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Suppliers and packagers for generic pharmaceutical drug: SELENIUM SULFIDE
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SELENIUM SULFIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Padagis Us | SELENIUM SULFIDE | selenium sulfide | LOTION/SHAMPOO;TOPICAL | 089996 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-040-64 | 118 mL in 1 BOTTLE (45802-040-64) | 2006-09-25 |
| Padagis Us | SELENIUM SULFIDE | selenium sulfide | LOTION/SHAMPOO;TOPICAL | 089996 | ANDA | A-S Medication Solutions | 50090-0242-0 | 118 mL in 1 BOTTLE (50090-0242-0) | 2006-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Selenium Sulfide
Introduction
Selenium sulfide is a pharmaceutical active ingredient predominantly used in medicated shampoos to treat seborrheic dermatitis, dandruff, and tinea versicolor. Its antifungal and keratolytic properties make it a critical component in dermatological formulations. Ensuring a consistent supply of high-quality selenium sulfide is vital for pharmaceutical companies, contract manufacturing organizations (CMOs), and retailers. This article provides an in-depth overview of the leading suppliers globally, examining their manufacturing capabilities, certification standards, and market positioning.
Global Market for Selenium Sulfide: An Overview
The global demand for selenium sulfide has been growing steadily, driven by the prevalence of scalp disorders and increased awareness about scalp hygiene. The compound's production involves complex chemical synthesis and stringent quality controls, primarily supplied by specialized chemical manufacturers.
Selenium sulfide’s market is characterized by a limited number of key players owing to the specialized nature of its production and regulatory requirements. Most suppliers are located in Asia, Europe, and North America, with production geared towards pharmaceutical-grade standards.
Major Suppliers of Selenium Sulfide
1. Zhejiang Tianyu Pharmaceutical Co., Ltd. (China)
Zhejiang Tianyu is one of the leading producers of selenium-based products, including selenium sulfide. The company emphasizes pharmaceutical-grade quality, adhering to Good Manufacturing Practices (GMP). Their selenium sulfide is widely used in dermatological applications manufactured under strict quality controls.
- Capabilities: Large-scale synthesis, GMP-certified
- Certifications: ISO 9001, GMP
- Market Focus: Asia, emerging markets globally
2. TCI Chemicals, Inc. (Japan)
TCI is a prominent global supplier of specialty chemicals, including selenium compounds. Their selenium sulfide product line is recognized for purity and consistency, serving pharmaceutical and cosmetic industries worldwide.
- Capabilities: High-purity selenium sulfide, custom formulations
- Certifications: ISO 9001, ISO 14001
- Market Focus: North America, Europe, Asia
3. Spectrum Chemical Manufacturing Corp. (USA)
Spectrum Chemical specializes in fine chemicals, including selenium sulfide, tailored for pharmaceutical and cosmetic formulations. They emphasize reliability, purity, and regulatory compliance.
- Capabilities: Pharmaceutical-grade selenium sulfide, robust supply chain
- Certifications: cGMP, ISO 9001
- Market Focus: North America, Europe, Asia
4. Sigma-Aldrich (Merck Group) (Germany/Global)
Although primarily known for chemical reagents, Merck’s Sigma-Aldrich division supplies selenium sulfide for research and some pharmaceutical applications, ensuring high purity and consistent quality.
- Capabilities: High-specification chemicals, global distribution
- Certifications: ISO 9001, GMP (for select facilities)
- Market Focus: Global
5. Jiangsu Haimeng Pharmaceutical Co., Ltd. (China)
Specialized in the production of specialty chemicals, Jiangsu Haimeng supplies selenium sulfide to pharmaceutical and cosmetic manufacturers. Their products meet both domestic and international standards.
- Capabilities: Bulk supply, pharmaceutical-grade selenium sulfide
- Certifications: ISO 9001, GMP
- Market Focus: Asia, expanding to North America and Europe
Quality Standards and Regulatory Compliance
Given its pharmaceutical application, selenium sulfide suppliers must comply with stringent standards. These include:
- GMP Certification: Ensures product safety, consistency, and quality suitable for medicinal use.
- ISO Certifications: ISO 9001 for quality management systems and ISO 14001 for environmental management.
- Pharmacopoeial Standards: Suppliers often ensure their products meet USP, EP, or Ph. Eur. monographs to facilitate regulatory filings.
Regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require rigorous documentation and certification, making quality assurance crucial for suppliers.
Emerging Trends and Supply Chain Dynamics
- Consolidation and Vertical Integration: Some pharmaceutical giants are investing directly in raw material production or forming strategic alliances with selenium sulfide manufacturers to secure supply chains.
- Regulatory Harmonization: Suppliers are aligning their quality standards to meet global regulatory frameworks, easing market entry.
- Geopolitical Factors: Trade policies and tariffs influence manufacturing locations and logistics, impacting supply stability.
Key Considerations for Buyers
When selecting selenium sulfide suppliers, pharmaceutical companies should prioritize:
- Certification and Compliance: GMP, ISO, pharmacopoeial standards.
- Product Purity: High-purity grades (≥99%) to ensure safety and efficacy.
- Supply Reliability: Ability to meet large and consistent demand.
- Regulatory Support: Documentation for registration and compliance with local authorities.
- Environmental and Ethical Practices: Ensure sustainability and responsible sourcing.
Conclusion
A critical component of scalp therapeutics, selenium sulfide's supply chain is concentrated among a handful of reputable suppliers with strong regulatory adherence and manufacturing expertise. Companies seeking a reliable partner should focus on quality certifications, production capacity, and compliance with regulatory standards. Strategic sourcing from established suppliers can mitigate risks related to supply disruption and regulatory hurdles, ensuring continuous access to this vital pharmaceutical ingredient.
Key Takeaways
- Market Concentration: Few global suppliers dominate selenium sulfide production, mainly from China, Japan, Germany, and the USA.
- Quality Priority: Certification to GMP and pharmacopoeial standards is non-negotiable for pharmaceutical-grade supply.
- Supply Chain Risks: Geopolitical issues and regulatory changes necessitate diversified sourcing strategies.
- Regulatory Compliance: Suppliers with comprehensive regulatory documentation streamline product registration and market approval.
- Emerging Trends: Vertical integration and supply chain transparency are reshaping procurement strategies in this niche market.
FAQs
Q1: What are the main criteria for choosing a selenium sulfide supplier in pharmaceuticals?
A1: The primary criteria include product purity (≥99%), GMP and ISO certifications, supply reliability, regulatory compliance (e.g., USP, EP), and environmental sustainability practices.
Q2: Are there regional differences in selenium sulfide supplier standards?
A2: Yes, regulatory requirements vary; European and North American suppliers often adhere to stricter standards like GMP, whereas Asian suppliers are increasingly aligning with these standards to access global markets.
Q3: How do geopolitical factors influence selenium sulfide supply?
A3: Tariffs, trade restrictions, and regional policies can affect production locations, increasing costs or causing supply disruptions. Diversifying suppliers mitigates such risks.
Q4: Can pharmaceutical companies source selenium sulfide directly from chemical manufacturers?
A4: Yes, but they must verify certifications and supply chain reliability. Many prefer established suppliers with proven compliance to reduce regulatory hurdles.
Q5: What is the typical lead time for selenium sulfide procurement?
A5: Lead times generally range from 4 to 12 weeks, depending on supplier capacity, order size, and regulatory documentation required for specific markets.
References
- [1] MarketsandMarkets. "Pharmaceutical Ingredients Market." 2022.
- [2] European Pharmacopoeia. "Selenium Sulfide Specification." 2023.
- [3] U.S. Food and Drug Administration. "Good Manufacturing Practices (GMP)." 2022.
- [4] Zhejiang Tianyu Pharmaceutical Co., Ltd. Product brochure. 2023.
- [5] TCI Chemicals. Product Data Sheet. 2023.
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