Fungazole-B Cream is a stabilized topical formulation combining clotrimazole, a broad-spectrum antifungal agent, with beclomethasone dipropionate, a potent corticosteroid. The formulation is designed to ensure optimal compatibility, stability, and uniform dispersion of active ingredients. Clotrimazole, a synthetic imidazole derivative, provides antifungal activity by inhibiting ergosterol synthesis in fungal cell membranes. Beclomethasone dipropionate, a long-acting glucocorticoid, is formulated to deliver sustained anti-inflammatory and immunosuppressive effects. The base formulation employs a water-in-oil emulsion system to enhance skin penetration and prolong therapeutic action. Excipients such as emulsifiers, preservatives, and pH regulators are incorporated to maintain product integrity and ensure shelf stability. The combination of these components is engineered to meet stringent pharmaceutical standards, ensuring consistent performance across manufacturing batches.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and designed for the production of high-quality topical formulations. The facility includes dedicated sterile processing zones for sensitive active pharmaceutical ingredients (APIs) and advanced mixing, homogenization, and packaging systems. Automated quality control measures ensure precise dosing and uniform dispersion of active components. The production process adheres to rigorous validation protocols, including process analytical technology (PAT) for real-time monitoring. Scalability is achieved through modular production lines capable of handling bulk orders while maintaining consistency in product quality. Comprehensive quality systems, including documented standard operating procedures (SOPs) and trained personnel, ensure adherence to regulatory requirements and operational efficiency.
Available Strengths and Packaging
Fungazole-B Cream is available in a single strength formulation: Clotrimazole 1.0% + Beclomethasone Dipropionate 0.025%. The product is packaged in 20gm containers, ensuring convenient handling and distribution for pharmaceutical buyers. The packaging design prioritizes stability, with airtight closures to preserve active ingredient potency and prevent contamination.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our capabilities include formulation development, API integration, and finished product manufacturing, with flexibility to accommodate custom specifications. We support private label manufacturing for brand-specific requirements, ensuring compliance with regulatory standards and quality benchmarks. Our team collaborates closely with clients to optimize production timelines, reduce costs, and maintain product consistency. Whether you require small-scale trials or large-volume commercial production, our scalable infrastructure and expertise in pharmaceutical manufacturing ensure seamless delivery of high-quality products.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and compliance with international pharmaceutical standards. Every batch undergoes in-process testing for pH, viscosity, and active ingredient content, followed by final batch testing for homogeneity, microbial limits, and sterility where applicable. Advanced analytical techniques, including high-performance liquid chromatography (HPLC) and UV spectrophotometry, validate the purity and potency of active components. Quality control systems are integrated with Good Laboratory Practice (GLP) protocols to ensure data integrity and traceability. We maintain detailed batch records and conduct periodic audits to ensure adherence to ICH, USP, and EP guidelines.
Regulatory Compliance
Fungazole-B Cream is manufactured in full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001:2015 quality management standards. Our facility is certified by regulatory authorities in multiple regions, ensuring adherence to local and international requirements. We maintain documentation aligned with FDA, EMA, and PIC/S guidelines, enabling seamless regulatory submissions for market approval. Our commitment to compliance extends to environmental and safety standards, with continuous improvement programs to meet evolving regulatory expectations.
Global Supply Capability
We provide robust global supply capabilities, including export-ready manufacturing, international distribution networks, and bulk supply solutions. Our logistics partners ensure timely delivery to over 50 countries, with customized packaging and shipping options to meet regional requirements. Bulk supply capacity is supported by scalable production lines and inventory management systems, ensuring uninterrupted supply chains. We prioritize supply chain reliability through redundant systems, real-time tracking, and contingency planning, minimizing risks of delays or disruptions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality formulation development, regulatory compliance, and scalable production. Our competitive advantages include a proven track record of delivering consistent product quality, cost-effective manufacturing solutions, and rapid time-to-market capabilities. We prioritize client collaboration, offering tailored support to meet specific business needs. With a focus on innovation, compliance, and reliability, we enable partners to achieve market success while adhering to global standards.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com. Our dedicated sales and technical support team is ready to assist with order placement, customization, and supply chain coordination.
FAQs
What manufacturing standards does Fungazole-B Cream comply with?
Fungazole-B Cream is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global regulatory requirements.
Can Fungazole-B Cream be produced in bulk quantities?
Yes, our facility supports bulk production with scalable manufacturing capabilities to meet large-volume orders.
What is the shelf life of Fungazole-B Cream?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does Fungazole-B Cream require special storage conditions?
The cream should be stored at temperatures between 15–30°C, away from moisture and direct sunlight.
Can Fungazole-B Cream be customized for private label manufacturing?
Yes, we offer private label manufacturing services to meet brand-specific requirements.
What quality control measures are in place for Fungazole-B Cream?
Each batch undergoes rigorous testing for pH, active ingredient content, microbial limits, and sterility.
Is Fungazole-B Cream approved for international markets?
Our compliance with global regulatory standards enables export to over 50 countries.
How does your company ensure supply chain reliability?
We maintain redundant systems, real-time tracking, and contingency planning to ensure uninterrupted supply.
Can Fungazole-B Cream be produced with alternative packaging formats?
Yes, we offer flexibility in packaging design to meet specific distribution and regulatory requirements.
What is the minimum order quantity for Fungazole-B Cream?
The minimum order quantity is 1,000 units, with options for smaller trial batches upon request.
