Fluconit 200 is formulated as a solid dosage form containing 200mg of Fluconazole, a triazole antifungal agent, combined with excipients such as lactose, magnesium stearate, and microcrystalline cellulose. The tablet is designed for optimal stability, bioavailability, and dissolution characteristics, ensuring consistent therapeutic performance. The formulation adheres to strict pharmaceutical guidelines, with a focus on uniform particle size, compression efficiency, and tablet hardness to meet mechanical and chemical stability requirements. The excipients are carefully selected to ensure compatibility with the active ingredient, prevent degradation, and support the tablet’s integrity during storage and transportation. The product’s pharmaceutical characteristics include a pH-neutral environment, low moisture content, and resistance to environmental stressors, ensuring long-term shelf stability.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce high-quality pharmaceutical products like Fluconit 200. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a sterile processing environment for blister packaging, ensuring contamination-free production. Advanced tablet compression machines and coating systems are employed to achieve precise dosing and uniform tablet dimensions. The production line is scalable to meet bulk supply demands, with capabilities for large-scale manufacturing while maintaining strict quality control. Our quality systems include real-time monitoring of critical parameters such as temperature, humidity, and particle size distribution during formulation. Additionally, the facility is certified under ISO 9001 and ISO 14001 standards, ensuring compliance with environmental and operational excellence benchmarks.
Available Strengths and Packaging
Composition: Fluconazole 200mg Tab
Packaging: 25x1 Blister
Fluconit 200 is available in a single strength of 200mg, designed for broad therapeutic applications. The blister packaging format ensures secure, tamper-evident storage and easy dispensing, with each blister containing one tablet. The 25x1 blister pack is optimized for retail and institutional use, offering convenience and cost-efficiency for bulk supply.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where clients can brand the product under their own name while leveraging our expertise in formulation and production. We also provide contract manufacturing for generic and branded pharmaceuticals, ensuring compliance with global regulatory standards. Our flexible production model allows customization of packaging formats, dosage strengths, and labeling to meet specific market requirements. For third-party manufacturing, we maintain strict confidentiality agreements and adhere to client specifications, ensuring seamless integration into existing supply chains.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product consistency and safety. Every batch of Fluconit 200 undergoes rigorous testing, including physicochemical analysis, dissolution testing, and microbial limit checks. Analytical validation is performed using advanced techniques such as HPLC (High-Performance Liquid Chromatography) and UV spectroscopy to confirm potency and purity. Batch testing includes assessments for tablet hardness, disintegration time, and friability to ensure mechanical integrity. Our quality control protocols comply with ICH, USP, and EP guidelines, ensuring alignment with international pharmaceutical standards. Additionally, we maintain detailed documentation for traceability and regulatory audits, supporting compliance with global quality frameworks.
Regulatory Compliance
Fluconit 200 is manufactured in full compliance with GMP, WHO guidelines, ISO 9001, and ISO 14001 standards. Our facility is registered with regulatory authorities in multiple jurisdictions, including the FDA, EMA, and WHO, ensuring adherence to global quality and safety benchmarks. The product meets specifications for active pharmaceutical ingredients (APIs) and excipients as outlined in ICH Q3A and Q3B guidelines. We also comply with environmental regulations, ensuring sustainable manufacturing practices and waste management protocols. Our documentation and audit trails support regulatory submissions, enabling seamless market access in both developed and emerging markets.
Global Supply Capability
We provide robust global supply capabilities, including export-ready manufacturing, international distribution networks, and bulk supply options. Our logistics partnerships ensure timely delivery to over 50 countries, with a focus on reliability and compliance. The 25x1 blister packaging format is compatible with global distribution channels, supporting both retail and institutional markets. Our bulk supply capacity is designed to meet large-scale demand, with flexible order quantities and just-in-time production to optimize inventory management. We maintain a resilient supply chain infrastructure, with contingency plans to address disruptions and ensure uninterrupted delivery.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our unwavering commitment to quality, compliance, and scalability. Our expertise in GMP-certified manufacturing ensures consistent product standards, while our global regulatory compliance framework simplifies market entry. We offer competitive pricing without compromising on quality, making us an ideal partner for bulk supply and private label manufacturing. Our dedicated customer support team provides end-to-end assistance, from formulation development to logistics coordination. With a proven track record in delivering high-quality pharmaceutical products, we empower partners to meet market demands efficiently and reliably.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with customized solutions, including large-scale production, packaging adjustments, and regulatory support for global distribution.
FAQs
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and ISO 14001, ensuring compliance with global pharmaceutical and environmental standards.
Can you customize packaging formats for Fluconit 200?
Yes, we offer flexible packaging options, including blister packs, strips, and bulk containers, to meet specific market requirements.
What quality control measures are in place for Fluconit 200?
Each batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial analysis, to ensure potency, purity, and safety.
Are you compliant with WHO and FDA regulations?
Yes, our manufacturing processes and documentation align with WHO guidelines, FDA regulations, and other international standards.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible quantities to suit your business needs.
How long does the production and delivery process take?
Production timelines vary based on order size, but we ensure timely delivery through our efficient supply chain and logistics partnerships.
Can you provide documentation for regulatory submissions?
Yes, we supply complete documentation, including batch certificates, analytical reports, and compliance certificates for global regulatory submissions.
What is your export capability for Fluconit 200?
We have a proven export network covering over 50 countries, with compliance-ready products for international markets.
Do you support private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own name.
How do you ensure supply chain reliability?
Our robust supply chain includes contingency planning, real-time tracking, and partnerships with trusted logistics providers to ensure uninterrupted delivery.
