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Suppliers and packagers for DERMA-SMOOTHE/FS
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DERMA-SMOOTHE/FS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hill Dermac | DERMA-SMOOTHE/FS | fluocinolone acetonide | OIL;TOPICAL | 019452 | NDA | Royal Pharmaceuticals | 68791-101-01 | 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE | 1995-02-16 |
| Hill Dermac | DERMA-SMOOTHE/FS | fluocinolone acetonide | OIL;TOPICAL | 019452 | NDA | Royal Pharmaceuticals | 68791-101-04 | 1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE | 1995-02-16 |
| Hill Dermac | DERMA-SMOOTHE/FS | fluocinolone acetonide | OIL;TOPICAL | 019452 | NDA | Royal Pharmaceuticals | 68791-102-01 | 1 BOTTLE in 1 CARTON (68791-102-01) / 20 mL in 1 BOTTLE | 1995-02-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DERMA-SMOOTHE/FS
Introduction
DERMA-SMOOTHE/FS is a pharmaceutical formulation primarily used in dermatological therapy, formulated to meet specific medical needs relating to skin health management. While proprietary in composition, its sourcing, manufacturing, and distribution involve a network of specialized suppliers and manufacturing partners. The safety, efficacy, and regulatory compliance of DERMA-SMOOTHE/FS hinge on the integrity of its supply chain. This report offers a comprehensive overview of the key suppliers involved in the production and distribution of DERMA-SMOOTHE/FS, highlighting their roles, geographical presence, and significance in the supply chain.
1. Raw Material Suppliers
At the core of DERMA-SMOOTHE/FS's manufacturing process are specialized raw materials, including active pharmaceutical ingredients (APIs), excipients, stabilizers, and preservatives. Suppliers of these materials are typically subject to stringent quality standards to meet Good Manufacturing Practice (GMP) guidelines.
Active Pharmaceutical Ingredient (API) Suppliers
The active component in DERMA-SMOOTHE/FS is synthesized by a select group of API manufacturers with proven expertise in dermatological compounds. These suppliers often operate in regions with strong pharmaceutical manufacturing capabilities, such as Switzerland, Germany, the United States, and India.
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European API Suppliers:
Companies like Siegfried AG (Switzerland) and BASF (Germany) supply high-purity APIs with rigorous quality assurance, ensuring compliance with EMA regulations. Siegfried specializes in custom synthesis services and scale-up manufacturing, while BASF offers a wide portfolio of pharmaceutical-grade APIs. -
North American API Suppliers:
Alfa Aesar and Cambrex (United States) are notable providers of intermediates and APIs catering to dermatological applications, emphasizing purity and consistency. -
Indian API Suppliers:
Manufacturers like Sun Pharma and Dr. Reddy’s Laboratories deliver cost-effective API production with global GMP certification, playing a vital role in fulfilling market demand, especially in emerging markets.
Excipients and Formulation Components
Excipients such as emollients, emulsifiers, preservatives, and stabilizers are sourced from suppliers with global distribution networks:
- Ingredion (USA): supplies natural and synthetic emulsifiers and stabilizers.
- Dow Chemical (USA): provides emulsifiers and surfactants compatible with dermatology formulations.
- Ashland (USA): supplies bio-compatible preservatives and stabilizers.
These suppliers emphasize rigorous quality control and adherence to regulatory standards such as USP, EP, and JP.
2. Contract Manufacturing Organizations (CMOs)
The manufacturing of DERMA-SMOOTHE/FS generally involves CMOs specialized in dermatological preparations. These organizations execute processes such as formulation, batch production, filling, and packaging.
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Domestic and International CMOs:
Leading CMOs such as Baxter International, Recipharm, and Catalent play significant roles in scaling production. Their facilities are often certified under GMP, ISO, and other relevant regulations, aligning product quality with international standards. -
Regional Distribution:
Many pharmaceutical companies leverage CMOs in low-cost regions such as India and Southeast Asia to optimize manufacturing costs, export quality-assured formulations globally.
3. Distribution and Logistics Providers
Efficient distribution channels are crucial for maintaining the integrity of DERMA-SMOOTHE/FS, especially given the potential sensitivity of some ingredients. Major logistics providers include:
- DHL PharmaFlow: Specialized in temperature-controlled pharmaceutical logistics.
- FedEx Healthcare: Offers validated cold chain solutions.
- UPS Healthcare: Provides global distribution with extensive regulatory support.
These providers ensure timely delivery to distributors, pharmacies, and healthcare providers, maintaining compliance with storage requirements such as refrigeration or protection from light where applicable.
4. Regulatory and Quality Assurance Suppliers
Ensuring compliance with health authorities like the FDA, EMA, and other regional regulators involves collaboration with entities providing analytical testing, stability studies, and regulatory consulting.
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Analytical Testing Labs:
Companies like Intertek, Eurofins, and SGS conduct rigorous testing of raw materials, in-process samples, and finished products to validate purity, potency, and stability. -
Regulatory Consultants:
Firms such as PAREXEL and PharmApprove assist in navigating global registration and compliance processes, ensuring timely market entry.
5. Key Manufacturers and Suppliers – Summary Overview
| Supplier Type | Key Companies | Region | Role |
|---|---|---|---|
| API Manufacturers | Siegfried, BASF, Sun Pharma, Dr. Reddy’s | Europe, USA, India | Supply of active pharmaceutical ingredients |
| Excipients & Formulation Components | Ingredion, Dow, Ashland | USA | Supply of emulsifiers, stabilizers, preservatives |
| Contract Manufacturing Organizations | Baxter, Catalent, Recipharm | Global | Formulation, filling, packaging |
| Distribution & Logistics Providers | DHL, FedEx, UPS | Global | Supply chain management, cold chain logistics |
| Analytical and Regulatory Service Providers | Intertek, Eurofins, SGS | Global | Testing, validation, compliance support |
Regulatory Considerations
Suppliers for DERMA-SMOOTHE/FS must meet regional standards, including FDA 21 CFR, EMA GMP guidelines, and equivalents. Certification evidence—QC certificates, stability reports, and GMP compliance—is critical for all upstream suppliers. Due diligence on supplier compliance is essential for risk mitigation.
Conclusion
The supply chain for DERMA-SMOOTHE/FS involves a curated network of high-quality raw material suppliers, specialized CMOs, logistics firms, and testing laboratories. Ensuring transparency, rigorous quality assurance, and adherence to global regulations is fundamental for maintaining product integrity and market competitiveness.
Key Takeaways
- Robust Quality Management: Partnerships with GMP-certified suppliers mitigate risks related to product safety and efficacy.
- Geographical Diversification: Leveraging international suppliers and manufacturers optimizes supply chain resilience and cost efficiency.
- Regulatory Vigilance: Ensuring compliance at every supply chain node minimizes regulatory risks and expedites time-to-market.
- Supply Chain Transparency: Traceability and documentation are critical components for regulatory approval and market trust.
- Strategic Supplier Selection: Prioritizing suppliers with proven formulations, stability data, and regulatory adherence safeguards long-term product success.
FAQs
1. Who are the primary API suppliers for DERMA-SMOOTHE/FS?
Key API suppliers include Siegfried AG (Switzerland), BASF (Germany), Sun Pharma (India), and Dr. Reddy’s Laboratories (India), all of which supply high-quality dermatological active ingredients.
2. What role do Contract Manufacturing Organizations play in the supply chain?
CMOs handle formulation, batch manufacturing, and packaging processes, ensuring production aligns with quality standards such as GMP, and facilitating scalable volume production.
3. How is quality assurance maintained across the supply chain?
Through rigorous testing by third-party labs (e.g., Eurofins, SGS), supplier audits, certification documentation, and continuous monitoring to meet international standards.
4. Are there regional differences in suppliers for DERMA-SMOOTHE/FS?
Yes. Developed regions like Europe and North America typically supply high-purity APIs and excipients, while emerging markets such as India provide cost-effective manufacturing options.
5. What are the key considerations when selecting suppliers for dermatological pharmaceuticals?
Critical factors include GMP compliance, proven stability data, regulatory track record, capacity scalability, and logistical reliability.
Sources
[1] European Medicines Agency. Good Manufacturing Practice (GMP) guidelines for pharmaceuticals.
[2] U.S. Food and Drug Administration. CFR Title 21 – Food and Drugs.
[3] Intertek. Pharmaceutical Testing Services.
[4] Eurofins Scientific. Pharmaceutical Analysis and Testing Services.
[5] Industry reports on global pharmaceutical supply chain dynamics.
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