Share This Page
Suppliers and packagers for generic pharmaceutical drug: miconazole
✉ Email this page to a colleague
miconazole
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Galt Pharms | ORAVIG | miconazole | TABLET;BUCCAL | 022404 | NDA | Galt Pharmaceuticals, LLC | 61825-303-14 | 14 TABLET in 1 BOTTLE (61825-303-14) | 2021-12-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Miconazole
Introduction
Miconazole is a broad-spectrum antifungal agent employed predominantly in the treatment of various superficial fungal infections, including dermatophyte infections, candidiasis, and tinea infections. Its significance in both prescription and over-the-counter pharmaceutical markets underscores the importance of a robust supplier network. Identifying reliable suppliers is critical for pharmaceutical companies, healthcare providers, and distributors to ensure a consistent supply of high-quality miconazole products. This article provides an in-depth analysis of major suppliers, manufacturing players, and supply chain considerations within the miconazole market.
Global Market Dynamics and Demand for Miconazole
The global antifungal market, valued at approximately USD 11 billion in 2022 [1], projects steady growth driven by increasing prevalence of fungal infections, rising awareness, and expanding dermatological treatment protocols. Miconazole forms a core element of this landscape, primarily supplied as topical creams, ointments, sprays, and oral formulations.
Market drivers include:
- Growing incidence of dermatological fungal infections due to urbanization and climate factors.
- Expanded OTC availability in developing regions.
- Healthcare system focus on antifungal prophylaxis for immunocompromised patients.
Given this growth, reliable procurement channels are vital. The supply of miconazole largely depends on chemical manufacturers producing active pharmaceutical ingredients (APIs) and finished dosage formulations.
Major Suppliers of Miconazole Active Pharmaceutical Ingredient (API)
1. Zhongxi Pharmaceutical Co., Ltd. (China)
Zhongxi Pharmaceutical is among the leading manufacturers of miconazole API. Located in China, it benefits from a robust chemical manufacturing infrastructure. The company emphasizes quality control, cGMP compliance, and competitive pricing. Zhongxi exports to numerous countries, including India, Southeast Asia, and parts of Latin America, making it a significant supplier in the global market.
2. Hindustan Organic Chemicals Ltd. (India)
Hindustan Organic Chemicals Ltd. (HOC) is a government-owned Indian enterprise with a track record in producing a variety of organic chemicals, including miconazole API. Its strategic focus on affordability and quality has established it as a domestic and regional supplier, especially serving the Indian pharmaceutical market.
3. Zhejiang Xianju Pharmaceutical Co., Ltd. (China)
Specializing in antifungal APIs, Zhejiang Xianju Pharmaceutical has expanded its production capacity for miconazole. Its facilities are cGMP-certified, and it supplies to clients across Asia, the Middle East, and Africa.
4. Zhejiang Medicine Co., Ltd. (China)
Zhejiang Medicine develops and produces various pharmaceutical APIs, including miconazole. The company's vertically integrated manufacturing process ensures quality control, and it holds export licenses in multiple jurisdictions.
5. LGC Limited (UK)
LGC, a global provider of reference standards and quality control solutions, supplies pharmaceutical-grade miconazole APIs certified for quality and purity. While primarily a provider of standards, LGC collaborates with manufacturers for supply chain assurance.
Leading Finished Dosage Form Suppliers and Contract Manufacturing Organizations (CMOs)
While API manufacturers are critical, many pharmaceutical companies rely on CMOs for formulation and production of final miconazole products.
1. Dr. Reddy’s Laboratories (India)
A prominent global pharmaceutical company, Dr. Reddy’s manufactures a broad range of antifungal products, including miconazole topical formulations. Their manufacturing facilities are cGMP-compliant, and they serve international markets through strategic partnerships.
2. Cipla Ltd. (India)
Cipla is OEM and OTC supplier of miconazole-based products, particularly topical creams and powders. Their extensive distribution network ensures widespread availability in India, Africa, and emerging markets.
3. Mylan (US/North America)
Mylan, now part of Viatris, produces miconazole-based antifungals for North American markets. Their global manufacturing footprint ensures supply security and regulatory compliance.
4. Famar Pharma (Greece)
Famar supplies contract manufacturing services for antifungal formulations, including miconazole topical creams, to European clients. Their robust quality systems meet strict EU standards.
5. Piramal Pharma Solutions (India)
Piramal offers contract manufacturing services for antifungal APIs and formulations, serving both regional and global clients with high-quality standards.
Key Considerations in Supplier Selection
- Regulatory compliance: Suppliers must adhere to cGMP, ISO standards, and possess necessary certifications (e.g., US FDA, EU EMA).
- Quality assurance: Proven quality control measures, stability data, and batch consistency are vital.
- Pricing and lead times: Competitive pricing coupled with reliable delivery schedules influences procurement strategy.
- Capacity and scalability: Suppliers must meet current demand and have scalability for future growth.
- Geographical presence: Regional suppliers help mitigate supply chain disruptions and facilitate faster delivery.
Supply Chain Challenges and Opportunities
The sourcing of miconazole faces challenges including geopolitical tensions, raw material shortages, and manufacturing bottlenecks, especially amid disruptions caused by the COVID-19 pandemic. Suppliers investing in diversification, traceability, and technology-driven quality improvements can capitalize on emerging market opportunities.
Treatment protocols increasingly favor topical formulations, which demand consistent API quality. As such, pharmaceutical companies seek suppliers with proven track records, especially in ensuring regulatory compliance across jurisdictions.
Emerging Trends in Miconazole Supply
- Shift towards biosimilar and generic markets: Increased competition from low-cost Asian manufacturers.
- Vertical integration: Companies vertical integration models improve supply security.
- Sustainable manufacturing practices: Incorporation of environmentally friendly processes and greener chemical synthesis methods.
- Digital supply chain management: Use of blockchain and digital tools to enhance traceability and transparency.
Conclusion
The supply landscape for miconazole is characterized by a mix of established Asian manufacturers, regional producers, and global CMOs. Chinese companies dominate API production given their scale and cost advantages, while Indian firms like Dr. Reddy’s and Cipla play significant roles in formulation manufacturing. Ensuring quality, regulatory compliance, and supply chain resilience remains paramount for procurement strategies in this market.
Key Takeaways
- China dominates the API manufacturing sector for miconazole, with notable players including Zhongxi Pharmaceutical and Zhejiang Xianju Pharmaceutical.
- Indian pharmaceutical companies such as Dr. Reddy’s and Cipla are leading suppliers in finished dosage forms and formulations.
- Suppliers must demonstrate compliance with GMP, ISO, and regional regulatory standards, especially for global distribution.
- Diversification of suppliers and regions reduces risks associated with geopolitical and logistical disruptions.
- Innovations in sustainable practices and digital traceability further enhance supply chain robustness.
FAQs
1. Who are the top global suppliers of miconazole API?
Chinese manufacturers such as Zhongxi Pharmaceutical and Zhejiang Xianju Pharmaceutical dominate, supported by Indian companies like Hindustan Organic Chemicals.
2. What regulatory standards should suppliers of miconazole meet?
Suppliers should comply with cGMP (current Good Manufacturing Practice), ISO standards, and hold certifications like FDA approval or EU EMA compliance for quality assurance.
3. How can companies ensure a reliable supply of miconazole?
By establishing multi-source procurement strategies, selecting suppliers with proven quality records, and maintaining inventory buffers to mitigate disruptions.
4. Are there regional differences in miconazole suppliers?
Yes, Chinese manufacturers supply primarily Asian and African markets, while Indian companies serve domestic and nearby markets, with some exporting globally.
5. What upcoming trends could impact the miconazole supply chain?
Growing interest in biosimilars, sustainable manufacturing, and digital supply chain management are poised to influence future procurement strategies and supplier choices.
Sources
- Market Research Future. (2022). Global Antifungal Market Report.
More… ↓
