Fusac-M Cream is a dual-action topical formulation designed for dermatological use, combining Fusidic acid (2.0%) and Mometasone (0.1%) in a stable, emulsifiable base. The formulation leverages advanced excipient compatibility to ensure uniform dispersion of active ingredients, enhancing therapeutic consistency. Fusidic acid, a broad-spectrum antifungal and antibacterial agent, is combined with Mometasone, a potent corticosteroid, to address inflammatory and infectious skin conditions. The cream’s pH-neutral base ensures skin compatibility, while its low viscosity facilitates even application. The formulation is optimized for stability under storage conditions, with rigorous testing to maintain potency and integrity. The combination of these active ingredients is carefully balanced to achieve synergistic therapeutic effects without compromising safety or efficacy.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with dedicated facilities for sterile and non-sterile formulations. The production process for Fusac-M Cream employs state-of-the-art homogenization and emulsification techniques to ensure homogeneity and consistency. The facility is equipped with ISO Class 7 cleanrooms for critical steps, ensuring contamination-free processing. All manufacturing activities adhere to current Good Manufacturing Practices (cGMP), with continuous monitoring of temperature, humidity, and pressure to maintain product integrity. Scalability is achieved through modular production lines capable of handling bulk orders while maintaining quality control. Automated quality assurance systems, including real-time data acquisition and process validation, ensure compliance with regulatory standards. The facility also supports customization for varying strengths and packaging formats, ensuring flexibility for global market demands.
Available Strengths and Packaging
Composition: Fusidic acid 2.0% + Mometasone 0.1% cream
Packaging: 10gm
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and private label services tailored to pharmaceutical buyers. Our expertise extends to producing Fusac-M Cream and similar formulations under private label agreements, ensuring full customization of branding, packaging, and specifications. We provide end-to-end solutions, including formulation development, clinical batch production, and packaging, while maintaining compliance with global regulatory frameworks. Our facility is equipped to handle both small-scale trials and large-volume commercial production, making us an ideal partner for pharmaceutical companies seeking scalable, cost-effective manufacturing. We also support third-party manufacturers by offering turnkey solutions, including raw material sourcing, quality assurance, and regulatory documentation, ensuring seamless integration into your supply chain.
Quality Assurance
Our quality control systems are designed to ensure the highest standards of product safety and efficacy. Each batch of Fusac-M Cream undergoes rigorous testing, including pH, viscosity, and active ingredient potency analysis using high-performance liquid chromatography (HPLC). Microbial contamination testing, including sterility checks and endotoxin detection, is conducted to ensure compliance with pharmacopoeial standards. Analytical validation is performed to confirm the accuracy and reproducibility of testing methods, ensuring data reliability. All quality control processes are documented and traceable, with continuous monitoring to detect and mitigate deviations. Our commitment to excellence is reflected in our adherence to pharmacopoeial guidelines, including USP, EP, and BP, ensuring global market acceptance.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards, including ISO 9001 for quality management and ISO 14001 for environmental management. Our manufacturing processes align with regulatory requirements for pharmaceutical products, including documentation, traceability, and batch-specific records. We maintain compliance with global frameworks such as the FDA’s Current Good Manufacturing Practice (CGMP) and the European Medicines Agency (EMA) guidelines, enabling seamless export to markets worldwide. Our quality systems are regularly audited by third-party agencies and regulatory bodies to ensure ongoing adherence to evolving standards. This compliance ensures that Fusac-M Cream meets the stringent requirements of pharmaceutical regulators and healthcare authorities.
Global Supply Capability
Our export capabilities are supported by a robust international distribution network, enabling reliable delivery to over 50 countries. We offer bulk supply options tailored to meet the demands of large-scale distributors and exporters, with logistics solutions designed for efficiency and cost-effectiveness. Our supply chain is optimized for consistency, with inventory management systems ensuring timely fulfillment of orders. We maintain strategic partnerships with freight forwarders and customs brokers to streamline international shipping, reducing lead times and minimizing regulatory delays. Our facility is equipped for large-volume production, supporting both standard and customized packaging requirements. This infrastructure ensures uninterrupted supply chain reliability, even during periods of high demand.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant formulations like Fusac-M Cream. Our commitment to GMP, ISO certification, and regulatory compliance ensures that your products meet global standards. We offer scalable production capabilities, enabling you to meet market demands without compromising quality. Our dedicated customer support team provides end-to-end assistance, from formulation development to export logistics, ensuring a seamless partnership. With a proven track record of reliability and innovation, we are your trusted partner in the pharmaceutical industry.
Bulk Supply Inquiry
We provide bulk supply capabilities for Fusac-M Cream and other pharmaceutical products. For inquiries regarding large-scale orders, please contact us at info@delwishealthcare.com.
FAQs
What is the composition of Fusac-M Cream?
Fusac-M Cream contains Fusidic acid 2.0% and Mometasone 0.1% in a topical cream base, formulated for dermatological use.
Can Fusac-M Cream be manufactured in bulk?
Yes, our facility supports bulk production of Fusac-M Cream, with scalable manufacturing capabilities to meet large-volume demands.
What regulatory standards does Fusac-M Cream comply with?
Fusac-M Cream adheres to GMP, WHO guidelines, ISO 9001, and other global pharmaceutical standards to ensure compliance with international regulations.
Is Fusac-M Cream available in different packaging formats?
Currently, Fusac-M Cream is available in 10gm packaging. Custom packaging options can be discussed for specific market requirements.
What quality control measures are in place for Fusac-M Cream?
Each batch undergoes rigorous testing, including HPLC analysis, microbial testing, and pH/viscosity checks to ensure product integrity.
Can Fusac-M Cream be exported to international markets?
Yes, our export capabilities ensure compliance with global regulatory frameworks, enabling seamless distribution to over 50 countries.
What are the storage conditions for Fusac-M Cream?
Fusac-M Cream should be stored at controlled room temperature (15–30°C), away from moisture and direct sunlight.
Can third-party manufacturers use your facility for production?
Yes, we offer contract manufacturing services, allowing third-party manufacturers to produce Fusac-M Cream under private label agreements.
How long is the shelf life of Fusac-M Cream?
The shelf life of Fusac-M Cream is typically 24 months when stored under recommended conditions.
Can the formulation of Fusac-M Cream be customized?
While the standard formulation is fixed, we offer customization options for excipients, packaging, and strength upon request for specialized market needs.
