Delzyme is formulated with a precise combination of pancreatin (192mg), bile constituents (25mg), and dimethicone (40mg), encapsulated in an enteric-coated tablet. The formulation leverages advanced excipient compatibility and coating technology to ensure stability, bioavailability, and controlled release. Pancreatin, a composite of pancreatic enzymes (lipase, protease, amylase), is critical for carbohydrate, protein, and fat digestion, while bile constituents enhance lipid emulsification. Dimethicone, a siloxane-based surfactant, reduces foam formation and improves gastric comfort. The enteric coating ensures the tablet remains intact in the stomach, releasing its contents in the alkaline environment of the small intestine, thereby optimizing enzymatic activity. The formulation is designed for pharmaceutical manufacturers requiring consistent quality, scalability, and compliance with global standards.
Manufacturing Capability
Delzyme is produced using state-of-the-art pharmaceutical manufacturing infrastructure, including automated tablet compression, coating, and packaging lines. The facility adheres to cGMP (Current Good Manufacturing Practice) standards, ensuring sterile processing, contamination control, and process validation. Advanced equipment for high-speed tablet compression and enteric coating ensures uniformity in tablet weight, disintegration, and dissolution. The manufacturing process incorporates quality by design (QbD) principles, with rigorous process analytical technology (PAT) to monitor critical quality attributes. Production scalability is achieved through modular manufacturing systems, enabling seamless transitions from small-scale trials to bulk supply. The facility’s quality systems include real-time monitoring, preventive maintenance, and data integrity protocols to guarantee compliance with regulatory requirements.
Available Strengths and Packaging
Delzyme is available in a single strength: Pancreatin 192mg + Bile Constituents 25mg + Dimethicone 40mg, formulated as an enteric-coated tablet. The product is packaged in 10x10 strips, ensuring convenient storage, distribution, and dosing for pharmaceutical buyers.
Contract Manufacturing / Third Party Manufacturing
Delzyme’s formulation and manufacturing process are fully scalable for third-party production, private label manufacturing, and contract manufacturing services. As a trusted pharmaceutical manufacturer, we offer end-to-end solutions for clients seeking to produce high-quality, compliant dosage forms. Our facility supports customized formulations, including adjustments to excipient ratios, coating technologies, and packaging formats. We provide flexible production timelines, regulatory documentation, and compliance support to meet the needs of global pharmaceutical buyers. Whether you require private labeling, contract manufacturing, or API sourcing, our team ensures seamless integration with your supply chain while maintaining adherence to international quality standards.
Quality Assurance
Delzyme’s quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with pharmaceutical standards. Each production batch undergoes comprehensive testing, including dissolution profiling, disintegration time, and microbial limit analysis. High-performance liquid chromatography (HPLC) and spectroscopy methods validate the purity and potency of active ingredients. Stability testing ensures shelf-life compliance under accelerated and long-term conditions. Quality control systems are integrated with electronic data capture (EDC) platforms to ensure traceability and data integrity. All processes adhere to ICH (International Council for Harmonisation) guidelines, USP (United States Pharmacopeia) standards, and WHO (World Health Organization) specifications, ensuring consistent quality for global markets.
Regulatory Compliance
Delzyme complies with cGMP, WHO guidelines, ISO 9001:2015, and international regulatory frameworks such as FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PIC/S (Pharmaceutical Inspection Convention). The manufacturing facility is certified under ISO 14001 for environmental management and ISO 45001 for occupational health and safety. All documentation, including batch records, stability reports, and deviation investigations, is prepared in accordance with regulatory requirements. The product meets specifications for export to over 150 countries, with compliance verified through audits, inspections, and regulatory submissions. Our commitment to regulatory excellence ensures seamless approval processes for global markets.
Global Supply Capability
Delzyme’s supply chain is designed for global reach, with established export capabilities and a robust international distribution network. Our facility supports bulk supply for large-scale pharmaceutical buyers, with logistics partnerships enabling efficient delivery to regional and international markets. The product is compatible with bulk storage and transportation requirements, ensuring minimal degradation during transit. Supply chain reliability is maintained through redundant inventory management, real-time tracking systems, and compliance with international shipping regulations. We provide tailored solutions for pharmaceutical exporters, including documentation for customs clearance, duty compliance, and import licenses. Our scalable production capacity ensures consistent supply to meet demand across multiple regions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delzyme for its combination of technical excellence, regulatory compliance, and supply chain reliability. Our facility’s adherence to cGMP, ISO, and WHO standards ensures product quality that meets global market demands. The enteric-coated formulation and precise composition offer a competitive edge in digestive enzyme therapy. With flexible manufacturing options, including private labeling and contract production, we cater to diverse client needs. Our commitment to innovation, quality assurance, and customer support positions us as a trusted partner for bulk supply and global distribution.
Bulk Supply Inquiry
Delzyme is available for bulk supply to meet the demands of pharmaceutical manufacturers and exporters. For inquiries regarding large-scale procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delzyme adhere to?
Delzyme is manufactured in compliance with cGMP, ISO 9001:2015, and WHO guidelines, ensuring adherence to global quality standards.
Can Delzyme be produced in different strengths?
Currently, Delzyme is available in a single strength (Pancreatin 192mg + Bile Constituents 25mg + Dimethicone 40mg). Custom formulations can be developed upon request.
What is the packaging format for Delzyme?
Delzyme is packaged in 10x10 strips, designed for convenient storage, distribution, and dosing.
Does Delzyme require special storage conditions?
Delzyme should be stored in a cool, dry place away from moisture and light, as per standard pharmaceutical storage guidelines.
Is Delzyme suitable for export to international markets?
Yes, Delzyme complies with regulatory requirements for export to over 150 countries, including FDA, EMA, and PIC/S standards.
What quality assurance measures are in place for Delzyme?
Each batch undergoes rigorous testing, including HPLC, dissolution profiling, and microbial analysis, ensuring compliance with ICH and USP standards.
Can Delzyme be produced under contract manufacturing agreements?
Yes, Delzyme’s formulation and manufacturing process are fully scalable for contract manufacturing, private labeling, and third-party production.
How does Delzyme’s supply chain ensure reliability?
Our global distribution network, combined with real-time tracking and redundant inventory management, ensures consistent supply and timely delivery.
What documentation is provided for regulatory compliance?
Comprehensive documentation, including batch records, stability reports, and regulatory submissions, is provided to meet international requirements.
How can I inquire about bulk supply of Delzyme?
For bulk supply inquiries, please contact our sales team at **info@delwishealthcare.com**.
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