Flucodel - 150 is a pharmaceutical formulation containing Fluconazole 150mg in tablet form, compliant with DPCO (Drug Price Control Order) regulations. The tablet is formulated using high-purity Fluconazole as the active pharmaceutical ingredient (API), combined with excipients such as microcrystalline cellulose, lactose, magnesium stearate, and colloidal silicon dioxide to ensure stability, disintegration, and uniformity. The formulation is designed to meet stringent pharmaceutical standards, including optimal dissolution rates, hardness, and weight variation. The manufacturing process employs advanced tableting technology to produce a robust, consistent dosage form suitable for long-term storage and stable distribution. The product’s chemical stability is ensured through controlled pH, moisture content, and packaging compatibility, making it ideal for pharmaceutical manufacturers requiring reliable raw materials for bulk production.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The production line includes high-speed tablet presses, automated packaging systems, and advanced quality control laboratories for real-time monitoring. Sterile processing capabilities are available for critical dosage forms, supported by Class 10,000 cleanroom environments. The facility is designed for scalability, enabling seamless transitions from small-scale trials to large-volume production without compromising quality. Quality systems include validated analytical methods, traceability protocols, and robust documentation to ensure compliance with regulatory requirements.
Available Strengths and Packaging
Flucodel - 150 is available in a single strength: Fluconazole 150mg Tab. (DPCO). The product is packaged in 30x1 Blister format, ensuring tamper-evident protection and convenient handling for pharmaceutical distributors. The blister packaging is compatible with automated dispensing systems and meets international standards for moisture barrier integrity and shelf-life stability.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our capabilities extend to full-scale production of finished dosage forms, with flexibility to accommodate custom specifications, labeling, and packaging requirements. We support global pharmaceutical buyers by providing end-to-end solutions, from API sourcing to finished product packaging, ensuring compliance with regional and international regulations. Our private label services enable clients to brand products under their own trademarks while maintaining strict quality control and regulatory adherence.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmacopeial standards. Each batch undergoes comprehensive testing for dissolution, disintegration, weight variation, and active ingredient content using HPLC and UV spectrophotometry. In-process controls and final product inspections ensure consistency and compliance with ICH, USP, and EP guidelines. We maintain detailed batch records, stability studies, and deviation management systems to guarantee product integrity. All quality control procedures are validated and documented to meet the requirements of regulatory authorities and pharmaceutical buyers.
Regulatory Compliance
Flucodel - 150 is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 standards. The product meets the requirements of the Indian Drug and Cosmetic Act, as well as international regulatory frameworks such as the US FDA, EMA, and PIC/S. Our facility is certified under ISO 17025 for testing laboratories and ISO 22000 for food safety management, ensuring adherence to global quality benchmarks. All documentation, including batch certificates, stability data, and regulatory filings, is prepared to support export compliance and market access in target regions.
Global Supply Capability
We provide robust global supply capabilities, including bulk export, international distribution networks, and reliable supply chain management. Our export-ready products are shipped via certified logistics partners to over 50 countries, with compliance to customs regulations and import documentation. Bulk supply capacity is scalable to meet large-volume demands, supported by inventory management systems and just-in-time production planning. Our supply chain ensures on-time delivery, reduced lead times, and minimal risk of disruptions, making us a preferred partner for pharmaceutical exporters and distributors.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our unmatched combination of quality, compliance, and scalability. Our DPCO-compliant Fluconazole 150mg tablets offer cost-effective bulk supply solutions with guaranteed purity and consistency. As a manufacturer with ISO and GMP certifications, we provide end-to-end support, from raw material sourcing to finished product packaging, ensuring seamless integration into your supply chain. Our commitment to regulatory compliance, rapid response times, and customized solutions makes us a reliable partner for global market access.
Bulk Supply Inquiry
For bulk supply inquiries, please contact info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking high-quality, compliant raw materials and finished products.
FAQs
What is the manufacturing standard for Flucodel - 150?
Flucodel - 150 is manufactured under cGMP and ISO 9001:2015 standards, ensuring compliance with global pharmaceutical regulations.
Can Flucodel - 150 be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademarks.
What excipients are used in Flucodel - 150?
The formulation includes microcrystalline cellulose, lactose, magnesium stearate, and colloidal silicon dioxide to ensure stability and uniformity.
Is Flucodel - 150 suitable for export to international markets?
Yes, the product meets WHO, FDA, EMA, and PIC/S guidelines, making it suitable for global export.
What is the packaging format for Flucodel - 150?
The product is packaged in **30x1 Blister** format, ensuring tamper-evident protection and ease of handling.
Can Flucodel - 150 be produced in bulk quantities?
Yes, our facility supports scalable production to meet bulk supply demands for pharmaceutical buyers.
What quality control tests are performed on Flucodel - 150?
Each batch undergoes dissolution, disintegration, weight variation, and HPLC/UV testing to ensure compliance with pharmacopeial standards.
How does your company ensure regulatory compliance?
We maintain full compliance with GMP, ISO 17025, and regional regulations, with documented processes for audit readiness.
What is the lead time for bulk orders?
Lead times vary based on order volume, but we prioritize rapid turnaround with pre-production planning for expedited delivery.
How can I request a sample or bulk supply?
Contact **info@delwishealthcare.com** for sample requests, bulk supply inquiries, or customized manufacturing solutions.
