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Suppliers and packagers for generic pharmaceutical drug: MICONAZOLE NITRATE
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MICONAZOLE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 079114 | ANDA | Target Corporation | 11673-199-00 | 1 KIT in 1 CARTON (11673-199-00) * 1 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE | 2010-07-08 |
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 079114 | ANDA | Rite Aid Corporation | 11822-1104-0 | 1 KIT in 1 CARTON (11822-1104-0) * 1 SUPPOSITORY in 1 POUCH (0113-3023-00) * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE | 2021-04-07 |
| Perrigo R And D | MICONAZOLE NITRATE | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 079114 | ANDA | Safeway | 21130-040-00 | 1 KIT in 1 CARTON (21130-040-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE | 2015-09-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Miconazole Nitrate
Introduction
Miconazole Nitrate is a broad-spectrum antifungal agent primarily used in the treatment of dermatophyte infections, candidiasis, and other superficial fungal infections. Its efficacy, safety profile, and affordability make it a staple in both prescription and over-the-counter antifungal formulations worldwide. For pharmaceutical companies, healthcare providers, and distributors, identifying reliable suppliers of pharmaceutical-grade Miconazole Nitrate is critical for ensuring supply chain integrity, regulatory compliance, and cost efficiency.
This article offers an in-depth analysis of key suppliers of Miconazole Nitrate, including their strengths, market presence, and compliance standards. It aims to assist industry stakeholders in making informed procurement and strategic sourcing decisions.
Global Suppliers and Manufacturers
1. Sigma-Aldrich / MilliporeSigma (Merck Group)
As one of the premier suppliers of pharmaceutical ingredients, Sigma-Aldrich offers high-purity Miconazole Nitrate for research and pharmaceutical manufacturing. Their manufacturing facilities are ISO-certified, ensuring strict adherence to quality standards such as USP, EP, and JP grades.
- Strengths: Extensive catalog, GMP-compliant manufacturing, reliable supply chain, rigorous quality controls.
- Market Presence: Global, with distribution channels spanning North America, Europe, and Asia.
Note: They primarily supply research-grade and pharmaceutical-grade chemicals, suitable for formulation and manufacturing purposes.
2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A prominent Chinese pharmaceutical manufacturer, Hisun Pharmaceutical is recognized for producing a broad range of active pharmaceutical ingredients (APIs), including Miconazole Nitrate.
- Strengths: Cost-competitive, large-scale production capacity, WHO GMP-certified.
- Market Presence: Strong in Asia; increasingly expanding into Latin America and Africa.
Regulatory Note: Products are compliant with the Chinese Pharmacopeia and often hold certificates suitable for export to international markets.
3. Indchemia (India)
Specialized in the production of antifungal agents, Indchemia supplies APIs for global pharmaceutical companies. Their Miconazole Nitrate is registered under various international pharmacopeias and is known for reliable quality.
- Strengths: Competitive pricing, strong R&D, adherence to cGMP standards.
- Market Presence: Robust presence in India, with exports to Europe, North America, and Southeast Asia.
4. TCI Chemicals (Japan)
Tokyo Chemical Industry Co., Ltd. supplies high-purity Miconazole Nitrate for research and development purposes, with some GMP-certified production lines for pharmaceutical use.
- Strengths: High-quality, research-grade material, advanced manufacturing techniques.
- Market Presence: Asia, North America, Europe.
5. Biosynth Carbosynth (UK/USA)
A global provider of specialty chemicals and building blocks for pharmaceuticals, Biosynth offers pharmaceutical-grade Miconazole Nitrate with comprehensive quality documentation.
- Strengths: Stringent quality controls, ISO-certified, extensive analytical support.
- Market Presence: North America, Europe, Asia.
Emerging and Regional Suppliers
6. Hubei Biocause Pharmaceutical Co., Ltd. (China)
A rapidly growing API producer, Hubei Biocause leverages modern manufacturing and quality controls to supply Miconazole Nitrate globally.
- Strengths: Competitive pricing, CFR and CIF shipping options.
- Regulatory Status: Complies with Chinese GMP; seeking international certifications.
7. Aarti Drugs Ltd. (India)
A well-established Indian pharmaceutical company with a focus on antifungal APIs, including Miconazole Nitrate. Their products meet various international pharmacopeias.
- Strengths: Cost-efficient production, long-standing market reputation.
- Market Focus: India, Africa, Middle East.
Regulatory and Quality Considerations
Choosing a supplier for Miconazole Nitrate must align with regulatory requirements pertinent to the target markets. Suppliers offering products registered with international standards such as USP, EP, or JP are preferable for formulations intended for developed markets. Additionally, GMP certification, batch analytical data, and stability reports are crucial documentation to verify product compliance and safety.
Market Trends and Procurement Strategies
The global antifungal API market is witnessing steady growth driven by increasing fungal infection incidences and expanding dermatological applications. Procurement strategies now emphasize customization, supply chain resilience, and regulatory compliance, pushing buyers toward suppliers with robust quality assurance and flexible logistics.
Emerging suppliers from China and India have gained prominence owing to their cost advantages and scalable manufacturing. However, global buyers should balance cost with quality assurance and regulatory support to mitigate risks associated with supply disruptions or non-compliance.
Key Suppliers Summary Table
| Supplier | Country | Certification & Standards | Market Focus | Notable Strengths |
|---|---|---|---|---|
| Sigma-Aldrich / MilliporeSigma | USA/Germany | USP, EP, JP, GMP | Global | Quality, reliability, extensive catalog |
| Zhejiang Hisun Pharmaceutical | China | GMP, WHO regulations | Asia, emerging markets | Cost-competitive, large capacity |
| Indchemia | India | cGMP, international pharmacopeias | Global | Cost-efficient, R&D focus |
| TCI Chemicals | Japan | Research & pharma-grade | Asia, North America | High purity, technological expertise |
| Biosynth Carbosynth | UK/USA | GMP, ISO certifications | Global | Analytical support, quality controls |
Conclusion
Securing a dependable supplier for Miconazole Nitrate entails evaluating factors like regulatory compliance, manufacturing standards, supply reliability, and cost. Leading global suppliers such as Sigma-Aldrich, Hisun Pharmaceutical, and Indchemia offer distinct advantages—whether it be premium quality, cost efficiency, or expansive capacity. Emerging regional manufacturers provide competitive alternatives, especially for large-volume or cost-sensitive projects.
Pharmaceutical companies must conduct meticulous supplier assessments, prioritize regulatory documentation, and foster strategic relationships to mitigate supply risks and ensure consistent access to high-quality Miconazole Nitrate.
Key Takeaways
- Leading suppliers like Sigma-Aldrich and Hisun Pharmaceutical ensure high-quality, GMP-compliant Miconazole Nitrate for global markets.
- Regional manufacturers from China and India offer cost-effective alternatives but require thorough quality validation.
- Regulatory compliance, including formal product registration and batch documentation, is crucial for international market access.
- Diversifying supply sources minimizes risks associated with geopolitical, logistical, or quality issues.
- Continuous monitoring of market trends and supplier performance is essential for strategic procurement.
FAQs
1. What are the primary considerations when sourcing Miconazole Nitrate?
Regulatory compliance, quality assurance, manufacturing capacity, cost, and supply chain reliability are key factors. Verify certifications such as GMP, USP, EP, or JP, and review analytical data and stability reports.
2. Are there major regional differences in suppliers of Miconazole Nitrate?
Yes, suppliers from North America and Europe generally adhere to stricter regulatory standards; however, Chinese and Indian manufacturers offer competitive pricing and large-scale production, necessitating careful validation for quality and compliance.
3. How can buyers verify the quality of Miconazole Nitrate from new suppliers?
Request comprehensive analytical reports, Certificate of Analysis (CoA), regulatory certificates, and, if possible, conduct on-site audits or third-party laboratory testing.
4. Is Miconazole Nitrate available in different grades?
Yes, typically research-grade, pharmaceutical-grade, and active pharmaceutical ingredient (API) grades. For formulation purposes, pharmaceutical-grade with GMP certification is preferred.
5. What are future market outlooks for Miconazole Nitrate suppliers?
The antifungal API market is expected to grow steadily, driven by increasing prevalence of fungal infections. Suppliers with validated manufacturing processes, strong regulatory support, and flexible logistics will be well-positioned to capitalize on this growth.
References
[1] European Pharmacopoeia (EP). Miconazole Nitrate monograph.
[2] U.S. Pharmacopeia (USP). Miconazole Nitrate monograph.
[3] Market data on antifungal APIs, IQVIA, 2022.
[4] International supplier certifications, Merck Group & major Chinese and Indian API manufacturers.
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