Preplin is a fixed-dose combination tablet formulated with Nortriptyline 10mg and Pregabalin 75mg, designed for pharmaceutical stability and consistent therapeutic performance. The formulation employs advanced excipient compatibility testing to ensure optimal dissolution, uniformity, and shelf-life stability. Nortriptyline, a tricyclic antidepressant, is combined with Pregabalin, an anticonvulsant, in a matrix that ensures controlled release and bioavailability. The tablet’s formulation incorporates hydrophilic and hydrophobic excipients to enhance solubility and disintegration properties, while maintaining mechanical strength for robust packaging. The manufacturing process adheres to strict pharmaceutical guidelines to ensure homogeneity, particle size distribution, and tablet hardness, with no compromise on quality or consistency. The final product is coated to ensure stability under varying environmental conditions and to minimize degradation risks during storage and transportation.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line includes automated tablet compression systems, high-precision blending equipment, and advanced coating technologies to ensure precision in formulation. Sterile processing capabilities are available for critical components, with dedicated cleanrooms maintaining Class 100–10,000 air quality standards. The facility supports scalable production, enabling seamless transitions from small batches to large-scale manufacturing while maintaining product integrity. Quality systems are integrated throughout the production lifecycle, including real-time monitoring, data integrity protocols, and traceability mechanisms. Our commitment to pharmaceutical excellence ensures compliance with regulatory requirements and consistent delivery of high-quality products.
Available Strengths and Packaging
Preplin is available in a single strength: Nortriptyline 10mg + Pregabalin 75mg tablets. The product is packaged in 10x10 Alu Alu blister packs, ensuring tamper-evidence, moisture resistance, and secure storage. This packaging format is ideal for pharmaceutical distribution, offering durability and compliance with global packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label and contract manufacturing for pharmaceutical buyers. Our capabilities extend to custom formulation development, dosage form optimization, and packaging solutions tailored to specific market requirements. We support global clients by providing end-to-end manufacturing solutions that meet regional regulatory standards and supply chain demands. Our flexibility in production scales and ability to adapt to diverse specifications make us a preferred partner for pharmaceutical companies seeking reliable, compliant manufacturing services.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Each production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC), dissolution testing, and microbial limit checks to ensure purity and potency. In-process controls are implemented at every stage of manufacturing to detect deviations early, while final product testing confirms compliance with pharmacopeial standards (e.g., USP, EP, BP). Quality control systems are integrated with digital traceability tools, enabling full transparency and audit readiness. We maintain a robust validation program for equipment, processes, and analytical methods, ensuring consistency and reliability in every batch.
Regulatory Compliance
Preplin’s manufacturing and quality processes are fully compliant with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 standards. Our facility is registered with regulatory authorities in key markets, including the FDA, EMA, and PMDA, ensuring alignment with global regulatory frameworks. We adhere to ICH guidelines for quality, safety, and efficacy, with documentation and reporting systems designed to meet the requirements of international regulatory bodies. Our commitment to compliance extends to environmental sustainability practices, ensuring responsible manufacturing and adherence to global ethical standards.
Global Supply Capability
We provide robust global supply capabilities, including export-ready manufacturing, international distribution networks, and bulk supply options for pharmaceutical buyers. Our logistics partners enable seamless delivery to over 150 countries, with customized solutions for regional market demands. Bulk supply capacity is supported by scalable production infrastructure, ensuring timely fulfillment of large orders without compromising quality. Our supply chain is designed for reliability, with redundant systems and real-time tracking to mitigate risks and ensure consistent delivery. We prioritize long-term partnerships, offering competitive pricing and flexible terms to meet the evolving needs of pharmaceutical distributors and exporters.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our unwavering commitment to quality, compliance, and reliability. Our end-to-end manufacturing capabilities, combined with global regulatory expertise, position us as a trusted supplier in the pharmaceutical industry. We offer competitive pricing, rapid turnaround times, and tailored solutions to meet diverse market needs. Our focus on innovation, sustainability, and customer-centric service ensures that partners receive value-added support throughout the supply chain. With a proven track record of compliance and operational excellence, we deliver products that meet the highest standards of safety and efficacy.
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 placements, customization requests, and supply chain coordination.
FAQs
What manufacturing standards does Preplin adhere to?
Preplin is manufactured in compliance with cGMP, ISO 9001:2015, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can Preplin be produced in different packaging formats?
While Preplin is currently available in 10x10 Alu Alu blister packs, we offer customization options for alternative packaging formats upon request.
What quality control measures are in place for Preplin?
Each batch undergoes rigorous testing, including HPLC, dissolution, and microbial limit checks, to ensure compliance with pharmacopeial standards.
Is Preplin suitable for export to international markets?
Yes, Preplin is manufactured to meet the regulatory requirements of global markets, including the FDA, EMA, and PMDA.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible, with minimum order quantities tailored to the scale of your operation. Contact us for customized solutions.
Can Preplin be produced with private label branding?
Yes, we offer private label manufacturing services, allowing clients to brand Preplin according to their market requirements.
How does your supply chain ensure reliability?
Our supply chain is supported by redundant systems, real-time tracking, and partnerships with global logistics providers to ensure consistent delivery.
What certifications does your facility hold?
Our facility is certified under cGMP, ISO 9001:2015, and WHO GMP, with regular audits to maintain compliance.
Can you accommodate urgent production requests?
We prioritize urgent orders and offer expedited production timelines to meet critical market demands.
How can I contact your team for further inquiries?
For bulk supply inquiries or technical support, please email **info@delwishealthcare.com**. Our team is available to assist with all your needs.
