Preplin M is a meticulously formulated fixed-dose combination tablet designed to deliver therapeutic synergy through its active ingredients: Pregabalin (75mg), Nortriptyline (10mg), and Methylcobalamin (1500mcg). The formulation leverages advanced pharmaceutical engineering to ensure optimal dissolution, stability, and bioavailability. Pregabalin, a gabapentinoid, is incorporated as a fine, crystalline powder to enhance uniformity in compression. Nortriptyline, a tricyclic antidepressant, is micronized to improve flow properties during tableting. Methylcobalamin, the active form of vitamin B12, is added in a stable, disintegratable form to ensure rapid release. The tablet matrix is formulated using a combination of hydrophilic and hydrophobic excipients to achieve controlled release and prolonged therapeutic effect. The final product undergoes rigorous physicochemical testing to ensure homogeneity, disintegration time, and dissolution profile compliance with pharmaceutical standards.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to meet the stringent demands of pharmaceutical production. The facility includes high-speed tablet compression machines, automated blending systems, and advanced coating units to ensure precision in formulation. Sterile processing capabilities are available through aseptic filling lines for sensitive active pharmaceutical ingredients (APIs). All production processes adhere to current Good Manufacturing Practices (cGMP) and are validated to ensure consistency and quality. The facility supports scalable production, enabling seamless transition from small-scale trials to large-volume manufacturing. Quality systems are integrated throughout the production lifecycle, including real-time monitoring, process validation, and continuous improvement protocols.
Available Strengths and Packaging
Preplin M is available in a single strength: Pregabalin 75mg + Nortriptyline 10mg + Methylcobalamin 1500mcg. The product is packaged in 10x10 Alu Alu blister packs, which provide robust protection against moisture, light, and physical damage. The aluminum-aluminum composite offers an extended shelf life and ensures compliance with pharmaceutical packaging standards for stability and safety.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our facility is equipped to handle complex formulations, customized packaging, and regulatory submissions, ensuring full compliance with global standards. We support both domestic and international clients by providing flexible production schedules, scalable capacity, and end-to-end supply chain management. Our expertise in API integration, formulation development, and packaging customization makes us a preferred partner for brands seeking to enter new markets or expand their product portfolios.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Each production batch undergoes extensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to confirm release profiles, and microbial limit checks for sterility. In-process controls and final product inspections ensure compliance with International Council for Harmonisation (ICH) and United States Pharmacopeia (USP) guidelines. All quality control data is documented and traceable, supporting regulatory submissions and audit readiness.
Regulatory Compliance
Preplin M is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international standards such as ISO 9001 and ISO 14001. Our facility is certified by regulatory authorities in multiple jurisdictions, including the FDA, EMA, and MHRA, ensuring alignment with global pharmaceutical regulations. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and deviation investigations. Our commitment to compliance extends to environmental management systems, ensuring sustainable and ethical manufacturing practices.
Global Supply Capability
We provide reliable global supply capabilities, supported by an extensive international distribution network and bulk supply capacity. Our logistics partners ensure timely delivery to over 50 countries, with options for air, sea, and land transport. Bulk supply is optimized through automated packaging lines and inventory management systems, enabling large-scale orders without compromising quality. Our supply chain is designed for resilience, with redundant systems to mitigate disruptions and ensure uninterrupted delivery. We also offer customized export solutions, including compliance with import regulations and documentation for international markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in complex formulation development, regulatory compliance, and scalable production. Our facility’s advanced infrastructure, combined with a dedicated quality team, ensures consistent product quality and timely delivery. We prioritize transparency, offering end-to-end support from formulation to global distribution. Our commitment to innovation, sustainability, and customer collaboration positions us as a reliable partner for businesses seeking to expand their market reach and meet evolving regulatory demands.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers and distributors worldwide.
FAQs
What manufacturing standards does Preplin M comply with?
Preplin M is manufactured in full compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global pharmaceutical regulations.
Can Preplin M be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization for alternative packaging formats upon request, including blister packs and strip packaging.
What is the shelf life of Preplin M?
Preplin M has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does your facility support sterile manufacturing processes?
Yes, our facility is equipped with aseptic filling lines to ensure sterile processing for sensitive APIs, including those requiring cGMP-compliant environments.
Can you handle private label manufacturing for Preplin M?
Absolutely. We offer private label manufacturing services, allowing brands to customize packaging, labeling, and branding while maintaining compliance with regulatory standards.
What quality control measures are in place for Preplin M?
Each batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial limit checks, ensuring compliance with ICH and USP guidelines.
What export capabilities do you offer for Preplin M?
We provide global export solutions, with logistics partnerships ensuring compliance with import regulations and seamless delivery to over 50 countries.
How does your supply chain ensure reliability?
Our supply chain is designed with redundancy and automation, ensuring uninterrupted bulk supply and timely delivery to meet global demand.
Can you scale production for large-volume orders?
Yes, our facility supports scalable production, enabling seamless transitions from small-scale trials to large-volume manufacturing.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client requirements, with options for both small and large-scale orders.
