Delmont - F is a fixed-dose combination tablet designed for pharmaceutical manufacturers seeking to produce a stable, bioequivalent formulation of Fexofenadine HCL and Montelukast. The formulation integrates two active pharmaceutical ingredients (APIs) with carefully selected excipients to ensure optimal dissolution, bioavailability, and shelf-life stability. Fexofenadine HCL, a second-generation antihistamine, is combined with Montelukast, a leukotriene receptor antagonist, to create a synergistic therapeutic profile. The tablet formulation employs a direct compression method, ensuring uniformity in active ingredient distribution and mechanical strength. The excipients include microcrystalline cellulose as a filler, magnesium stearate as a lubricant, and a disintegrant to facilitate rapid disintegration in aqueous media. The formulation is designed to maintain chemical stability under standard storage conditions (25°C ± 5°C, RH 40-70%), with no significant degradation observed during accelerated stability testing. The manufacturing process prioritizes compatibility between APIs to prevent excipient interference, ensuring compliance with ICH guidelines for solid dosage forms.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The facility includes dedicated tablet compression lines, high-speed coating systems, and advanced packaging equipment to ensure precision in production. Sterile processing capabilities are available for critical dosage forms, supported by a Class 10,000 cleanroom environment for aseptic manufacturing. The production line is scalable to meet bulk supply demands, with a capacity to manufacture up to 50 million tablets per month. Quality systems are integrated throughout the manufacturing process, including real-time monitoring of critical parameters such as tablet hardness, disintegration time, and content uniformity. The facility adheres to strict validation protocols for equipment and processes, ensuring reproducibility and consistency in batch production.
Available Strengths and Packaging
Delmont - F is available in a single strength: Fexofenadine HCL 120mg + Montelukast 10mg. The product is packaged in 10x10 strips, providing a convenient and secure format for distribution. Each strip contains 10 tablets, with 10 strips per blister pack, ensuring efficient storage and transportation. The packaging design is optimized for compliance with global pharmaceutical regulations, including tamper-evident seals and clear labeling for regulatory transparency.
Contract Manufacturing / Third Party Manufacturing
As a trusted pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to meet the needs of global buyers. Our private label manufacturing capabilities allow clients to produce branded or generic versions of Delmont - F under their own trademarks, with full flexibility in packaging, labeling, and regulatory submissions. We support both small-scale pilot batches and large-volume commercial production, ensuring consistency and scalability. Our team of API experts collaborates closely with clients to optimize formulation parameters, ensuring compliance with local and international regulatory requirements. Whether you require a custom dosage form or a turnkey manufacturing solution, our facility is equipped to deliver high-quality, cost-effective production.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Every batch of Delmont - F undergoes comprehensive testing, including High-Performance Liquid Chromatography (HPLC) for API quantification, dissolution testing to ensure bioavailability, and microbial limit testing for contamination control. In-process quality checks are conducted at critical stages of manufacturing, such as granulation, compression, and packaging, to maintain product integrity. The facility is certified under ISO 9001:2015 and adheres to ICH guidelines for analytical method validation. All documentation, including batch records and stability data, is maintained in compliance with FDA and EMA requirements, ensuring traceability and transparency for regulatory submissions.
Regulatory Compliance
Delmont - F is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 standards. The production process meets the requirements of the FDA, EMA, and USP <800> for hazardous drug handling, ensuring safety for both personnel and the environment. Our facility is registered with regulatory authorities in multiple jurisdictions, enabling seamless export to markets in the EU, Asia, and the Americas. Compliance with ISO 11607 for packaging materials and ISO 14644-1 for cleanroom classification further reinforces our commitment to quality. All documentation, including Certificate of Analysis (CoA) and Certificate of Suitability (CoS), is prepared in accordance with global regulatory frameworks, facilitating smooth market entry and compliance audits.
Global Supply Capability
Our global supply chain is designed to deliver bulk supply capabilities to pharmaceutical buyers worldwide. With a robust international distribution network, we export to over 50 countries, supported by logistics partners specializing in pharmaceutical freight. The facility is equipped to handle large-scale bulk orders, with storage capacity for up to 10 million tablets. Our supply chain reliability is ensured through real-time tracking systems, inventory management protocols, and contingency planning for disruptions. We prioritize compliance with international shipping regulations, including HS code classification and documentation for customs clearance. Whether you require short-term supply or long-term contracts, our export capabilities are tailored to meet the demands of global pharmaceutical distributors and exporters.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select our facility for its combination of technical expertise, regulatory compliance, and operational efficiency. Our ability to deliver bulk supply at competitive pricing, coupled with rigorous quality assurance, positions us as a preferred partner in the global pharmaceutical market. The facility’s compliance with GMP, WHO, and ISO standards ensures seamless regulatory approvals, while our scalable manufacturing capabilities accommodate diverse production needs. Additionally, our dedicated customer support team provides end-to-end assistance, from formulation development to export logistics, ensuring a seamless partnership for buyers seeking reliable, high-quality pharmaceutical solutions.
Bulk Supply Inquiry
We offer bulk supply capabilities for Delmont - F, with flexible order quantities to meet the needs of pharmaceutical buyers. For inquiries regarding bulk procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What certifications does your facility hold for manufacturing Delmont - F?
Our facility is certified under GMP, ISO 9001:2015, and WHO guidelines, ensuring compliance with global pharmaceutical standards.
Can you produce Delmont - F in different packaging formats?
Yes, we offer customization options for packaging, including blister strips, bottles, and cartons, to meet specific market requirements.
What is the minimum order quantity for bulk supply?
We accommodate both small-scale and large-volume orders, with minimum quantities tailored to individual buyer needs.
How do you ensure the stability of Delmont - F during storage?
The formulation is tested for stability under accelerated conditions, and packaging is designed to maintain product integrity within recommended storage parameters.
Are you compliant with FDA and EMA regulations?
Yes, our manufacturing process and documentation meet the requirements of FDA, EMA, and other global regulatory authorities.
Can you provide documentation for regulatory submissions?
We supply complete documentation, including CoA, CoS, and stability data, to support regulatory submissions and market approvals.
What is your lead time for production and delivery?
Lead times vary based on order size and complexity, but we prioritize timely delivery to meet client deadlines.
Do you offer private label manufacturing for Delmont - F?
Yes, we provide private label manufacturing services, allowing clients to brand the product under their own trademarks.
How do you handle quality control during the manufacturing process?
We conduct in-process testing, batch validation, and final product analysis to ensure compliance with quality standards.
Can you supply Delmont - F for export to specific regions?
Our global distribution network supports exports to over 50 countries, with compliance measures tailored to regional regulatory requirements.
