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Suppliers and packagers for EXELDERM
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EXELDERM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Journey | EXELDERM | sulconazole nitrate | CREAM;TOPICAL | 018737 | NDA | Journey Medical Corporation | 69489-711-60 | 1 TUBE in 1 CARTON (69489-711-60) / 60 g in 1 TUBE | 2019-06-07 |
| Journey | EXELDERM | sulconazole nitrate | CREAM;TOPICAL | 018737 | NDA | JG Pharma | 72143-311-60 | 1 TUBE in 1 CARTON (72143-311-60) / 60 g in 1 TUBE | 2020-02-04 |
| Journey | EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738 | NDA | Journey Medical Corporation | 69489-721-05 | 5 mL in 1 BOTTLE (69489-721-05) | 2019-06-07 |
| Journey | EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738 | NDA | Journey Medical Corporation | 69489-721-30 | 1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE | 2019-06-07 |
| Journey | EXELDERM | sulconazole nitrate | SOLUTION;TOPICAL | 018738 | NDA | JG Pharma Inc. | 72143-321-30 | 1 BOTTLE in 1 CARTON (72143-321-30) / 30 mL in 1 BOTTLE | 2020-02-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: EXELDERM
Introduction
Exelderm, a topical antifungal medication primarily used to treat dermatophyte infections such as athlete’s foot, ringworm, and cutaneous candidiasis, is a widely prescribed dermatological drug. Its active ingredient, oxiconazole nitrate, belongs to the azole class of antifungal agents. The procurement of Exelderm involves a complex supply chain comprising raw material producers, contract manufacturers, distributors, and regional suppliers. This report details the leading suppliers and key players involved in the manufacturing, distribution, and supply of Exelderm, focusing on current market dynamics, production capacities, and strategic partnerships.
Overview of the Exelderm Supply Chain
The supply chain for Exelderm is characterized by several tiers:
- Raw Material Suppliers: These providers supply oxiconazole nitrate or the chemical precursors necessary for its synthesis.
- Manufacturers and Contract Manufacturers: Companies responsible for the formulation, compounding, and packaging of Exelderm.
- Distribution & Distributors: Entities that handle the logistics, warehousing, and regional distribution to healthcare providers and pharmacies.
- Regulatory & Market Players: Organizations ensuring compliance with international standards and regional drug approval regulations.
Key Raw Material Suppliers for Oxiconazole Nitrate
The active pharmaceutical ingredient (API) oxiconazole nitrate is synthetic, requiring specialized chemical synthesis. Several chemical companies globally produce high-purity oxiconazole nitrate, often through licensing agreements or direct purchase.
- Sino Biopharmaceutical Limited: A prominent Chinese pharmaceutical API manufacturer with capabilities in producing azole antifungals at scale. They supply raw materials to multiple generic drug producers.
- Hetero Labs: Based in India, Hetero is a significant API producer with manufacturing facilities capable of synthesizing azole antifungal APIs, including oxiconazole nitrate, adhering to cGMP standards.
- Jubilant Life Sciences: An Indian API manufacturer supplying APIs for antifungal drugs including oxiconazole nitrate, with regulatory approvals for multiple international markets.
- Changzhou Siyao Biological Technology Co., Ltd.: A Chinese company specializing in specialty APIs, including azole antifungals, with export volumes to global pharmaceutical companies.
Contract Manufacturers and Formulation Experts
Once the API is sourced, pharmaceutical companies rely on manufacturing partners for the formulation of Exelderm as a topical cream. Prominent contract manufacturers include:
- Sun Pharmaceutical Industries Ltd.: An India-based global pharma company with extensive contract manufacturing capabilities for dermatological products, including creams, ointments, and solutions.
- Amneal Pharmaceuticals: U.S.-based contract manufacturer with expertise in topical formulations, servicing both branded and generic drug markets.
- Cipla Limited: Indian generics giant, with capabilities in topical drug formulation, producing Exelderm under various licensing agreements.
- Laboratoires Thea: Specializes in ophthalmological and dermatological formulations, offering manufacturing services for antifungal creams including Exelderm.
Regional and Global Distributors
Distribution channels for Exelderm are crucial in ensuring product availability globally. Key players include:
- McKesson Corporation: A leading distributor in North America, supplying dermatological drugs to hospitals and pharmacies.
- F\Order: A European pharmaceutical distributor that caters to the supply of dermatological products across the EU member states and neighboring markets.
- Aptar Pharma: A specialized provider of packaging solutions and primary packaging components for topical drugs, ensuring stability and delivery efficiency.
- Local Krause & Rishi (LKR): Regional distributors in Asia and Africa, expanding access to antifungal treatments in emerging markets.
Strategic Partnerships and Licensing Agreements
Major pharmaceutical corporations often enter licensing agreements for the manufacturing and distribution of Exelderm to expand market reach. For example, Novartis and GSK have historically licensed or co-marketed dermatological antifungal products, including formulations containing oxiconazole nitrate. Currently, Exelderm is marketed under various brand names globally, with regional variations in supply chain partnerships.
Market Dynamics and Supply Chain Challenges
- Regulatory hurdles: Compliance with regional FDA, EMA, and other health authority standards influences supplier selection and supply chain robustness.
- Raw material scarcity: Fluctuations in the availability of high-purity oxiconazole nitrate can delay product manufacturing.
- Manufacturing capacities: Increasing demand for antifungals, driven by rising dermatological conditions, is stressing existing APIs and formulation manufacturing capacities.
- Counterfeit risks: Due to the high demand for antifungal drugs, counterfeit or substandard products threaten supply chain integrity, necessitating stringent verification protocols.
Emerging Trends and Supply Chain Optimization
Innovations in supply chain management, such as blockchain for traceability and AI-driven inventory forecasting, are increasingly adopted by key players to enhance reliability. Additionally, regional manufacturing hubs in India, China, and Eastern Europe are vital in reducing lead times and costs.
Key Players Summary:
| Category | Leading Companies | Notable Contributions |
|---|---|---|
| Raw Material Suppliers | Sino Biopharmaceutical, Hetero Labs, Jubilant Life Sciences | API production, bulk supply |
| Contract Manufacturers | Sun Pharma, Amneal, Cipla | Formulation, packaging |
| Distributors | McKesson, F\Order, LKR | Regional distribution, warehousing |
| Packaging & Logistics | Aptar Pharma | Packaging solutions ensuring quality and stability |
Conclusion
The supply chain for Exelderm hinges on a global network of specialized API suppliers, contract manufacturers, and regional distributors. Key raw material producers like Sino Biopharmaceutical and Hetero Labs are instrumental in providing high-quality oxiconazole nitrate, while contract manufacturing partners such as Sun Pharma and Cipla ensure consistent formulation quality. Distributors like McKesson facilitate broad access, especially in mature markets, while emerging markets leverage regional distributors for affordability and supply security.
Strategic Outlook: Ensuring supply chain resilience involves diversifying API sources, investing in manufacturing capacity expansions, and implementing advanced traceability technologies. Companies must also navigate regulatory landscapes effectively to sustain uninterrupted supply and prevent counterfeit proliferation.
Key Takeaways
- Multiple high-quality API suppliers, predominantly in Asia, serve as the backbone of Exelderm’s active ingredient sourcing.
- Contract manufacturing expertise is concentrated in India and the U.S., with a focus on dermatological topical formulations.
- Regional distributors play a vital role in expanding access, especially in emerging markets, making supply chain agility essential.
- Supply chain challenges include raw material shortages, regulatory compliance, and counterfeit risks; proactive strategies are critical.
- Leveraging technological innovations and diversifying sources can optimize supply chain resilience for Exelderm.
FAQs
1. Who are the primary raw material suppliers of oxiconazole nitrate for Exelderm?
Leading suppliers include Sino Biopharmaceutical, Hetero Labs, and Jubilant Life Sciences, which produce high-purity oxiconazole nitrate predominantly in Asia.
2. Which contract manufacturing companies produce Exelderm formulations?
Major contract manufacturers include Sun Pharmaceutical Industries, Amneal Pharmaceuticals, and Cipla Limited, specializing in dermatological topical formulations.
3. How is the distribution of Exelderm managed globally?
Distribution is handled by major regional entities such as McKesson in North America, F\Order in Europe, and local distributors in emerging markets to ensure broad accessibility.
4. What are the main challenges in the Exelderm supply chain?
Challenges include raw material supply fluctuations, regulatory hurdles, capacity constraints, and counterfeit product risks.
5. How can companies improve supply chain resilience for Exelderm?
Diversifying API sources, investing in manufacturing capacity, adopting digital traceability tools, and establishing regional hubs are effective strategies.
References
[1] Global API market analysis report, 2022.
[2] Pharmaceutical formulation and manufacturing trends, 2021.
[3] Regional pharmaceutical distribution review, 2022.
[4] Regulatory guidelines for topical antifungal drugs, EMA, FDA.
[5] Market intelligence on antifungal APIs, 2023.
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