Delspa MF is a dual-action pharmaceutical formulation combining Dicyclomine Hydrochloride (10mg) and Mefenamic Acid (250mg) in a single tablet. The active ingredients are carefully integrated into a stable, uniform matrix to ensure consistent bioavailability and therapeutic efficacy. Dicyclomine Hydrochloride, a antispasmodic agent, is formulated to act on smooth muscle receptors, while Mefenamic Acid, a non-steroidal anti-inflammatory drug (NSAID), provides analgesic and anti-inflammatory effects. The tablet’s formulation includes excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, which enhance tablet integrity, flow properties, and disintegration. The manufacturing process ensures optimal dissolution profiles, with both active ingredients demonstrating rapid release in simulated gastric and intestinal fluids. The formulation is designed for stability under standard storage conditions (15–30°C, 45% RH) and maintains chemical compatibility to prevent degradation or interaction between components.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is built on state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line for Delspa MF includes high-speed tablet presses, advanced coating systems, and automated packaging equipment, ensuring precision and scalability. Sterile processing capabilities are maintained through ISO Class 7 cleanroom environments, with dedicated lines for sensitive formulations. The facility adheres to rigorous quality control protocols, including in-process testing for particle size, moisture content, and tablet hardness. Production scalability is supported by modular manufacturing units capable of handling bulk orders while maintaining consistency in dosage form quality. Comprehensive quality systems, including traceability and documentation, ensure full compliance with regulatory requirements and support seamless supply chain integration.
Available Strengths and Packaging
Composition: Dicyclomine Hydrochloride 10mg + Mefenamic Acid 250mg Tab
Packaging: 20x10 Blister
Delspa MF is available in a single strength formulation, optimized for therapeutic efficacy and patient compliance. The 20x10 blister packaging ensures secure, tamper-evident storage and distribution, with each blister containing 10 tablets for easy dispensing. This packaging format is ideal for retail and institutional use, offering protection against moisture, light, and contamination while maintaining product stability.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer and supplier, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce branded formulations under our facility’s cGMP-compliant infrastructure. We support contract manufacturing for both generic and branded products, with flexibility in dosage forms, packaging, and regulatory submissions. Our team collaborates with global clients to meet specific requirements, including API sourcing, formulation development, and regulatory compliance. Whether you need bulk production or niche formulations, we provide end-to-end solutions, ensuring adherence to international standards and supply chain efficiency.
Quality Assurance
Our quality assurance systems are designed to meet the highest pharmaceutical standards, ensuring consistency, safety, and efficacy in every batch of Delspa MF. Rigorous batch testing includes analytical validation through high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to confirm drug release profiles, and impurity analysis to ensure compliance with ICH guidelines. In-process controls monitor critical parameters such as tablet weight, disintegration time, and hardness, while final product testing verifies potency, uniformity, and stability. All quality data is documented and traceable, supporting regulatory submissions and audit readiness. Our commitment to quality extends to raw material sourcing, with third-party testing for purity and compliance with pharmacopeial standards.
Regulatory Compliance
Delspa MF is manufactured in full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our facility is certified by regulatory authorities in multiple jurisdictions, ensuring adherence to international pharmacopeial standards such as USP, EP, and BP. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and analytical reports. Compliance with the International Council for Harmonisation (ICH) guidelines ensures consistency in quality, safety, and efficacy across markets. Our regulatory expertise supports clients in navigating complex approval processes, from pre-market submissions to post-market surveillance.
Global Supply Capability
As a trusted exporter and bulk supplier, we provide reliable global supply chain solutions for Delspa MF. Our international distribution network spans key markets, supported by strategic logistics partnerships and compliance with export regulations. Bulk supply capacity is optimized through scalable production lines, enabling large-scale orders without compromising quality. We ensure supply chain reliability through real-time tracking, inventory management, and contingency planning. Our facilities are equipped to handle temperature-sensitive and moisture-sensitive products, with controlled storage solutions for long-term stability. Whether you require regional distribution or global exports, we deliver consistent, timely supply with adherence to international shipping standards.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in high-quality pharmaceutical production, regulatory compliance, and global supply capabilities. As a manufacturer and supplier, we offer competitive pricing, rapid turnaround times, and tailored solutions to meet diverse market needs. Our commitment to innovation and quality ensures that products like Delspa MF meet stringent standards while supporting sustainable business growth. With a proven track record in the industry, we provide end-to-end support, from formulation development to global distribution, ensuring seamless integration into your supply chain.
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 regulatory guidance.
FAQs
What manufacturing standards does Delspa MF comply with?
Delspa MF is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global pharmaceutical quality requirements.
Can Delspa MF be produced in different packaging formats?
Yes, we offer flexible packaging options, including blister, strip, and bulk formats, tailored to meet specific market and regulatory requirements.
What is the shelf life of Delspa MF?
The shelf life of Delspa MF is typically 24 months when stored under recommended conditions (15–30°C, 45% RH).
Does your facility support private label manufacturing?
Yes, we provide private label manufacturing services, enabling clients to brand and distribute products under their own trademarks.
How do you ensure quality consistency in bulk supply?
We maintain rigorous quality control systems, including batch testing, analytical validation, and real-time monitoring to ensure consistent product quality.
Can you support export to specific regions?
Yes, our global distribution network supports exports to all major markets, with compliance measures tailored to regional regulations.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be customized based on client requirements and production capacity.
How do you handle regulatory submissions for international markets?
Our team provides comprehensive regulatory support, including documentation, stability data, and compliance reports for global market entry.
Are there options for customized formulation?
Yes, we offer formulation development services to tailor products to specific therapeutic needs and market demands.
What is your response time for bulk supply inquiries?
We prioritize timely responses and provide dedicated support to address bulk supply inquiries within 24 hours of contact.
