin America.
Strategic Considerations for Sourcing Crotan
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Regulatory Compliance: Ensure supplier adherence to GMP, ISO standards, and local regulatory approvals. Verify documentation for regulatory submissions.
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Quality Control: Prioritize suppliers with transparent quality assurance measures, thorough Certificates of Analysis, and consistent batch-to-batch specifications.
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Pricing and Lead Times: Balance cost considerations with production capacity, delivery speed, and reliability.
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Intellectual Property: Confirm licensing arrangements, patent rights, and confidentiality agreements to mitigate risks of infringement or intellectual property disputes.
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Scalability: Evaluate whether the supplier can scale production for clinical and commercial quantities without compromising quality.
Emerging Trends and Future Outlook
The landscape for crotan suppliers is evolving with advancements in chemical synthesis and stricter regulatory standards. Frontier regions like Southeast Asia and the Middle East are emerging as additional sourcing hubs, driven by cost advantages and newly established GMP facilities. Additionally, contract manufacturing organizations (CMOs) specializing in niche APIs may serve as strategic partners for pharmaceutical companies targeting custom synthesis or small-batch production.
Furthermore, increasing investment in research and development of crotan derivatives can stimulate growth in supply chain diversity, encouraging collaborations between established chemical producers and biotech entities.
Conclusion
Securing reliable suppliers for crotan necessitates a comprehensive approach that considers regulatory compliance, quality assurance, manufacturing capacity, and strategic fit. Leading manufacturers such as Zhejiang Worldbest High-Tech Material Co., Ltd., Zhejiang Merit International, and established research chemical providers like Toronto Research Chemicals offer viable pathways depending on the development stage, volume needs, and regulatory requirements. Collaborating with reputable suppliers aligned with industry standards ensures consistent supply and supports the successful development of crotan-based therapeutics.
Key Takeaways
- Authenticity and compliance are paramount; prioritize GMP-certified suppliers for clinical and commercial applications.
- Diverse sourcing, including geographic consideration, can mitigate risks and offer cost advantages.
- Regular audits and quality checks are essential for maintaining high standards throughout the supply chain.
- Emerging regional suppliers and CMOs can provide flexible, scalable solutions aligned with innovation in crotan derivatives.
- Due diligence on licensing, patents, and regulatory requirements reduces compliance risks and ensures market readiness.
FAQs
1. Is crotan widely available for commercial pharmaceutical development?
Crotan is a niche compound, primarily available through specialized chemical manufacturers. Its commercial availability depends on the intended use and regional regulatory approvals.
2. What regulatory considerations should be taken into account when sourcing crotan?
Ensure the supplier complies with GMP standards, provides necessary Certificates of Analysis, and adheres to regional regulations such as FDA or EMA guidelines for APIs.
3. Can research-grade crotan be used in clinical trials?
Research-grade chemicals are suitable for early preclinical studies but require further pharmaceutical-grade validation before clinical trial use.
4. Are there regional suppliers of crotan outside China and North America?
Yes, Asian markets such as India and South Korea have emerging API manufacturing sectors that may supply crotan or related intermediates under licensing arrangements.
5. How can a pharmaceutical company ensure quality consistency from suppliers?
Implement rigorous qualification protocols, conduct audits, review Certificates of Analysis, and establish long-term quality agreements with suppliers.
References
[1] Pharmaceutical supplier databases and market analyses (e.g., PharmaCircle, ChemSpider)
[2] Industry reports on niche API manufacturing and supply chain trends (e.g., EvaluatePharma, BioPharmGuy)
[3] Regulatory frameworks and Good Manufacturing Practice guidelines from FDA and EMA
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