Tefin - 250 is a robust, high-purity terbinafine formulation designed for pharmaceutical manufacturers requiring consistent quality and stability. The active ingredient, terbinafine hydrochloride (250mg), is combined with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal tablet integrity, disintegration, and dissolution rates. The formulation is engineered to meet stringent pharmaceutical specifications, including uniform content, hardness, and weight variation, ensuring reproducibility in large-scale production. The tablet’s design facilitates efficient processing, with a balanced ratio of binder, lubricant, and disintegrant to maintain mechanical strength while enabling rapid disintegration in aqueous environments. The product’s formulation adheres to global pharmacopeial standards, ensuring compatibility with advanced manufacturing technologies and regulatory requirements.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is built to deliver high-quality, scalable production of Tefin - 250. The facility is equipped with state-of-the-art tablet compression machines, high-speed coating systems, and automated blister packaging lines, ensuring precision and efficiency. Sterile processing capabilities are available for critical applications, with dedicated cleanrooms meeting ISO 7 and ISO 8 standards. All manufacturing processes comply with current Good Manufacturing Practices (cGMP), with rigorous documentation and traceability systems in place. The facility supports production scalability, enabling seamless transitions from pilot batches to bulk supply without compromising quality. Advanced quality systems, including real-time monitoring and process validation, ensure consistent product performance. Additionally, the site is certified for pharmaceutical-grade raw material handling, storage, and packaging, with a focus on minimizing contamination risks and maintaining product integrity.
Available Strengths and Packaging
Composition: Terbinafine 250mg Tab.
Packaging: 10x7 Blister
Tefin - 250 is available in a single strength of 250mg, formulated to meet the demands of antifungal therapy. The product is packaged in a 10x7 blister format, providing secure, tamper-evident storage and easy dispensing. This packaging design ensures product stability during transportation and shelf life, while also supporting efficient inventory management for pharmaceutical distributors.
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 branded formulations under our own quality control systems, and contract manufacturing for existing brands, ensuring compliance with regulatory and quality standards. We support customization of dosage forms, excipient blends, and packaging formats to meet specific market requirements. Our team provides end-to-end solutions, from formulation development to finished product delivery, with flexibility to adapt to evolving industry needs. This service is ideal for exporters, distributors, and manufacturers seeking to expand their product portfolios while maintaining compliance and quality assurance.
Quality Assurance
Our quality assurance framework is designed to deliver pharmaceutical-grade products with zero tolerance for deviations. Every batch of Tefin - 250 undergoes rigorous testing, including in-process controls, finished product analysis, and stability studies. Key analytical methods such as high-performance liquid chromatography (HPLC), dissolution testing, and microbial limit testing are employed to validate purity, potency, and uniformity. Batch-specific documentation, including certificates of analysis (COA) and batch records, ensures transparency and traceability. We adhere to pharmacopeial standards (USP, EP, BP) and implement continuous improvement programs to refine manufacturing processes. Additionally, our quality control systems are aligned with ISO 9001 certification, ensuring consistent performance and customer satisfaction.
Regulatory Compliance
Tefin - 250 is manufactured in full compliance with global regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and International Organization for Standardization (ISO) standards. Our facility is certified under ISO 9001 and ISO 14001, reflecting our commitment to quality and environmental responsibility. We ensure adherence to regulatory requirements for export, including the U.S. FDA, EU GMP, and ICH guidelines, enabling seamless market access. All documentation, from raw material sourcing to finished product release, is prepared to meet the specifications of international regulatory bodies. This compliance ensures that Tefin - 250 meets the highest standards of safety, efficacy, and quality for global distribution.
Global Supply Capability
We provide reliable global supply capabilities, with a well-established international distribution network and bulk supply capacity to meet large-scale demand. Our export logistics infrastructure supports seamless delivery to over 50 countries, leveraging partnerships with trusted freight forwarders and customs brokers. Bulk supply options are available for pharmaceutical buyers requiring high-volume procurement, with flexible order sizes and delivery timelines. Our supply chain is designed for resilience, with redundant inventory systems and real-time tracking to ensure on-time shipments. We prioritize supply chain reliability through rigorous vendor assessments, compliance audits, and contingency planning, ensuring uninterrupted availability of Tefin - 250 for global markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant products like Tefin - 250. Our competitive advantages include adherence to global regulatory standards, scalable manufacturing capabilities, and a commitment to excellence in quality assurance. As a trusted manufacturer and supplier, we offer tailored solutions to meet the unique needs of our clients, from formulation development to global distribution. Our ISO-certified facility, combined with a dedicated customer support team, ensures that partners receive end-to-end support, enabling them to focus on market expansion and business growth.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with procurement, customization, and logistics planning to meet your pharmaceutical needs.
FAQs
What manufacturing standards does Tefin - 250 comply with?
Tefin - 250 is manufactured in compliance with cGMP, WHO guidelines, ISO 9001, and international regulatory frameworks, ensuring adherence to global quality standards.
Can Tefin - 250 be produced in different packaging formats?
While Tefin - 250 is currently available in 10x7 blister packaging, we offer customization options for alternative packaging formats upon request.
What excipients are used in the formulation of Tefin - 250?
The formulation includes microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure tablet integrity and disintegration.
Is Tefin - 250 suitable for export to regulated markets?
Yes, Tefin - 250 meets the regulatory requirements of the FDA, EU GMP, and ICH, making it suitable for export to global markets.
What quality control measures are in place for Tefin - 250?
Each batch undergoes HPLC, dissolution testing, microbial limit testing, and stability studies to ensure consistency and purity.
Can Tefin - 250 be produced in bulk quantities?
Yes, our facility supports scalable production, enabling bulk supply to meet large-volume procurement needs.
What is the shelf life of Tefin - 250?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability studies.
How does your company ensure supply chain reliability?
We maintain redundant inventory systems, real-time tracking, and partnerships with logistics providers to ensure on-time delivery and supply continuity.
Can I request a sample of Tefin - 250 for testing?
Yes, we provide samples upon request for quality testing and validation purposes.
What is the minimum order quantity for Tefin - 250?
Minimum order quantities are flexible and can be customized based on the buyer’s requirements and production scale.
