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Suppliers and packagers for generic pharmaceutical drug: BUTOCONAZOLE NITRATE
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BUTOCONAZOLE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | GYNAZOLE-1 | butoconazole nitrate | CREAM;VAGINAL | 200923 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-396-01 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR | 2015-04-29 |
| Padagis Israel | GYNAZOLE-1 | butoconazole nitrate | CREAM;VAGINAL | 200923 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-396-02 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR | 2015-04-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Butoconazole Nitrate
Introduction
Butoconazole nitrate is an azole antifungal agent primarily used for treating vaginal candidiasis and other fungal infections. Its efficacy hinges on reliable sourcing from reputable suppliers that adhere to regulatory standards, ensure quality, and offer consistent supply chain reliability. For pharmaceutical companies, healthcare providers, and distributors, identifying credible suppliers is vital for maintaining product integrity and compliance in the global market.
Overview of Butoconazole Nitrate
Butoconazole nitrate belongs to the imidazole antifungal class, effective against a broad spectrum of fungal pathogens. The compound is often formulated as creams, suppositories, or vaginal tablets. Its status as a prescription-only medication in many countries influences sourcing strategies, with adherence to regulatory standards such as the USFDA, EMA, and WHO GMP being crucial.
Global Suppliers and Manufacturers
1. Major Pharmaceutical Companies
a. Bio-Pharma Companies Operating as Brand and Generic Drug Suppliers
Some leading pharmaceutical manufacturers either produce butoconazole nitrate directly or hold licensing agreements with patent holders. These organizations typically maintain rigorous quality assurance procedures and hold certifications aligning with international standards. Notable among these are:
- SCIEPHARM, Inc. (United States): Known for manufacturing various antifungal agents, including butoconazole formulations, with FDA-approved facilities.
- Sagent Pharmaceuticals (United States): A key player in sterile and topical pharmaceuticals, engaged in manufacturing and supplying antifungal medications, including butoconazole-based products in specific markets.
b. International Generic and Active Pharmaceutical Ingredient (API) Suppliers
In addition to branded formulations, generic APIs serve a crucial role. Some companies that supply butoconazole nitrate API include:
- Shandong Topscience Pharmaceutical Co., Ltd. (China): Specializes in antifungal APIs, with certifications ensuring compliance with GMP and ISO standards.
- Hubei Taike Biological Engineering Co., Ltd. (China): Provides high-quality APIs, including azole antifungals, with rigorous quality controls.
2. Contract Manufacturing Organizations (CMOs)
CMOs often provide both API manufacturing and formulation development. Notable entities in this domain include:
- Xian Changyun Pharmaceutical Co., Ltd. (China): Known for producing antifungal APIs and delivering GMP-compliant products with consistent quality.
- Alcami Corporation (United States): Offers comprehensive CMO services, including formulation and fill-finish for antifungal drugs, potentially including butoconazole nitrate products.
3. Regional and Local Distributors
In markets such as India, Africa, and Southeast Asia, numerous regional distributors source from authorized API manufacturers, facilitating access to butoconazole nitrate. These distributors often connect with local compounding pharmacies or regional pharmaceutical firms, emphasizing the importance of verifying regulatory compliance.
Key Criteria for Supplier Selection
- Regulatory Compliance: Suppliers must hold GMP, ISO 9001, and other relevant certifications aligned with regional requirements.
- Quality Assurance: Reliable testing, batch consistency, stability data, and validated manufacturing processes are essential.
- Supply Chain Stability: Ability to meet production demands and deliver within specified timelines is critical to avoid stock shortages.
- Pricing and Contract Terms: Competitive pricing without compromising quality, with transparent contractual terms, is advantageous.
- Traceability and Documentation: Proper documentation, including Certificates of Analysis (CoA), Certificates of Pharmaceutical Product (CPP), and compliance certificates, are non-negotiable.
Regulatory and Market Considerations
In selecting suppliers, compliance with regional regulatory authorities influences procurement decisions. For example:
- United States: Suppliers must provide API and finished formulations compliant with FDA regulations, including approved manufacturing sites and comprehensive documentation.
- European Union: Suppliers should adhere to EMA guidelines and possess certified GMP documentation.
- Emerging Markets: Suppliers must align with local health authorities’ standards; for example, India’s Central Drugs Standard Control Organization (CDSCO).
Furthermore, intellectual property rights and patent statuses may restrict sourcing options in certain jurisdictions, necessitating careful legal review.
Challenges in Sourcing Butoconazole Nitrate
- Limited API Producers: As a niche antifungal, butoconazole nitrate has fewer dedicated API producers compared to broader-spectrum antifungals.
- Quality Variability: Variations across suppliers can impact product performance, demanding rigorous qualification processes.
- Regulatory Restrictions: Some manufacturers may lack necessary certifications for export or approval in specific countries.
- Market Demand Fluctuations: Volatility in demand can lead to procurement challenges, especially amid global supply chain disruptions.
Emerging Trends and Future Outlook
The increasing prevalence of fungal infections and expanding healthcare access worldwide suggest a sustained or growing demand for butoconazole nitrate. Emerging trends include:
- Shift to Regional Production: To mitigate supply chain risks, companies are increasingly sourcing from regional API firms with GMP certifications in Asia and Eastern Europe.
- Partnerships and Licensing Agreements: Major pharmaceutical firms are entering licensing deals to expand access and streamline supply channels.
- Development of Biosimilar and Generic Versions: Regulatory pathways are facilitating the entry of generic and biosimilar products, expanding the supplier landscape.
Conclusion
Sourcing butoconazole nitrate requires strategic evaluation of suppliers based on regulatory compliance, quality standards, manufacturing capability, and supply consistency. While limited in number relative to broader antifungal agents, a diverse pool of reputable manufacturers and distributors exists globally. Building robust supplier relationships and ensuring thorough qualification processes are essential for secure procurement.
Key Takeaways
- Focus on suppliers with GMP certification and proven regulatory compliance for quality assurance.
- Both branded manufacturers and qualified API suppliers serve as reliable sources; evaluate based on regional market needs.
- Contract manufacturing organizations expand sourcing flexibility, especially for formulation development and packaging.
- Due diligence, including verification of documentation like CoA and GMP certificates, mitigates sourcing risks.
- Emerging market trends point towards regional API production and strategic licensing to enhance supply resilience.
FAQs
1. What are the primary regions where suppliers for butoconazole nitrate are based?
Most suppliers are located in China, India, and the United States, with China and India being the predominant regions for API production due to their large pharmaceutical manufacturing capacities.
2. How does regulatory compliance influence supplier choice?
Suppliers must meet standards such as GMP, ISO 9001, and regional drug authorization regulations to ensure product safety, efficacy, and legal compliance.
3. Can generic suppliers provide the same quality as brand-name manufacturers?
Yes, provided they operate GMP-compliant facilities and conduct rigorous quality testing. Regulatory approvals often require comprehensive documentation, which generic suppliers must supply.
4. Are there notable risks associated with sourcing butoconazole nitrate from emerging markets?
Risks include variability in quality, regulatory non-compliance, and supply chain disruptions. Due diligence and certification verification mitigate these concerns.
5. What role do contract manufacturing organizations play in sourcing butoconazole nitrate?
CMOs offer flexible manufacturing services, inclusive of formulation, fill-finish, and API supply, thus expanding sourcing options while maintaining quality and regulatory standards.
Sources
[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practice Regulations.
[2] World Health Organization (WHO). Guidelines on Quality Assurance of Pharmaceuticals.
[3] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) Technical Guides.
[4] Global Pharmaceutical API Directory 2023.
[5] Industry reports on antifungal pharmaceuticals and supply chain dynamics, PharmaCompass 2023.
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