Tenamic - MF is a fixed-dose combination tablet formulated with Tranexamic Acid (500mg) and Mefenamic Acid (250mg), designed for pharmaceutical manufacturers requiring a stable, scalable, and compliant dosage form. The formulation leverages advanced excipient compatibility testing to ensure optimal dissolution profiles and tablet integrity. Tranexamic Acid, a synthetic amino acid derivative, is formulated with a controlled-release mechanism to enhance bioavailability, while Mefenamic Acid, a non-steroidal anti-inflammatory drug (NSAID), is incorporated to ensure rapid onset of action. The tablet matrix is engineered for uniform content distribution, with excipients selected for their chemical stability and compatibility with both active pharmaceutical ingredients (APIs). The formulation process includes wet granulation and direct compression techniques, ensuring consistent tablet hardness, disintegration time, and weight variation. The final product meets stringent pharmaceutical requirements for solubility, pH compatibility, and long-term stability under accelerated storage conditions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities to produce Tenamic - MF at scale, adhering to global Good Manufacturing Practice (GMP) standards. The facility includes high-speed tablet presses, automated packaging lines, and advanced quality control laboratories to ensure precision in formulation and processing. Sterile processing capabilities are available for critical components, with dedicated cleanrooms maintaining ISO 7 and ISO 8 classifications. Production scalability is achieved through modular manufacturing systems, enabling seamless transitions from small batch trials to bulk production. Quality systems are integrated throughout the manufacturing process, with real-time monitoring of critical parameters such as temperature, humidity, and particle size. The facility is compliant with international GMP guidelines, ensuring traceability, documentation, and adherence to regulatory requirements for pharmaceutical manufacturers.
Available Strengths and Packaging
Composition: Tranexamic Acid 500mg + Mefenamic Acid 250mg Tab.
Packaging: 10x10 Blister
Tenamic - MF is available in a single strength formulation, with each tablet containing 500mg of Tranexamic Acid and 250mg of Mefenamic Acid. The 10x10 blister packaging ensures tamper-evident storage, protection from moisture, and convenient distribution for pharmaceutical suppliers and exporters. The packaging design is optimized for bulk supply, with compliance to international pharmaceutical packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a leading pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party production services for Tenamic - MF, tailored to meet the needs of global buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own specifications, with full flexibility in formulation, packaging, and labeling. We support both small-scale trials and large-volume production, ensuring consistency and compliance with regulatory frameworks. Our team of pharmacists and engineers works closely with clients to optimize formulation parameters, ensuring adherence to quality standards while maintaining cost-efficiency. For pharmaceutical exporters and distributors, we provide end-to-end solutions, including API sourcing, formulation development, and packaging customization.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of purity, potency, and consistency in Tenamic - MF. Every batch undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to confirm bioavailability, and microbial limit checks for sterility. In-process controls are implemented at critical stages of manufacturing, with real-time data monitoring to prevent deviations. Analytical validation protocols are aligned with International Council for Harmonisation (ICH) guidelines, ensuring method reliability and reproducibility. All quality control measures are documented to meet the requirements of pharmaceutical manufacturers, suppliers, and regulatory authorities.
Regulatory Compliance
Tenamic - MF is manufactured in full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO 9001:2015 quality management standards. Our facility is certified by regulatory bodies such as the FDA, EMA, and PIC/S, ensuring adherence to international pharmaceutical manufacturing practices. Documentation for regulatory submissions, including batch records, stability data, and analytical reports, is maintained to support export compliance. We also ensure compliance with the United Nations’ Globally Harmonized System (GHS) for chemical safety labeling. For pharmaceutical exporters, we provide all necessary regulatory documentation to facilitate smooth market entry in target regions.
Global Supply Capability
Our global supply chain is designed to meet the demands of pharmaceutical manufacturers, exporters, and distributors worldwide. With a robust international distribution network, we ensure timely delivery of bulk supplies to over 50 countries. Our logistics partners specialize in temperature-controlled shipping and customs compliance, enabling seamless export of Tenamic - MF to regions with strict regulatory requirements. Bulk supply capacity is supported by scalable production capabilities, with inventory management systems to guarantee uninterrupted supply chains. We prioritize supply chain reliability through redundant manufacturing hubs and strategic regional warehousing, ensuring minimal lead times for pharmaceutical buyers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our commitment to quality, compliance, and scalability. Our expertise in GMP-compliant manufacturing ensures that Tenamic - MF meets the highest standards for bulk supply and global distribution. As a trusted supplier, we offer end-to-end solutions, from formulation development to packaging and export logistics, reducing the complexity for buyers. Our ability to adapt to diverse regulatory environments and market demands makes us a reliable partner for pharmaceutical manufacturers seeking to expand their product portfolios.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our dedicated sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Tenamic - MF comply with?
Tenamic - MF is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 standards, ensuring quality and safety for global markets.
Can Tenamic - MF be produced in different packaging formats?
Yes, we offer flexible packaging options, including 10x10 blister packs, to meet the specific requirements of pharmaceutical manufacturers and exporters.
What is the minimum order quantity for bulk supply?
We accommodate both small-scale trials and large-volume orders, with minimum order quantities tailored to the needs of pharmaceutical buyers.
Does your facility support sterile manufacturing processes?
Yes, our facility is equipped with sterile processing capabilities, including ISO 7 and ISO 8 cleanrooms, for critical pharmaceutical production.
How do you ensure the stability of Tenamic - MF under storage conditions?
We conduct accelerated stability testing to confirm the product’s shelf life and compliance with international storage guidelines.
Can you provide documentation for regulatory submissions?
Yes, we supply comprehensive documentation, including batch records, analytical reports, and stability data, to support regulatory compliance.
What is your export compliance process for Tenamic - MF?
Our export process includes adherence to GHS labeling, customs documentation, and compliance with destination-specific regulatory requirements.
How do you handle quality control during production?
We implement real-time monitoring, in-process controls, and rigorous batch testing to ensure consistency and compliance with pharmaceutical standards.
Can you customize the formulation for private label manufacturing?
Yes, our private label manufacturing services allow customization of formulation, packaging, and labeling to meet client specifications.
What is your lead time for bulk orders?
Lead times vary based on order size and production capacity, but we prioritize timely delivery to ensure uninterrupted supply for pharmaceutical buyers.
