Gentin - M is a dual-action pharmaceutical formulation combining Gabapentin (300mg) and Methylcobalamin (500mcg) in a single tablet. The formulation is engineered to ensure optimal stability, uniformity, and bioavailability of both active ingredients. Gabapentin, a neuroactive compound, is formulated with a controlled-release mechanism to ensure consistent therapeutic levels, while Methylcobalamin, a water-soluble vitamin B12 derivative, is incorporated to enhance solubility and absorption. The tablet matrix is designed to withstand standard storage conditions, with excipients selected for compatibility, disintegration efficiency, and compression strength. The formulation process adheres to pharmaceutical best practices, ensuring minimal degradation of active ingredients during manufacturing. The combination of these two compounds in a single dosage form simplifies administration and improves compliance, making it suitable for bulk supply and global distribution.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and designed to produce high-quality pharmaceutical products. The production line for Gentin - M includes advanced tablet compression machines, coating systems, and packaging equipment, ensuring precision in dosage form consistency. Sterile processing capabilities are maintained through dedicated cleanrooms and controlled environmental conditions, minimizing contamination risks. The facility adheres to rigorous quality systems, including ISO 9001 certification, to ensure process validation, traceability, and continuous improvement. Production scalability is achieved through modular manufacturing units, allowing for flexible output to meet varying demand. All processes are monitored with real-time data collection and analytics to ensure compliance with regulatory standards and product integrity.
Available Strengths and Packaging
Composition: Gabapentin 300mg + Methylcobalamin 500mcg Tab
Packaging: 10x10 Alu Alu
Gentin - M is available in a single strength formulation, combining 300mg of Gabapentin with 500mcg of Methylcobalamin in a tablet form. The 10x10 Alu Alu packaging consists of 10 blister packs, each containing 10 tablets, sealed in aluminum foil to ensure moisture resistance, light protection, and extended shelf life. This packaging format is ideal for bulk supply, retail, and distribution channels requiring secure, tamper-evident packaging. The design ensures product stability under standard storage conditions, making it suitable for global markets.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers. Our facility is equipped to produce custom formulations, including Gentin - M, under private label agreements, ensuring brand-specific packaging, labeling, and compliance with regional regulatory requirements. We support both small-scale and large-volume production runs, with the ability to adapt to diverse specifications and quality standards. Our team collaborates closely with clients to ensure seamless integration of manufacturing processes, from raw material sourcing to final packaging. This flexibility makes us a preferred partner for exporters, distributors, and contract manufacturers seeking reliable, compliant production solutions.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Each batch of Gentin - M undergoes in-process testing for critical parameters such as weight variation, disintegration time, and active ingredient content. Final product testing includes High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry to confirm potency and purity. We maintain detailed records of all quality control data, ensuring traceability and compliance with pharmacopeial standards. Our quality systems are validated to meet ISO 17025 requirements, with continuous improvement initiatives to enhance process efficiency and product consistency.
Regulatory Compliance
Gentin - M is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international regulatory frameworks. Our facility holds certifications for ISO 9001 (quality management), ISO 14001 (environmental management), and ISO 45001 (occupational health and safety), ensuring adherence to global benchmarks. We maintain compliance with FDA, EMA, and other regional regulatory authorities, enabling seamless export to markets worldwide. All documentation, including batch records, stability data, and certificates of analysis, is prepared to meet the requirements of regulatory bodies and pharmaceutical buyers.
Global Supply Capability
We provide robust global supply capabilities, including bulk export, international distribution, and reliable supply chain logistics. Our network spans key markets, supported by partnerships with logistics providers and customs clearance experts to ensure timely and compliant delivery. Bulk supply capacity is optimized through scalable production and efficient inventory management, enabling consistent supply even during high-demand periods. Our supply chain is designed for resilience, with contingency planning to mitigate disruptions and ensure uninterrupted service. This infrastructure supports pharmaceutical buyers seeking dependable, high-quality products for domestic and international markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our commitment to quality, compliance, and scalability. Our expertise in producing complex formulations like Gentin - M ensures reliable, consistent supply chains. We offer competitive pricing without compromising on regulatory adherence, making us a strategic partner for global operations. Our team provides end-to-end support, from manufacturing to export logistics, ensuring seamless integration into clients’ business processes. With a focus on innovation, sustainability, and customer satisfaction, we deliver solutions that meet the evolving needs of the pharmaceutical industry.
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 supply chain coordination.
FAQs
What manufacturing standards does Gentin - M adhere to?
Gentin - M is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical quality standards.
Can Gentin - M be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization for alternative formats upon request, subject to regulatory approval.
What is the shelf life of Gentin - M?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Is bulk supply available for Gentin - M?
Yes, we provide bulk supply options tailored to meet the needs of distributors and exporters.
What quality control measures are in place for Gentin - M?
Each batch undergoes rigorous testing, including HPLC and UV analysis, to ensure potency, purity, and compliance with pharmacopeial standards.
Can Gentin - M be produced under private label agreements?
Yes, we support private label manufacturing, allowing clients to brand the product according to their specifications.
What regulatory certifications does your facility hold?
Our facility is certified under ISO 9001, ISO 14001, and ISO 45001, with compliance to FDA, EMA, and WHO guidelines.
How do you ensure supply chain reliability for international exports?
We maintain a robust logistics network and partnerships with customs experts to ensure timely, compliant delivery to global markets.
Can you accommodate urgent or customized production requests?
Yes, our flexible manufacturing capabilities allow for expedited production and customization to meet specific client needs.
How can I contact your team for bulk supply inquiries?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com**. Our team is available to assist with order placement and supply chain coordination.
