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Suppliers and packagers for generic pharmaceutical drug: CROTAMITON
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CROTAMITON
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: Crotamiton
Introduction
Crotamiton is a topical medication primarily utilized for its antipruritic and scabicidal properties. It is conventionally prescribed for conditions like scabies and eczema to alleviate itching and eliminate mites. As demand for antiparasitic agents persists globally, identifying reliable suppliers for Crotamiton remains crucial for pharmaceutical companies, distributors, and healthcare providers. This report provides a comprehensive overview of the primary suppliers, manufacturing sources, and market dynamics surrounding Crotamiton.
Regulatory Status and Market Overview
Crotamiton is approved in multiple jurisdictions, including the United States, European Union, and various Asian markets. While not as widely manufactured as other antiparasitic agents like permethrin or ivermectin, it maintains niche significance in dermatological therapeutics. The global market for antipruritic medications is expected to expand, driven by increasing prevalence of skin conditions and demand for topical agents. Consequently, suppliers' capabilities and distribution channels directly influence drug availability.
Major Suppliers and Manufacturers
1. Chinese Pharmaceutical Manufacturers
China remains a dominant player in the production of Crotamiton, owing to the country's extensive pharmaceutical manufacturing infrastructure. Several Chinese pharmaceutical companies are recognized for manufacturing Crotamiton APIs and finished formulations.
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Guangzhou Pharmaceutical Industry Research Institute:
This state-owned enterprise supplies Crotamiton API primarily for domestic consumption and export markets. They adhere to GMP standards and export to several Asian and African countries. -
Zhejiang Medicines & Health Products Import & Export Co., Ltd.:
Offers Crotamiton API and formulations, with a focus on Asian markets. Their manufacturing complies with international quality standards, and they provide both bulk API and finished topical products. -
Shandong Xinhua Pharmaceutical Co., Ltd.:
A notable producer of dermatological active ingredients, including Crotamiton API, serving global markets through authorized distribution partners.
2. Indian Manufacturers
India consolidates its position as an active pharmaceutical ingredient (API) producer for various dermatological drugs, including Crotamiton.
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Macleods Pharmaceuticals:
Known for extensive dermatological product offerings, Macleods manufactures Crotamiton-based creams and lotions for domestic markets and exports. -
Aarti Drugs Ltd.:
Produces Crotamiton API complying with global quality standards, supporting formulations used in multiple countries, especially in Asia, Africa, and Latin America. -
Bharat Serum & Vaccines:
While primarily focused on vaccines, it also manufactures dermatological APIs, including Crotamiton, for licensed partners.
3. European and US Suppliers
High-quality Crotamiton APIs and formulations from Europe and the US are less prevalent but available from select specialized firms.
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Siegfried AG (Switzerland):
A leading global manufacturer of APIs, including dermatological agents, with capabilities to produce Crotamiton under strict GMP compliance. -
BASF (Germany):
Known for chemical intermediates and APIs, BASF occasionally supplies dermatological compounds, with a focus on high-grade formulations for pharmaceutical companies. -
LGM Pharma (USA):
Specializes in sourcing and distributing APIs globally. Offers Crotamiton APIs to pharmaceutical companies seeking reliable, quality-assured sources.
Contract Manufacturing and Private Label Opportunities
Most global suppliers offer API manufacturing services and private label products. Contract manufacturing organizations (CMOs) often produce Crotamiton topical formulations for international pharmaceutical companies, enabling rapid market access without extensive in-house formulation capabilities.
Key Characteristics of Suppliers
- Regulatory Compliance: GMP certification and adherence to AQC (API Quality Certification) standards.
- Certifications and Quality Assurance: ISO certifications, cGMP compliance, and documentation to meet international standards.
- Export Capabilities: Many suppliers focus on export markets, especially in developing regions where dermatological needs are unmet.
- Pricing Dynamics: Chinese and Indian suppliers typically offer competitive pricing, which can influence procurement decisions.
Supply Chain Challenges and Considerations
- Regulatory Variance: Differences in regulatory approvals across regions may delay market entry or limit supplier options.
- Quality Variability: Variations in manufacturing standards necessitate rigorous qualification processes.
- Intellectual Property and Patent Status: Although Crotamiton is off-patent in many regions, legal considerations around formulations and distribution agreements influence supplier relationships.
- Supply Security: Dependence on geographically concentrated suppliers (e.g., China and India) poses risks, emphasizing the importance of diversified supply chains.
Emerging Opportunities
- Supply Chain Diversification: Companies are exploring suppliers in Southeast Asia and Eastern Europe for reduced geopolitical and logistical risks.
- Regulatory Harmonization: Efforts to streamline approvals may facilitate broader supplier access and faster market penetration.
- Biotech and Formulation Advancements: Development of new formulations, including combination therapies, may expand supplier portfolios and demand.
Conclusion
The procurement of Crotamiton relies heavily on manufacturers primarily based in China and India, supported by select suppliers in Europe and North America. Maintaining supplier quality, regulatory compliance, and supply continuity remains paramount. Strategic partnerships with reputable manufacturers and CMOs can ensure reliable supply chains, cost efficiencies, and timely access to this dermatological agent.
Key Takeaways
- Chinese and Indian manufacturers dominate the Crotamiton API market, offering cost-effective options with broad export capabilities.
- European and US-based suppliers provide higher assurance standards, suitable for markets requiring stringent regulatory compliance.
- Diversification of supplier base mitigates geopolitical risk and supply disruptions.
- Regulatory navigation is essential for market entry; suppliers with established compliance facilitate smoother approvals.
- Contract manufacturing offers scalable options for pharmaceutical companies seeking private label formulations.
FAQs
Q1: Is Crotamiton available from multiple suppliers globally?
A: Yes, primarily from Chinese and Indian manufacturers, with select high-quality options from Europe and the US.
Q2: What are the regulatory challenges associated with sourcing Crotamiton?
A: Variations in regional approvals, quality standards, and registration processes can complicate procurement and distribution.
Q3: How can companies ensure the quality of Crotamiton supplies?
A: By sourcing from GMP-certified manufacturers, verifying certifications, and conducting rigorous quality assessments.
Q4: Are there private label opportunities for Crotamiton formulations?
A: Yes, contract manufacturing organizations frequently offer private label production to meet market-specific needs.
Q5: What are future industry trends impacting Crotamiton suppliers?
A: Increased regulatory harmonization, supply chain diversification, and development of advanced topical formulations.
Sources:
[1] GlobalData Pharmaceutical Market Reports, 2022.
[2] Chinese Ministry of Industry and Information Technology, 2022.
[3] Indian Pharmaceutical Industry Association, 2022.
[4] European Medicines Agency, 2023.
[5] U.S. Food & Drug Administration (FDA), 2023.
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