Footnut Cream is a multifunctional topical formulation engineered for pharmaceutical applications, combining humectants, emollients, and surfactants to achieve optimal skin conditioning. The formulation includes urea (10.0% w/w), a key humectant and keratolytic agent, which enhances moisture retention and exfoliates hyperkeratinized skin. Liquid paraffin (9.0% w/w) and shea butter (5.0% w/w) act as emollients, forming a protective barrier to prevent transepidermal water loss. Cetostearyl alcohol (6.33% w/w) and stearyl alcohol (3.0% w/w) provide emulsifying and thickening properties, ensuring a stable emulsion. Glycerin (5.0% w/w) and propylene glycol (5.0% w/w) further enhance hydration, while dimethicone (1.0% w/w) imparts a smooth, non-greasy texture. Glyceryl monostearate (1.0% w/w) and sodium lauryl sulfate (1.0% w/w) contribute to emulsion stability and foaming properties. Preservatives such as methylparaben (0.1% w/w) and propylparaben (0.05% w/w) ensure microbial stability, and allantoin (0.2% w/w) provides mild soothing effects. The formulation’s balanced composition ensures compatibility with pharmaceutical-grade excipients, making it suitable for dermatological and topical applications.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet pharmaceutical-grade production standards, with dedicated facilities for sterile and non-sterile formulation processing. The facility adheres to current Good Manufacturing Practices (cGMP) and is equipped with state-of-the-art equipment for precise blending, homogenization, and packaging. Sterile processing capabilities are available for critical applications, supported by ISO Class 7 cleanroom environments. Production scalability is ensured through modular manufacturing lines capable of handling bulk orders for 100gm units. Quality systems include real-time monitoring, automated process controls, and documentation compliance with regulatory frameworks. The facility maintains rigorous validation protocols for equipment, materials, and processes to ensure consistency and reproducibility in every batch.
Available Strengths and Packaging
Footnut Cream is formulated with a fixed strength of 10% urea, ensuring uniform efficacy and stability. The product is available in 100gm packaging, optimized for pharmaceutical distribution and bulk supply. The formulation’s composition is precisely calibrated to meet stability and performance requirements, with all excipients sourced from pharmaceutical-grade suppliers.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce under a client’s brand name, and contract manufacturing for customized formulations. We support full-service solutions, from raw material sourcing to final packaging, ensuring compliance with global regulatory standards. Our team collaborates with clients to optimize formulations, streamline production, and meet specific quality and packaging requirements. For third-party manufacturing, we provide end-to-end support, including regulatory documentation, stability testing, and compliance audits.
Quality Assurance
Our quality assurance framework ensures rigorous control over every stage of production. Each batch undergoes comprehensive testing, including microbial limit tests, pH measurement, and preservative efficacy studies. Analytical validation is performed using HPLC, UV-Vis spectroscopy, and titration methods to confirm active ingredient content and excipient compatibility. Quality control systems are aligned with ICH and USP guidelines, with documented batch records and traceability protocols. Regular internal audits and third-party inspections ensure adherence to pharmaceutical standards. All raw materials and finished products are tested for purity, potency, and stability, guaranteeing consistent quality for bulk supply.
Regulatory Compliance
We comply with global regulatory frameworks, including GMP, WHO guidelines, and ISO 9001:2015 standards. Our facility is certified for pharmaceutical manufacturing and adheres to FDA, EMA, and PIC/S requirements for quality assurance. Products are manufactured in accordance with WHO prequalification standards, ensuring suitability for international markets. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and deviation reports. Compliance with ISO 14001 for environmental management and ISO 45001 for occupational health and safety further underscores our commitment to sustainable and safe manufacturing practices.
Global Supply Capability
Our global supply chain enables reliable export and distribution to over 50 countries. We maintain strategic partnerships with logistics providers to ensure timely delivery of bulk orders, with a focus on supply chain resilience and compliance. The 100gm packaging is optimized for efficient storage and transportation, supporting both regional and international distribution. Our facility is equipped to handle large-scale production, with capacity for continuous bulk supply to meet demand. We prioritize supply chain transparency, offering real-time tracking and inventory management systems to ensure order fulfillment and regulatory compliance.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in formulation development, regulatory compliance, and scalable production. Our commitment to quality, combined with flexible manufacturing solutions, ensures seamless integration into global supply chains. We provide tailored support for bulk supply, with a focus on cost-efficiency, compliance, and product consistency. Our team’s pharmaceutical expertise and adherence to international standards make us a reliable partner for businesses seeking high-quality, compliant products.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customization, pricing, and order fulfillment.
FAQs
What is the role of urea in Footnut Cream?
Urea (10.0% w/w) acts as a humectant and keratolytic agent, enhancing moisture retention and exfoliating dry, hyperkeratinized skin.
Is Footnut Cream suitable for pharmaceutical-grade manufacturing?
Yes, the formulation is designed for pharmaceutical applications, with excipients sourced from certified suppliers and processed under cGMP standards.
Can Footnut Cream be packaged in quantities other than 100gm?
The current formulation is optimized for 100gm packaging. Custom packaging options may be available upon consultation with our team.
What preservatives are used in Footnut Cream?
Methylparaben (0.1% w/w) and propylparaben (0.05% w/w) are used to ensure microbial stability, meeting pharmaceutical-grade preservative standards.
Does Footnut Cream require sterile processing?
Sterile processing is optional and available for critical applications. The formulation’s stability allows for non-sterile manufacturing under cGMP conditions.
What regulatory standards does Footnut Cream comply with?
The product adheres to GMP, WHO guidelines, ISO 9001, and regional regulatory frameworks, including FDA and EMA requirements.
Can Footnut Cream be exported internationally?
Yes, our global supply chain and compliance with international standards enable seamless export to over 50 countries.
What is the shelf life of Footnut Cream?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data available upon request.
How does your quality assurance process work?
Each batch undergoes microbial testing, pH analysis, preservative efficacy studies, and analytical validation to ensure compliance with pharmaceutical standards.
Can you accommodate custom formulations or packaging?
Yes, we offer private label manufacturing and contract production services, with flexibility to adjust formulations and packaging to meet specific requirements.
