Delzyme Syrup is a meticulously formulated enzymatic product combining Fungal Diastase (50mg) and Pepsin (10mg) in a sugar-free syrup base. The formulation is designed to ensure stability, bioavailability, and compatibility with pharmaceutical requirements. Fungal Diastase, derived from *Aspergillus niger*, is a proteolytic enzyme that aids in the breakdown of proteins, while Pepsin, a gastric enzyme, enhances peptide digestion. The syrup base is free from added sugars, making it suitable for patients with specific dietary needs. The excipients used in the formulation are selected to maintain the pH stability of the active ingredients, ensuring consistent performance during storage and administration. The product’s homogeneous dispersion of enzymes in the syrup matrix ensures uniform dosing and ease of administration. From a manufacturing perspective, the formulation is designed for scalability, with a focus on maintaining enzymatic activity and shelf-life stability through controlled excipient selection and process optimization.
Manufacturing Capability
Delzyme Syrup is manufactured in state-of-the-art pharmaceutical facilities equipped with advanced infrastructure to meet global GMP standards. The production process adheres to strict sterile processing protocols, ensuring contamination-free manufacturing of liquid formulations. Our facility is certified under ISO 9001 and ISO 14001, with dedicated areas for enzyme extraction, formulation, and packaging. The manufacturing line is capable of producing large volumes while maintaining precision in dosage uniformity and microbial control. The syrup formulation undergoes rigorous process validation to ensure consistent enzyme activity and product integrity. Our quality systems include real-time monitoring of critical parameters such as temperature, pH, and microbial load during production. The facility’s design supports seamless scalability, enabling rapid response to market demands without compromising product quality.
Available Strengths and Packaging
Delzyme Syrup is available in a single strength: Fungal Diastase 50mg + Pepsin 10mg. The product is packaged in 10x10 strips, ensuring efficient storage, distribution, and retail availability. The 10x10 strip format is ideal for bulk supply and pharmaceutical distribution channels, offering a balance between portability and large-scale dispensing. The packaging is designed to protect the syrup from light and moisture, maintaining its stability and efficacy during transit and storage.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, third-party production, and private label manufacturing services tailored to pharmaceutical buyers. Our capabilities include full-cycle production from raw material sourcing to finished product packaging, ensuring compliance with global regulatory standards. We specialize in customizing formulations to meet specific dosage requirements, packaging preferences, and labeling specifications. Our team collaborates closely with clients to align production processes with their quality control protocols, ensuring seamless integration into existing supply chains. Whether you require a private label product or a contract manufacturing solution, we provide flexible, scalable options that prioritize compliance, efficiency, and cost-effectiveness.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Every batch of Delzyme Syrup undergoes comprehensive testing for potency, purity, and microbial contamination. Analytical methods such as HPLC and UV spectrophotometry are employed to validate enzyme activity and ensure dosage accuracy. The product is tested for physical properties, including viscosity, clarity, and pH, to guarantee consistency in formulation. Our quality control systems are aligned with ICH, USP, and EP guidelines, ensuring compliance with global regulatory expectations. Traceability is maintained through detailed batch records, and all products are subjected to stability testing to confirm shelf-life accuracy.
Regulatory Compliance
Delzyme Syrup is manufactured in full compliance with GMP, WHO guidelines, and ISO standards, ensuring adherence to international regulatory frameworks. Our facility is certified under WHO GMP for pharmaceutical products, with regular audits to maintain compliance. The product meets specifications outlined in pharmacopoeias such as USP, EP, and BP, ensuring global market acceptance. We also comply with FDA, EMA, and PIC/S requirements for export to regulated markets. Our quality management system is designed to meet the demands of multinational pharmaceutical buyers, with documentation and reporting aligned to regulatory inspections.
Global Supply Capability
We have a robust global supply chain infrastructure, enabling seamless export and bulk supply to international markets. Our distribution network spans key pharmaceutical hubs, with partnerships in logistics and customs clearance to ensure timely delivery. The 10x10 strip packaging is optimized for bulk supply, supporting large-scale distribution to wholesalers, retailers, and healthcare providers. Our production capacity allows for flexible order fulfillment, with the ability to scale up or down based on demand. Supply chain reliability is ensured through redundant systems, real-time inventory tracking, and contingency planning for disruptions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our commitment to quality, compliance, and scalability. Our expertise in enzyme-based formulations, combined with advanced manufacturing capabilities, ensures consistent product performance. We offer competitive pricing without compromising on standards, making us a reliable partner for bulk supply. Our global regulatory compliance and logistics network enable seamless entry into international markets. Additionally, our dedicated customer support team provides tailored solutions to meet the unique needs of each buyer.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with customized solutions, including volume discounts, packaging options, and regulatory documentation.
FAQs
What manufacturing standards does Delzyme Syrup comply with?
Delzyme Syrup is manufactured in compliance with GMP, WHO guidelines, and ISO standards, ensuring adherence to global regulatory requirements.
Can Delzyme Syrup be produced in different packaging formats?
While the standard packaging is 10x10 strips, we offer customization options for bulk supply and specialized packaging formats upon request.
What is the shelf-life of Delzyme Syrup?
The product has a shelf-life of 24 months when stored under recommended conditions, as validated through stability testing.
Is Delzyme Syrup suitable for export to regulated markets?
Yes, our compliance with FDA, EMA, and PIC/S standards ensures seamless export to international markets.
Can you provide private label manufacturing for Delzyme Syrup?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own label.
What quality control measures are in place for Delzyme Syrup?
Each batch undergoes rigorous testing for potency, purity, and microbial contamination, with documentation aligned to ICH and USP guidelines.
How does your facility ensure sterile processing for liquid formulations?
Our facility employs sterile processing protocols, including cleanroom environments and validated filtration systems, to ensure contamination-free production.
What is the minimum order quantity for bulk supply?
We accommodate bulk supply requests with flexible order quantities, tailored to the buyer’s specific requirements.
Can you provide regulatory documentation for Delzyme Syrup?
Yes, we supply comprehensive regulatory documentation, including certificates of analysis, batch records, and compliance certificates.
How do you ensure supply chain reliability?
Our supply chain is supported by real-time inventory tracking, redundant systems, and partnerships with logistics providers to ensure timely delivery.
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