Suppliers and packagers for generic pharmaceutical drug: SERTACONAZOLE NITRATE

SERTACONAZOLE NITRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Bausch Health US, LLC	0187-5115-60	1 TUBE in 1 CARTON (0187-5115-60) / 60 g in 1 TUBE	2003-12-10
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Lacer Pharma, LLC	73159-004-60	1 TUBE in 1 CARTON (73159-004-60) / 60 g in 1 TUBE	2024-11-26
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Coral Way Pharma, LLC	85437-004-60	1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE	2025-11-07

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: SERTACONAZOLE NITRATE

Introduction
Sertaconazole nitrate is an azole antifungal agent used primarily for dermatological conditions such as tinea infections, candidiasis, and other superficial fungal infections. The global demand for Sertaconazole nitrate has increased due to its efficacy and favorable pharmacokinetics. Identifying reliable suppliers is crucial for pharmaceutical companies seeking to ensure quality, compliance, and timely procurement of this active pharmaceutical ingredient (API). This comprehensive review details the key suppliers, their manufacturing footprints, regulatory standing, and market positioning within the Sertaconazole nitrate supply chain.

Global Landscape of Sertaconazole Nitrate Suppliers

1. Major Manufacturers and Regional Market Presence
Several pharmaceutical ingredient manufacturers produce Sertaconazole nitrate, with a concentration in Asia—particularly India and China—as these regions dominate generic API manufacturing due to cost efficiencies and extensive R&D infrastructure. Noteworthy suppliers include:

• SinoPharmChem (China)
  SinoPharmChem is among the leading API manufacturers specializing in antifungal agents. Their Sertaconazole nitrate production facilities are cGMP-compliant, with ISO certifications ensuring product quality and consistency. The company's extensive reactor capacity and robust supply chain enable they to serve global markets, including North America, Europe, and Asia.

• Hangzhou Minshui Pharmaceutical (China)
  As a key Chinese API manufacturer, Minshui Pharma offers Sertaconazole nitrate with ISO 9001 and ISO 14001 certifications. Their strategic partnerships with domestic and international pharmaceutical companies facilitate large-volume supplies, supporting both generics and branded formulations.

• Hunan Zaan Pharmaceutical (China)
  Zaan Pharmaceutical specializes in antifungal APIs. Their Sertaconazole nitrate is marketed broadly within Asia, with growing exports to Europe. The company emphasizes rigorous quality control aligned with GMP standards, supporting their reputation in the global supply chain.

• Sun Pharmaceutical Industries (India)
  As one of the largest Indian pharmaceutical companies, Sun Pharma has invested heavily in API manufacturing, including antifungals. While primarily known for finished formulations, they also produce high-quality Sertaconazole nitrate APIs for export, adhering to international regulatory standards such as USFDA and EMA approvals.

• Torrent Pharmaceuticals (India)
  With a substantial API manufacturing footprint, Torrent has developed a reputation for reliable antifungal APIs, including Sertaconazole nitrate, complying with global regulatory benchmarks to meet the requirements of multinational clients.

2. Specialty API Suppliers and Contract Manufacturing Organizations (CMOs)
In addition to large pharmaceutical companies, several CMOs and specialist API suppliers provide Sertaconazole nitrate through contract manufacturing and custom synthesis services. These organizations include:

• Glenmark Pharmaceuticals (India)
  Known for R&D and API manufacturing, Glenmark supplies Sertaconazole nitrate to partners within the global pharmaceutical industry, leveraging advanced synthesis processes.

• Faisalabad-based Contract Manufacturing Firms (Pakistan)
  Some smaller firms in Pakistan offer Sertaconazole nitrate, focusing on competitive pricing and flexible supply options, although their regulatory compliance and quality certifications vary.

• Sigma-Aldrich/Merck (Global)
  While primarily a supplier of research-grade compounds, Merck provides pharmaceutical-grade Sertaconazole nitrate for research and clinical development, which may serve as geographic or technical backups until commercial-grade sources are secured.

3. Regulatory and Quality Considerations
Quality assurance is paramount for Sertaconazole nitrate suppliers. ISO 9001, cGMP, and other certifications signal regulatory compliance, but due diligence must include review of batch consistency, purity levels (>99%), and stability data. Several suppliers have obtained WHO-GMP certification, facilitating their acceptance in regulated markets such as the US, EU, and Japan. For example, Sun Pharma's API manufacturing facilities are inspected regularly by USFDA and EMA authorities, ensuring compliance standards are met or exceeded.

Supply Chain Challenges and Risks
While the Asian market dominates Sertaconazole nitrate production, supply chain disruptions—such as geopolitical issues, raw material shortages, and logistical delays—pose risks. The COVID-19 pandemic highlighted vulnerabilities in global API supply chains, emphasizing the necessity for diversified sourcing and inventory buffers. Moreover, increasing regulatory scrutiny necessitates rigorous quality documentation, certification, and compliance to avoid delays or rejections during registration processes.

Emerging Trends and Market Dynamics

• Focus on Quality and Compliance
  Suppliers are investing in process improvements and accreditation to meet stringent international regulatory standards, especially for exports to US and European markets.

• Manufacturing Consolidation and Alliances
  Strategic partnerships and collaborations are emerging to enhance supply stability and expand capacity, reducing dependency on single sources.

• Regulatory Certifications and Market Access
  API suppliers with WHO-GMP, USFDA, or EMA-approved facilities enjoy competitive advantages, gaining easier access to highly regulated markets.

• Bioequivalence and Formulation Partnerships
  Some suppliers are expanding into formulation partnerships or offering APIs tailored for specific delivery systems, addressing niche dermatological market needs.

Conclusion
The global Sertaconazole nitrate supply chain is characterized by numerous suppliers primarily located in China and India. Leading manufacturers such as SinoPharmChem, Hangzhou Minshui Pharma, Sun Pharma, and Torrent Pharmaceuticals dominate the landscape, backed by stringent quality control, regulatory compliance, and global distribution networks. For pharmaceutical companies, choosing the right supplier hinges on balancing cost, quality, regulatory compliance, and supply reliability. As regulatory environments tighten and supply chain resilience becomes a priority, diversification and engagement with suppliers holding quality certifications will be critical to secure dependable sourcing of Sertaconazole nitrate.

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Key Takeaways

• The global API market for Sertaconazole nitrate is concentrated mainly in China and India, with prominent companies meeting international standards.
• Regulatory certifications such as WHO-GMP, USFDA, and EMA approval are crucial for access to regulated markets.
• Supply chain risks necessitate diversification, inventory management, and ongoing supplier qualification.
• Strategic partnerships with CMOs and high-quality manufacturers can optimize supply stability and compliance.
• Technological advancements in synthesis and process automation are likely to improve product purity, cost-efficiency, and regulatory acceptance over time.

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FAQs

1. How do I verify the regulatory compliance of Sertaconazole nitrate suppliers?
Verify certifications such as WHO-GMP, USFDA approval, and EMA certification. Review third-party audits, batch records, and compliance documentation. Engage in supplier audits and request reference quality reports.

2. What factors should be considered when sourcing Sertaconazole nitrate?
Focus on product purity (>99%), batch-to-batch consistency, regulatory compliance, manufacturing capacity, lead times, and past quality track record.

3. Are there any known supply shortages of Sertaconazole nitrate?
Supply shortages are intermittent, often driven by raw material availability, regulatory inspections, or manufacturing disruptions, highlighting the need for diversified sourcing strategies.

4. How does the price of Sertaconazole nitrate vary globally?
Pricing depends on supplier location, certification, quantity, and market demand. Typically, Chinese suppliers offer more competitive pricing due to lower production costs, but quality assurance remains paramount.

5. What is the outlook for new entrants into the Sertaconazole nitrate supply market?
Emerging producers focusing on high-quality, compliant manufacturing with advanced process technology and strategic partnerships are poised to capture market share, especially as demand grows.

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References
[1] Global API Market Analysis Reports, 2022.
[2] USFDA API Inspection Reports, 2023.
[3] WHO-GMP Certified API Manufacturers Directory, 2023.
[4] Industry white paper: Trends in Antifungal API Manufacturing, Pharmaceutical Tech, 2022.
[5] Company websites and public filings.