Prezin is a fixed-dose combination tablet formulated with Pregabalin 75mg and Methylcobalamin 750mcg, encapsulated in a caplet dosage form. The formulation leverages advanced excipient compatibility studies to ensure stability and uniformity, with excipients such as microcrystalline cellulose, magnesium stearate, and hydroxypropyl methylcellulose used to optimize disintegration, flow, and tablet hardness. The caplet design facilitates precise dosing and enhances patient compliance, while the combination of Pregabalin—a gabapentinoid used for neuropathic pain—and Methylcobalamin—a methylated form of vitamin B12—targets synergistic neuroprotective effects. The formulation undergoes rigorous physicochemical testing to ensure homogeneity, dissolution efficiency, and shelf-life stability under varied storage conditions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for high-volume tablet production, including automated high-speed tablet presses, aseptic processing lines, and advanced quality control systems compliant with current Good Manufacturing Practices (cGMP). The facility supports sterile processing for sensitive formulations, with controlled environments maintaining ISO Class 7洁净度 standards. Production scalability is ensured through modular design, enabling seamless transitions from small-scale trials to bulk manufacturing. Quality systems include real-time monitoring, in-process controls, and validated cleaning protocols to prevent cross-contamination. The facility is certified under ISO 9001:2015, with dedicated storage areas for raw materials, intermediates, and finished products to uphold batch traceability and product integrity.
Available Strengths and Packaging
Prezin is available in a single strength: Pregabalin 75mg + Methylcobalamin 750mcg caplets. The packaging is 10x10 Alu Alu, consisting of 10 blister packs per box, each containing 10 caplets. The aluminum blister packaging provides robust protection against moisture, light, and physical damage, ensuring product stability during storage and transport. This packaging format adheres to global pharmaceutical standards for moisture-resistant and child-resistant designs, making it ideal for both domestic and international markets.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include formulation development, API integration, and full-scale production of complex combinations like Prezin, with flexibility to accommodate custom specifications. We support private label manufacturing for brand-specific formulations, ensuring compliance with regulatory requirements and branding guidelines. For third-party partners, we provide end-to-end solutions, from raw material sourcing to finished product packaging, with transparent documentation and traceability. Our expertise in handling multi-ingredient combinations ensures consistent quality and adherence to global regulatory frameworks.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Each batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to ensure bioavailability, and microbial limit checks for sterility. In-process controls monitor critical parameters such as tablet hardness, disintegration time, and content uniformity. Final product testing includes physical characterization, stability studies, and packaging integrity assessments. All quality protocols are validated under ISO 17025 standards, ensuring consistency, safety, and regulatory compliance for global markets.
Regulatory Compliance
Prezin adheres to stringent regulatory frameworks, including current Good Manufacturing Practices (cGMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our manufacturing processes comply with global regulatory requirements for pharmaceuticals, including the U.S. FDA, EU GMP, and ICH guidelines. Documentation for regulatory submissions, such as stability data, batch records, and analytical reports, is maintained to support approvals in target markets. The facility is regularly audited by regulatory bodies and third-party inspectors to ensure ongoing compliance with evolving standards.
Global Supply Capability
We provide robust global supply capabilities, including export-ready manufacturing, international distribution networks, and bulk supply solutions. Our logistics partnerships ensure reliable delivery to over 50 countries, with compliance-ready documentation for customs and regulatory inspections. Bulk supply capacity is supported by scalable production lines, enabling orders ranging from small batches to large-scale commercialization. Supply chain reliability is guaranteed through redundant inventory systems, real-time tracking, and contingency planning to mitigate disruptions. We prioritize timely delivery while maintaining compliance with import regulations and quality standards across regions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in complex formulations, compliance with global standards, and scalable production capabilities. Our commitment to quality, combined with flexible manufacturing options and reliable supply chains, ensures competitive advantage in the pharmaceutical market. We offer tailored solutions to meet diverse market needs, from private label branding to bulk supply for global distribution. With a proven track record in regulatory compliance and innovation, we empower partners to deliver high-quality products efficiently and sustainably.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customized solutions, pricing, and logistics for Prezin.
FAQs
What manufacturing capabilities do you offer for Prezin?
We provide full-scale contract manufacturing, private label production, and third-party manufacturing services, ensuring compliance with cGMP and global regulatory standards.
Can you customize packaging for Prezin?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu blister packs, tailored to meet regional and market-specific requirements.
What quality control measures are in place for Prezin?
Each batch undergoes HPLC analysis, dissolution testing, microbial checks, and stability studies to ensure product integrity and compliance.
Is Prezin compliant with international regulatory standards?
Yes, our manufacturing processes adhere to WHO, FDA, EU GMP, and ISO 9001:2015 standards, with documentation for global regulatory submissions.
How do you ensure supply chain reliability for bulk orders?
We maintain redundant inventory systems, real-time tracking, and logistics partnerships to guarantee timely and compliant deliveries worldwide.
Can you support export-ready packaging for Prezin?
Yes, our 10x10 Alu Alu packaging meets international standards for moisture resistance, child safety, and regulatory compliance.
What is the minimum order quantity for bulk supply?
We accommodate small to large orders, with flexible production scaling to meet specific demand levels.
How do you handle regulatory documentation for Prezin?
We provide complete documentation, including stability data, batch records, and analytical reports, to support approvals in target markets.
Are there options for private label manufacturing?
Yes, we offer private label solutions, including branding, packaging customization, and compliance-ready documentation for market-specific requirements.
How can I inquire about bulk supply for Prezin?
Contact us at info@delwishealthcare.com for customized bulk supply inquiries, pricing, and logistics support.
