Dotrawis - MF is a dual-active pharmaceutical formulation combining Drotaverine (80mg) and Mefenamic Acid (250mg) in a compressed tablet form. The formulation is engineered to ensure optimal dissolution, bioavailability, and stability of both active ingredients. Drotaverine, a synthetic antispasmodic agent, is combined with Mefenamic Acid, a non-steroidal anti-inflammatory drug (NSAID), to create a synergistic therapeutic profile. The tablet’s excipients are selected to maintain chemical compatibility, ensure uniformity in dosage, and enhance mechanical strength for robust packaging. The formulation adheres to pharmaceutical principles of solid dosage form design, including controlled disintegration rates and moisture resistance, ensuring consistent performance across storage and transportation conditions.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities equipped for high-volume tablet manufacturing. The production line includes advanced tablet compression machines, coating systems, and automated blister packaging units, enabling precise control over dosage uniformity and tablet integrity. Sterile processing capabilities are maintained through ISO-certified cleanrooms, ensuring contamination-free environments for sensitive formulations. All manufacturing processes comply with current Good Manufacturing Practices (cGMP), with rigorous validation protocols for equipment, materials, and procedures. The facility supports scalable production, allowing seamless transitions from small batches to large-scale commercial runs while maintaining quality consistency. Quality systems are integrated throughout the manufacturing workflow, including real-time monitoring, data integrity management, and traceability for full regulatory compliance.
Available Strengths and Packaging
Composition: Drotaverine 80mg + Mefenamic Acid 250mg Tab
Packaging: 10x10 Blister
Dotrawis - MF is available in a single strength of 80mg Drotaverine combined with 250mg Mefenamic Acid, packaged in 10x10 blister packs. This packaging format ensures secure storage, tamper-evidence, and efficient distribution, catering to both retail and institutional pharmaceutical needs.
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 finished products under a client’s brand, as well as contract manufacturing for OEM/ODM requirements. We support customization of dosage forms, packaging, and labeling, ensuring alignment with global market standards. Our team collaborates closely with clients to design scalable production strategies, manage regulatory documentation, and ensure compliance with international quality frameworks. This flexibility positions us as a reliable partner for pharmaceutical companies seeking to expand their product portfolios or enter new markets.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation, batch-specific testing, and adherence to pharmaceutical quality standards. Every batch of Dotrawis - MF undergoes comprehensive quality control checks, including physicochemical testing (e.g., dissolution, disintegration, and content uniformity), microbial limit testing, and heavy metal analysis. Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry are employed to validate active ingredient potency and purity. All quality control data is documented in accordance with cGMP and ISO 9001 standards, ensuring transparency and traceability. Our commitment to excellence is further reinforced by third-party audits and certification from recognized quality bodies, guaranteeing product reliability for global distribution.
Regulatory Compliance
Dotrawis - MF is manufactured in full compliance with international regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001 quality management standards. Our facility is certified under ISO 17025 for testing laboratories and maintains compliance with the FDA’s Current Good Manufacturing Practice (CGMP) regulations for pharmaceuticals. We adhere to regional regulatory requirements, including the European Medicines Agency (EMA) guidelines, the U.S. FDA’s 21 CFR Part 211, and the Indian Pharmacopoeia (IP) standards. Our documentation processes ensure full traceability, batch-specific records, and regulatory-ready submissions, enabling seamless market access across global jurisdictions.
Global Supply Capability
We provide robust global supply capabilities, with a well-established international distribution network spanning key markets in Asia, Africa, Latin America, and Europe. Our bulk supply capacity is supported by a scalable production infrastructure, enabling consistent delivery of high-quality products in large volumes. The supply chain is fortified with logistics partnerships, real-time tracking systems, and compliance with international shipping regulations, ensuring timely and secure delivery. Our export capabilities are further enhanced by adherence to pharma-specific import/export protocols, including documentation for customs clearance and compliance with destination country regulations. This ensures uninterrupted supply chain reliability, even during high-demand periods or geopolitical uncertainties.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our unwavering commitment to quality, regulatory compliance, and scalable production. Our expertise in manufacturing complex combination products like Dotrawis - MF ensures that clients receive reliable, cost-effective solutions tailored to their market needs. With a focus on innovation, compliance, and customer-centric service, we deliver end-to-end solutions that meet the demands of the global pharmaceutical industry. Our ability to navigate regulatory landscapes, support customized packaging, and ensure consistent supply makes us a strategic partner for businesses seeking to expand their footprint in the pharmaceutical sector.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking reliable, high-quality products at scale.
FAQs
What manufacturing standards does Dotrawis - MF comply with?
Dotrawis - MF is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global pharmaceutical quality benchmarks.
Can Dotrawis - MF be produced in different packaging formats?
While the standard packaging is 10x10 blister, we offer customization options for alternative packaging formats upon client request.
What is the shelf life of Dotrawis - MF?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Does your facility support sterile manufacturing processes?
Yes, our facility is equipped with ISO Class 7 cleanrooms and sterile processing capabilities for sensitive pharmaceutical products.
Can you provide documentation for regulatory submissions?
We offer complete regulatory documentation, including batch records, analytical reports, and compliance certificates for global market access.
What is your minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client requirements, with scalable production to meet large-scale demands.
How do you ensure quality consistency across batches?
Quality consistency is maintained through rigorous in-process controls, batch-specific testing, and continuous validation of manufacturing parameters.
Can you support private label manufacturing for Dotrawis - MF?
Yes, we provide private label manufacturing services, allowing clients to brand the product under their own label while maintaining quality standards.
What is your export compliance framework?
Our export processes comply with international regulations, including customs documentation, pharma-specific import rules, and destination country requirements.
How do you handle supply chain disruptions?
We implement contingency planning, including diversified supplier networks and buffer stock management, to ensure uninterrupted supply chain reliability.
